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Last update 31 May 2025

Amoxicillin Trihydrate

Last update 31 May 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryAmoxicillin Trihydrate is a small molecule drug that belongs to the group of cell wall inhibitors, used as an antibiotic to treat bacterial infections such as bronchitis, pneumonia, urinary tract infections, and strep throat. Amoxicillin works by inhibiting the growth of bacteria by preventing the formation of their cell walls. The drug is available in various forms, including tablets, capsules, and oral suspension, and has been marketed under different brand names since its FDA approval in 1974. While generally safe, some individuals may experience side effects such as diarrhea, nausea, and skin rash. Those allergic to penicillin may also experience an allergic reaction to Amoxicillin. As with any medication, patients should follow the prescribed dosage and consult their healthcare provider if symptoms persist or worsen.

Drug Type

Small molecule drug

Synonyms

6-(p-hydroxy-α-aminophenylacetamido)penicillanic acid, AmoxiciIIin, Amoxicilin

+ [56]

Target

PBPs

Action

inhibitors

Mechanism

PBPs inhibitors(Bacterial penicillin-binding protein inhibitors)

Therapeutic Areas

Infectious DiseasesCardiovascular DiseasesRespiratory Diseases+ [2]

Active Indication

Endocarditis, BacterialGenitourinary tract infectionGonorrhea+ [4]

Inactive Indication

PharyngitisPulmonary TuberculosisTonsillitis

Originator Organization

GSK Plc

Active Organization

Meiji Seika Pharma Co., Ltd.

LTL Pharma Co., Ltd.

Sandoz Pty Ltd.

+ [3]

Inactive Organization

Pragma Pharmaceuticals LLC

GSK Plc

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (18 Jan 1974),

Tonsillitis

Regulation-

Structure/Sequence

Molecular FormulaC16H25N3O8S

InChIKeyMQXQVCLAUDMCEF-CWLIKTDRSA-N

CAS Registry61336-70-7

632

Clinical Trials associated with Amoxicillin Trihydrate

NCT06921213

/ Not yet recruitingPhase 2IIT

Comprehensive Ambulatory Antibiotics for the Treatment of Congenital Syphilis

CARES-1 is a randomised, open-label, phase II pharmacokinetic (PK) and safety study of ambulatory antibiotics for the treatment of neonates with "all-risk" asymptomatic congenital syphilis.

Start Date01 Oct 2025

Sponsor / Collaborator

London School of Hygiene & Tropical Medicine

[+5]

NCT06200779

/ Not yet recruitingPhase 4

Susceptibility-guided Vs. Empirical First-line Bismuth Quadruple Therapy of H. Pylori Infection: a National Prospective Multicentric Randomized Controlled Trial.

Helicobacter pylori (Hp) is a gram-negative bacterium that colonizes human gastric mucosa and is associated with chronic gastritis that can progress to severe complications such as peptic ulcer disease, gastric adenocarcinoma and gastric mucosa-associated lymphoid tissue lymphoma. More than half of the world's population is infected with H. pylori and Portugal is one of the countries with the highest Hp burden. All of infected patients should be treated, however, H. pylori treatment is challenged by the continuously rising antibiotic resistance which has reached alarming levels worldwide. For this reason, it is now well accepted that tailoring treatment of H. pylori infection based on systematic antimicrobial susceptibility testing is useful to avoid the increase of antibiotic resistance.
Our aims are to determine prospectively the efficacy and safety of first-line H. pylori eradication treatment based on resistance profile (determined by molecular methods) vs. empirical bismuth quadruple therapy, to evaluate the accuracy of H. pylori detection by polymerase chain reaction (PCR) (vs. histopathological examination) and to estimate the prevalence of H. pylori infection and H. pylori resistance to clarithromycin and levofloxacin in Portugal.
This prospective study will be the first national study to investigate the benefits of tailored H. pylori eradication treatment. The investigators expect that this project will be able to demonstrate the non-inferiority of susceptibility-guided treatment comparing with empirical therapy, and our results may change H. pylori treatment recommendations by systematically applying antibiotic susceptibility testing before prescribing eradication therapy.

Start Date01 Sep 2025

Sponsor / Collaborator

Unilabs Portugal

NCT06906757

/ Not yet recruitingNot ApplicableIIT

Preterm Rupture of Membranes Optimising Antibiotics Trial (PROMOAT). A Pregnancy Domain Within PLATIPUS.

The goal of this clinical trial is to learn which antibiotic regimen works best to prevent infection in pregnant women whose waters break early (preterm, pre-labour rupture of membranes, or PPROM) and assess the health outcomes of babies born to pregnant women who have received these antibiotics.
PROMOAT aims to answer the question: Which antibiotic or combined antibiotic regimen most effectively prevents infection in pregnant women with PPROM < 37+0 weeks' gestation.
Researchers will compare three antibiotic regimens already used in clinical practice to prevent infection in pregnant women with PPROM.
Participants will be randomly allocated to the antibiotic regimen they will follow for seven days, or until birth (whichever is earlier). All antibiotics will be taken orally.
Neonatal health outcomes will be collected at 42 weeks postmenstrual age and maternal birth and postpartum care outcomes assessed at 42 days postpartum.
Questionnaires will capture maternal mood at time of consent and at 42 days postpartum. Antibiotic tolerance will be assessed at the time antibiotic treatment is ceased.
This trial will be undertaken as part of the PLATIPUS trial (NCT06461429).

Start Date01 Sep 2025

Sponsor / Collaborator

University of Melbourne

100 Clinical Results associated with Amoxicillin Trihydrate

100 Translational Medicine associated with Amoxicillin Trihydrate

100 Patents (Medical) associated with Amoxicillin Trihydrate

42,982

Literatures (Medical) associated with Amoxicillin Trihydrate

31 Dec 2025·DRUG DELIVERY

Peptides rapidly transport antibiotic across the intact tympanic membrane to treat a middle ear infection

Article

Author: Kurabi, Arwa ; Ryan, Allen F. ; Sereno, Emily

The tympanic membrane (TM) forms an impenetrable barrier to medical therapies for middle ear (ME) diseases like otitis media. By screening a phage-displayed peptide library, we have previously discovered rare peptides that mediate the active transport of cargo across the intact membrane of animals and humans. Since the M13 filamentous bacteriophage on which the peptides are expressed are large (nearly 1 µm in length), this offers the possibility of noninvasively delivering drugs, large drug packages, or gene therapy to the ME. To evaluate this possibility, EDC chemistry was employed to covalently attach amoxicillin, or neomycin molecules to phage bearing a trans-TM peptide, as a model for large drug packages. Eight hours after application of antibiotic-phage to the TM of infected rats, ME bacterial titers were substantially reduced compared to untreated animals. As a control, antibiotic was linked to wild-type phage, not bearing any peptide, and application to the TM did not affect ME bacteria. The results support the ability of rare peptides to actively deliver pharmacologically relevant amounts of drugs through the intact TM and into the ME. Moreover, since bacteriophage engineered to express peptides are viral vectors, the trans-TM peptides could also transport other viral vectors into the ME.

31 Dec 2025·Environmental Pollutants and Bioavailability

Comprehensive toxicity assessment of selected pharmaceuticals (ciprofloxacin, amoxicillin, and levofloxacin) on freshwater microalgae Scenedesmus obliquus : effect of media composition

Author: Poddar, Bikram ; Bhattacharya, Bikramjit ; Mandal, Sanmitra ; Rex M, Camil ; Chandrsekaran, Natarajan ; Mukherjee, Amitava

Antibiotics are widely used in health care to treat various infections.Excessive use and poor waste management make antibiotics a serious threat to aquatic ecosystems.Most of the ecotoxicol. assessments on freshwater microalgae are evaluated in the defined culture medium, which lacks environmental relevance.Hence, this study aimed to evaluate the toxicity of amoxicillin, ciprofloxacin, and levofloxacin on the freshwater microalga Scenedesmus obliquus in both lake water medium (LWM) and Blue green-11 medium (BG-11 M).Results indicated that levofloxacin exhibited the highest toxicity, followed by amoxicillin and ciprofloxacin in both LWM and BG-11 M.Pearson correlation and cluster heat map analyses revealed that oxidative stress generation was directly linked to reduced photosynthetic activity and cell viability.These findings suggest toxicity assessments conducted in defined culture media may modulate the toxicity levels compared to environmentally relevant media, like lake water.

31 Dec 2025·Plant Signaling & Behavior

Exploring the efficacy of drought tolerant, IAA-producing plant growth-promoting rhizobacteria for sustainable agriculture

Article

Author: Nisar, Atif ; Uzma, Malika ; Iqbal, Atia ; Gull, Tehseen ; Hasnain, Shahida ; Castro-Muñoz, Roberto ; Rahim, Muhammad Abdul ; Zongo, Eliasse ; Mahmoud, Mohamed H.

The growing human population and abiotic stresses pose significant threats to food security, with PGPR favorable as biofertilizers for plant growth and stress relief. In one study, soil samples from both cultivated and uncultivated plants in various cities were used to isolate rhizobacterial populations. Using 50 soil samples from both cultivated and uncultivated plants, isolated rhizobacterial populations were screened for various biochemical changes, PGP activities and morphological characteristics. A total of 199 rhizobacteria were isolated and screened for IAA production. The strain M28 produced maximum IAA 378.44 ± 2.5 µg ml^-1, M9 formed only 34.72 ± 0.15 µg ml^-1. About 19% of IAA producers were isolated from Multan, 18% Lahore, 15% from soils of Faisalabad and Sheikhupura, while 7% from Gujrat. The 21 isolates were drought tolerant to -0.14Mpa, 14 of those were PSB and 15 were N fixers. In PGP traits, maximum zinc solubility was expressed by M4 as 2 ± 0.5 cm of zone. The strain M22 produced amount of HCN, 40.12 ± 0.052 ppm. All isolates showed diverse behavior in biocompatibility, motility patterns and hydrophobicity. Selected drought tolerant strains were genetically identified by ribotyping. Multitrait PGPR could be effective biofertilizers rather than with single trait. The strain M28 having highest production of IAA, was gelatinase, methyl red positive and was also capable of nitrogen fixation. Moreover, it had maximum swimming (8.9 mm) and swarming (8.7 mm) activities after 24 h, indicating its best PGP traits for future use.

240

News (Medical) associated with Amoxicillin Trihydrate

20 May 2025

·www.einpresswire.com

FishMoxFishFlex/Simple Pet Health LLC - 707196 - 05/08/2025

Delivery Method: VIA EMAIL WITH READ RECEIPT Product: Animal & Veterinary Drugs Recipient: Recipient Name Cameron Muir FishMoxFishFlex/Simple Pet Health LLC 520 South 850 East, Ste A1 Lehi , UT 84043 United States info@fishmoxfishflex.com Issuing Office: Center for Veterinary Medicine United States WARNING LETTER May 8, 2025 Re: 707196 Dear Cameron Muir: This letter concerns your firm's distribution of animal drug products for use in aquarium fish and birds. In April 2025, the U.S. Food and Drug Administration (FDA) reviewed your website (https://fishmoxfishflex.com/), where you take orders for Fish Mox and Fish Mox Forte Amoxicillin, Bird Zithro Azithromycin, Fish Flex Cephalexin and Fish Flex Forte Cephalexin, Fish Flox Forte Ciprofloxacin, Fish Cin Clindamycin, Fish Doxy Doxycycline, Fish Zole Metronidazole and Fish Zole Forte Metronidazole, Fish Pen Forte Penicillin, and Fish Sulfa Forte Sulfamethoxazole /Trimethoprim. The claims on your website establish that these products are intended for use in the cure, mitigation, treatment, or prevention of diseases in animals, which makes them drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. § 321(g)(1)(B)]. In addition, these animal drugs are misbranded under section 502(o) of the FD&C Act [21 U.S.C. § 352(o)] because they have not been drug listed with FDA, nor have they been manufactured in a facility that is registered with FDA in accordance with sections 510(b) and (j) of the FD&C Act [21 U.S.C. § 360(b), (j)]. As discussed below, introducing or delivering these unapproved and misbranded new animal drugs for introduction into interstate commerce violates section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. UNAPPROVED NEW ANIMAL DRUGS Examples of claims observed on your website (https://fishmoxfishflex.com/) that establish the intended use of these products as drugs include, but may not be limited to, the following: Fish • Simple Pet Health Fish Mox and Simple Pet Health Fish Mox Forte (Amoxicillin), 250 mg and 500 mg capsules. According to your website an “Antibacterial Fish Medication,” this product “is a broad-spectrum antibiotic that controls gram-positive and some gram-negative bacteria in fish. It works by halting the multiplication of bacteria associated with both fresh and salt water ornamental fish diseases. This fish antibiotic is useful for control of some common bacterial diseases in fish including Dropsy, Fin Rot, Red Pest, and disease caused by bacteria such as Aeromonas, Pseudomonas, and Mycobacterial (Gill diseases and Chondrococcus).” • Simple Pet Health Fish Flex and Simple Pet Health Fish Flex Forte (Cephalexin), 250 mg and 500 mg capsules. According to your website an “Antibacterial Fish Medication,” this product “is a broad-spectrum antibiotic that is used in treating a wide variety of non-specific bacterial infections during the most active and multiplying stages of infection. This effective fish antibiotic is helpful with treating a number of pathogenic bacteria associated with ornamental fish diseases.” • Simple Pet Health Fish Flox Forte (Ciprofloxacin), 500 mg tablets. According to your website an “Antibacterial Fish Medication,” “You can help your finned friends feel better and watch your aquarium thrive again with Ciprofloxacin Tablets. This synthetic, board spectrum medication is used treat different strains of bacteria that can plague your fish.” • Simple Pet Health Fish Cin (Clindamycin), 150 mg tablets. According to your website an “Antibacterial Fish Medication,” this product “is an antibiotic that exerts a bactericidal action on gram-positive and some gram-negative bacteria in fish. Used for the control of some common bacterial fish diseases, such as Aeromonas, Pseudomonas, and Mycobacterial (Gill diseases and Chondrococcus).” • Simple Pet Health Fish Doxy (Doxycycline Hyclate), 100 mg capsules. According to your website an “Antibacterial Fish Medication,” this product “is an antibiotic that exerts a bactericidal action on gram-positive and some gram-negative bacteria in fish. Used for the control of some common bacterial fish diseases such as Tail Rot, Mouth Rot, Fin Rot, and Septicemia.” • Simple Pet Health Fish Zole and Simple Pet Health Fish Zole Forte (Metronidazole), 250 mg and 500 mg tablets. According to your website an “Antibacterial Fish Medication,” this product “is an antibiotic that exerts a bactericidal action on gram-positive and some gram-negative bacteria in fish. Useful to help control some common bacterial diseases in fish such as Aeromonas, Pseudomonas, and Mycobacterial (Gill diseases and Chondrococcus). Effective against anaerobic bacteria, a bacteria that only grows where there is no oxygen. Also used to control parasitic diseases such as Cryptocaryon irritans, Ichthyophthirius multifiliis, and Hexamita.” • Simple Pet Health Fish Pen Forte (Penicillin), 500 mg tablets. According to your website an “Antibacterial Fish Medication,” this product “is an antibiotic that exerts a bactericidal action on gram-positive and some gram-negative bacteria in fish. Used in the control of some common bacterial diseases in fish, including diseases caused by bacteria such as fin and tail rot and Flexibacteria infections.” • Simple Pet Health Fish Sulfa Forte (Sulfamethoxazole/Trimethoprim), 800/160 mg tablets. According to your website an “Antibacterial Fish Medication,” this product “is an antibiotic that exerts a bactericidal action on gram-positive and some gram-negative bacteria in fish. Used in the control of some common bacterial diseases in fish, such as Aeromonas, Pseudomonas, and Mycobacterial (Gill diseases and Chondrococcus).” Birds • Simple Pet Health Bird Zithro (Azithromycin), 250 mg tablets. According to your website an “Antibacterial Bird Medication,” this product “is a fish antibiotic that is used for systemic and local infections in pigeons, pet birds, and exotic birds. This antibiotic is effective against gram-positive bacteria, as well as some gram-negative bacteria, spirochetes, anaerobic bacteria, and other types of microorganisms. Bird ZithroTM is also effective against Chlamydia psittaci in cockatiels. The active ingredient in this medication works by inhibiting the growth of bacteria, which helps to eliminate the bacteria and the infection.” These products are new animal drugs under section 201(v) of the FD&C Act [21 U.S.C. § 321(v)] because they are for use in nonfood-producing fish and birds, which are minor species as defined by sections 201(nn) and (oo) of the FD&C Act [21 U.S.C. § 321(nn) and (oo)], and are not the subject of a final FDA regulation finding either that the drugs are generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the drug’s labeling, or finding that the exception to the criterion in section 201(v)(1) of the FD&C Act has been met. To be legally marketed, a new animal drug must be the subject of an approved new animal drug application, a conditionally approved new animal drug application, or a listing on the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (“index listing”) under section 512, 571, or 572 of the FD&C Act [21 U.S.C. § 360b, 360ccc, and 360ccc-1]. The FDA approval and index listing processes allow FDA to ensure that there is adequate evidence to demonstrate that new animal drugs are safe, properly manufactured, accurately labeled, and meet the relevant effectiveness standard. The animal drugs named above have not been approved, conditionally approved, or index listed. Animal drugs that lack the required approval or index listing are considered unsafe and adulterated under sections 512(a) and 501(a)(5) of the FD&C Act [21 U.S.C. §§ 360b(a) and 351(a)(5)]. Introduction or delivery for introduction of an adulterated animal drug into interstate commerce is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. The FDA is particularly concerned about the marketing of these unapproved animal drugs because they contain antimicrobials considered medically important to human health. The growing threat of antimicrobial resistance, especially to drugs that are medically important in human medicine, has prompted FDA to promote judicious use of these drugs in animals. A key part of this effort is ensuring that these medically important antimicrobials are used only under the supervision of a licensed veterinarian. Over-the-counter use of these drugs without veterinary oversight contributes to the development of antimicrobial resistance, posing risks to both human and animal health. MISBRANDED NEW ANIMAL DRUGS Sections 510(b)(1) and (j)(1) of the FD&C Act [21 U.S.C. § 360(b), (j)] require that manufacturers (which includes repackers and relabelers) of drugs, including animal drugs, register their manufacturing establishments with FDA and provide the agency with a list of all the drug products they manufacture. Drugs that are manufactured in unregistered establishments or that have not been listed with FDA are misbranded under section 502(o) of the FD&C Act. None of the animal drugs in this letter are drug listed with FDA, nor have they been manufactured in a facility that is registered with FDA. Accordingly, these animal drugs are misbranded. Introduction or delivery for introduction of a misbranded animal drug into interstate commerce is prohibited under section 301(a) of the FD&C Act. This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your product(s). You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to legal or regulatory action, including without limitation, seizure and injunction. You should be aware that if we take enforcement action against any of the drugs named above or other unapproved/unindexed products you market that contain medically important antimicrobials, we may take action against all of your products that violate the FD&C Act at the same time, including but not limited to enjoining the manufacturing and distribution of all of your unapproved/unindexed products. We have the following comments: 1. You can legally market the products named above if you obtain an index listing, approval, or conditional approval. Information about the processes and requirements for obtaining an index listing and various types of animal drug approval is available on the FDA website at • https://www.fda.gov/animal-veterinary/development-approval-process/minor-useminor-species and • https://www.fda.gov/animal-veterinary/development-approval-process/new-animal-drug-applications The index listing process was added to the FD&C Act in 2004 as a streamlined alternative process that addresses the challenges of obtaining FDA approval for drugs for minor species (which are any animal species other than horses, cattle, pigs, dogs, cats, chickens, and turkeys). Drugs intended for use in minor species not used for human or animal food are eligible for index listing. Because the above-named products are intended for use in nonfood-producing fish and birds, you may wish to explore the index listing process. The approval process can also be used for drugs for use in these species. 2. Information on establishment registration and drug listing is available on the FDA website at: • https://www.fda.gov/industry/fda-basics-industry/registration-and-listing Within fifteen (15) working days of receiving this letter, please notify this office in writing of the specific steps that you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. Your written response should be sent to Dr. Vic Boddie, United States Food and Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance, Division of Drug Compliance, by emailing CVMUnapprovedDrugs@fda.hhs.gov. Sincerely, /S/ Cindy L. Burnsteel, DVM Acting Director, Division of Drug Compliance Office of Surveillance and Compliance Center for Veterinary Medicine Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

20 May 2025

·www.businesswire.com

ZEVTERA ® (ceftobiprole), an Advanced-Generation Cephalosporin Antibiotic Now Commercially Available in the U.S. to Treat Three Types of Bacterial Infections

WALTHAM, Mass.--(BUSINESS WIRE)--Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc. (Nasdaq: INVA), today announced the United States commercial availability of ZEVTERA® (ceftobiprole medocaril sodium for injection), the newest addition to the Company’s growing antibiotic portfolio. ZEVTERA is the only U.S. Food and Drug Administration (FDA) approved advanced-generation cephalosporin indicated to treat adult patients with Staphylococcus aureus bloodstream infection (bacteremia) (SAB), including those with right-side endocarditis caused by methicillin-susceptible and methicillin-resistant isolates.i ZEVTERA is the latest approved MRSA SAB therapy since 2006. “The availability of ZEVTERA in the U.S. marks the introduction of our second novel therapy in two years, addressing drug-resistant pathogens that pose significant health risks, particularly in hospitals and out-patient settings,” said Pavel Raifeld, Chief Executive Officer, Innoviva, Inc. “This portfolio expansion demonstrates our commitment to delivering therapies that offer physicians new options for treating some of the most challenging and potentially deadly diseases by leveraging our market-leading hospital platform.” MRSA, a strain of Staphylococcus aureus, has developed resistance to methicillin and many other commonly used antibiotics. Infections with MRSA have a high morbidity and mortality rate. Each year, over one hundred thousand individuals in the U.S. experience bacteremia caused by Staphylococcus aureus, with nearly 20,000 of these cases resulting in death. In April 2024, the U.S. FDA approved ZEVTERA for three indications. It is the only FDA-approved MRSA cephalosporin antibiotic for treating adult patients with SAB and right-side endocarditis. In addition to Staphylococcus aureus bacteremia, ZEVTERA is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI), and adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP).ii Unlike earlier-generation cephalosporins, ZEVTERA retains effectiveness against Gram-negative bacteria and provides activity against MRSA and methicillin-susceptible Staphylococcus aureus (MSSA). In the Phase 3 ERADICATE study, ceftobiprole met the primary endpoint by demonstrating non-inferiority versus daptomycin, with or without aztreonam. The overall success rate was 69.8% with ceftobiprole, compared to 68.7% with daptomycin, in the Modified Intention-to-Treat (mITT) population at 70 days post-randomization. Both treatments were well tolerated. The overall rate of adverse events was similar between the ceftobiprole and daptomycin groups.iii “ZEVTERA is an excellent addition to our antibiotics portfolio and its market availability further underscores our strategic commitment to deliver meaningful innovations in infectious diseases,” said David Altarac, M.D., Chief Medical Officer, Innoviva Specialty Therapeutics, Inc. “With the approval of ZEVTERA for three different indications, physicians and other health care providers will have a new option for serious bacterial infections, including Staphylococcal aureus bacteremia caused by methicillin-susceptible and methicillin-resistant isolates. Through our collaboration with specialty pharmacies and pharmacy distributors nationwide, ZEVTERA is available for immediate access.” Despite the availability of standard-of-care therapies, the mortality rate for SAB remains high, with approximately 30% of patients succumbing to the infection at 90 days.iv Patients with MRSA are three times more likely to experience prolonged bacteremia compared to those with methicillin-sensitive Staphylococcus aureus. Furthermore, MRSA bacteremia increased hospital length of stay and systemic infection vs. methicillin-susceptible Staphylococcus aureus (MSSA) bacteremia.v ZEVTERA is supplied in a single-dose vial containing 667 mg of ceftobiprole medocaril sodium (equivalent to 500 mg of ceftobiprole) as a lyophilized powder for intravenous infusion after reconstitution. Please visit www.innovivaspecialtytherapeutics.com for more information. ZEVTERA was developed by Basilea Pharmaceutica Ltd, Allschwil (“Basilea”) and received Priority Review, Fast Track, and Qualified Infectious Disease Product designations for the CABP, ABSSSI, and SAB indications. In December 2024, Innoviva Specialty Therapeutics, Inc., acquired exclusive U.S. marketing rights through a licensing agreement with Basilea. “We congratulate our partner Innoviva Specialty Therapeutics on making ZEVTERA available in the U.S., which marks a significant milestone for the brand,” said David Veitch, Chief Executive Officer of Basilea. “The U.S. is the most critical commercial market for newer antibacterials, and there is a substantial medical need for treatments targeting Staphylococcus aureus infections, particularly Staphylococcus aureus bacteremia. We are excited to support Innoviva Specialty Therapeutics in bringing ZEVTERA to patients in the U.S. who are suffering from these severe infections.” About MRSA According to the Centers for Disease Control and Prevention (CDC), methicillin-resistant Staphylococcus aureus (MRSA) is considered a serious public health threat. MRSA is a type of staph infection that has become resistant to commonly used antibiotics, including methicillin, oxacillin, penicillin, and amoxicillin. This resistance has contributed to MRSA's status as a significant public health concern. MRSA infections can lead to severe complications both in healthcare settings and in the community, including pneumonia, sepsis, surgical site infections, and endocarditis. Individuals at highest risk for contracting MRSA include those who have prolonged hospital stays, have been admitted to intensive care, underwent recent invasive procedures, or reside in nursing homes. Healthcare workers who come into direct contact with patients infected with MRSA are also at increased risk. About ZEVTERA® (ceftobiprole medocaril sodium for injection) Ceftobiprole, the active moiety of the prodrug ceftobiprole medocaril, is an advanced-generation cephalosporin antibiotic for intravenous administration, with rapid bactericidal activity against a wide range of Gram-positive bacteria, such as Staphylococcus aureus, including methicillin-resistant strains (MRSA), and Gram-negative bacteria. Outside the U.S., the brand is currently approved and marketed in several European countries and beyond as ZEVTERA® and Mabelio® for the treatment of adult patients with hospital-acquired bacterial pneumonia (HABP), excluding ventilator-associated bacterial pneumonia (VABP), and for the treatment of community-acquired bacterial pneumonia (CABP). Basilea has entered into license and distribution agreements covering more than 80 countries. INDICATIONS & USAGE Indications ZEVTERA® (ceftobiprole medocaril sodium for injection), for intravenous use, is indicated for the treatment of: Adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates. Adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following gram-positive and gram-negative microorganisms: Staphylococcus aureus (methicillin-susceptible and methicillin-resistant isolates), Streptococcus pyogenes, and Klebsiella pneumoniae . Adult and pediatric patients (3 months to less than 18 years) with community-acquired bacterial pneumonia (CABP) caused by susceptible isolates of the following gram-positive and gram-negative microorganisms: Staphylococcus aureus (methicillin- susceptible isolates), Streptococcus pneumoniae, Haemophilus influenzae , Haemophilus parainfluenzae , Escherichia coli , and Klebsiella pneumoniae . Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZEVTERA and other antibacterial drugs, ZEVTERA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. IMPORTANT SAFETY INFORMATION Contraindications: ZEVTERA is contraindicated in patients with a known history of severe hypersensitivity to ZEVTERA, or to other members of the cephalosporin class. Warnings and Precautions: Increased mortality with unapproved use in ventilator-associated bacterial pneumonia (VABP) Patients: The safety and effectiveness of ZEVTERA for the treatment of VABP has not been established and the use of ZEVTERA for VABP is not approved. Serious hypersensitivity reactions, including anaphylaxis, were observed in ZEVTERA-treated patients in clinical trials. Serious and occasionally fatal hypersensitivity reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Before therapy with ZEVTERA is instituted, careful inquiry about previous hypersensitivity reactions to other cephalosporins, penicillins, or other beta-lactam antibacterial drugs should be made. Maintain clinical supervision if this product is to be given to a penicillin- or other beta-lactam-allergic patient, because cross sensitivity among beta-lactam antibacterial agents has been established. Discontinue ZEVTERA if a hypersensitivity reaction occurs, and institute appropriate treatment. Seizures and other adverse central nervous system (CNS) reactions have been reported during treatment with ZEVTERA and other cephalosporins. If CNS adverse reactions, including seizures, occur, evaluate patients to determine whether ZEVTERA should be discontinued. Clostridioides difficile -associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including ZEVTERA, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, the risk/benefit of continuing treatment with ZEVTERA should be assessed. Adverse Reactions: SAB (adult patients): The most common adverse reactions occurring in ≥ 2% of adult patients were anemia, nausea, hypokalemia, vomiting, hepatic enzyme and bilirubin increased, diarrhea, blood creatinine increased, hypertension, leukopenia, pyrexia, abdominal pain, fungal infection, headache, and dyspnea. ABSSSI (adult patients): The most common adverse reactions occurring in ≥ 2% of adult patients were nausea, diarrhea, headache, injection site reaction, hepatic enzyme increase, rash, vomiting, and dysgeusia. CABP (adult and pediatric patients 3 months to less than 18 years of age): Adult Patients: The most common adverse reactions occurring in ≥ 2% of adult patients were nausea, hepatic enzyme increased, vomiting, diarrhea, headache, rash, insomnia, abdominal pain, phlebitis, hypertension, and dizziness. Pediatric Patients: The most common adverse reactions occurring in ≥ 2% of pediatric patients were vomiting, headache, hepatic enzyme increased, diarrhea, infusion site reaction, phlebitis, and pyrexia. Adult Patients: The most common adverse reactions occurring in ≥ 2% of adult patients were nausea, hepatic enzyme increased, vomiting, diarrhea, headache, rash, insomnia, abdominal pain, phlebitis, hypertension, and dizziness. Pediatric Patients: The most common adverse reactions occurring in ≥ 2% of pediatric patients were vomiting, headache, hepatic enzyme increased, diarrhea, infusion site reaction, phlebitis, and pyrexia. You are encouraged to report negative side effects of prescription drugs to the FDA. To report SUSPECTED ADVERSE REACTIONS, please contact: Innoviva Specialty Therapeutics, Inc.™ 1‑800‑651‑3861 medinfo@istx.com U.S. Food and Drug Administration 1‑800‑FDA‑1088 www.fda.gov/medwatch For smaller pieces, AE language can be: To report suspected adverse reactions, contact Innoviva Specialty Therapeutics, Inc. at 1‑800‑651‑3861 (medinfo@istx.com) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For full prescribing information, go to: https://innovivaspecialtytherapeutics.com/wp-content/uploads/2025/05/Prescribing-Information-Zevtera.pdf About Staphylococcus aureus bacteremia (SAB) Staphylococcus aureus bacteremia (SAB) is a serious bloodstream infection associated with significant morbidity and mortality. Complications include concomitant infections such as bone, joint or heart valve infections, persistent bacteremia or bacteremia in patients on dialysis. With a 30-day all-cause mortality of around 20% there is a high medical need for improved therapies for SAB.vi About acute bacterial skin and skin structure infections (ABSSSI) Acute bacterial skin and skin structure infections (ABSSSI) are common infections in healthcare settings. Staphylococcus aureus is the most common pathogen associated with these infections, which can be difficult to treat if methicillin-resistant Staphylococcus aureus (MRSA) is involved.vii About community-acquired bacterial pneumonia (CABP) Community-acquired bacterial pneumonia (CABP) is a leading cause of morbidity and mortality worldwide. It is the leading cause of infectious disease-related death in the US.viii About Basilea Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. Basilea is committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. Basilea has successfully launched two hospital brands, Cresemba (isavuconazonium sulfate), for the treatment of invasive fungal infections and ZEVTERA for the treatment of bacterial infections. In addition, the Company has preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit www.basilea.com. About Innoviva Innoviva is a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets. Innoviva’s royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (“GSK”). Innoviva is entitled to receive royalties from GSK on sales of RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®. Innoviva’s other innovative healthcare assets include infectious disease and critical care assets stemming from acquisitions of Entasis Therapeutics, including XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex and the investigational zoliflodacin currently being developed for the treatment of uncomplicated gonorrhea, and La Jolla Pharmaceutical Company, including GIAPREZA® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock and XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. On December 14, 2024, Innoviva entered into an exclusive distribution and license agreement with Basilea Pharmaceutica Ltd, Allschwil for the commercialization of ZEVTERA® (ceftobiprole), an advanced-generation cephalosporin antibiotic, in the U.S. ANORO®, RELVAR® and BREO® are trademarks of the GSK group of companies. ZEVTERA® is a trademark of Basilea Pharmaceutica Ltd, Allschwil. ____________________ i Full US prescribing information: https://www.basilea.com/ZEVTERA_US_prescribing_information_46b9y4wk ii U.S. Food and Drug Administration. (2024, April 3). FDA approves new antibiotic for three different uses. [FDA News Release] https://www.fda.gov/news-events/press-announcements/fda-approves-new-antibiotic-three-different-uses iii Holland TL, Cosgrove SE, Doernberg SB, et al. Ceftobiprole for treatment of complicated Staphylococcus aureus bacteremia. N Engl J Med. 2023 Oct 12;389(15):1390-1401. www.nejm.org/doi/full/10.1056/NEJMoa2300220 iv Van der Vaart, Thomas; All-Cause and Infection-Related Mortality in Staphylococcus aureus Bacteremia, a Multicenter Prospective Cohort Study; Open Forum Infectious Diseases; December 2022, Volume 9, Issue 12; https://academic.oup.com/ofid/article/9/12/ofac653/6854726 v Minejima, E., Mai, N., Bui, N., Mert, M., Mack, W. J., She, R. C., Nieberg, P., Spellberg, B., & Wong-Beringer, A. (2020). Defining the Breakpoint Duration of Staphylococcus aureus Bacteremia Predictive of Poor Outcomes. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 70(4), 566–573. https://doi.org/10.1093/cid/ciz257 vi K. Hamed, M. Engelhardt, M. E. Jones et al. Ceftobiprole versus daptomycin in Staphylococcus aureus bacteremia: a novel protocol for a double-blind, Phase III trial. Future Microbiology 2020 (1), 35-48 vii J. Edelsberg, C. Taneja, M. Zervos et al. Trends in US hospital admissions for skin and soft tissue infections. Emerging Infectious Diseases 2009 (15), 1516-1518 viii J. A. Ramirez, T. L. Wiemken, P. Peyrani et al. Adults hospitalized with pneumonia in the United States: Incidence, epidemiology, and mortality. Clinical Infectious Diseases 2017 (65), 1807-1812

Phase 3License out/inClinical ResultDrug ApprovalPriority Review

20 May 2025

·innovivaspecialtytherapeutics.com

ZEVTERA® (ceftobiprole), an Advanced-Generation Cephalosporin Antibiotic Now Commercially Available in the U.S. to Treat Three Types of Bacterial Infections

ZEVTERA is the first and only U.S. Food and Drug Administration-approved cephalosporin indicated to treat Staphylococcus aureus bacteremia (SAB), including right-sided endocarditis, caused by the methicillin-resistant Staphylococcus aureus (MRSA). Waltham, MA – May 20, 2025 – Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc. (Nasdaq: INVA), today announced the United States commercial availability of ZEVTERA® (ceftobiprole medocaril sodium for injection), the newest addition to the Company’s growing antibiotic portfolio. ZEVTERA is the only U.S. Food and Drug Administration (FDA) approved advanced-generation cephalosporin indicated to treat adult patients with Staphylococcus aureus bloodstream infection (bacteremia) (SAB), including those with right-side endocarditis caused by methicillin-susceptible and methicillin-resistant isolates.[i] ZEVTERA is the latest approved MRSA SAB therapy since 2006. “The availability of ZEVTERA in the U.S. marks the introduction of our second novel therapy in two years, addressing drug-resistant pathogens that pose significant health risks, particularly in hospitals and out-patient settings,” said Pavel Raifeld, Chief Executive Officer, Innoviva, Inc. “This portfolio expansion demonstrates our commitment to delivering therapies that offer physicians new options for treating some of the most challenging and potentially deadly diseases by leveraging our market-leading hospital platform.” MRSA, a strain of Staphylococcus aureus, has developed resistance to methicillin and many other commonly used antibiotics. Infections with MRSA have a high morbidity and mortality rate. Each year, over one hundred thousand individuals in the U.S. experience bacteremia caused by Staphylococcus aureus, with nearly 20,000 of these cases resulting in death. In April 2024, the U.S. FDA approved ZEVTERA for three indications. It is the only FDA-approved MRSA cephalosporin antibiotic for treating adult patients with SAB and right-side endocarditis. In addition to Staphylococcus aureus bacteremia, ZEVTERA is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI), and adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP).[ii] Unlike earlier-generation cephalosporins, ZEVTERA retains effectiveness against Gram-negative bacteria and provides activity against MRSA and methicillin-susceptible Staphylococcus aureus (MSSA). In the Phase 3 ERADICATE study, ceftobiprole met the primary endpoint by demonstrating non-inferiority versus daptomycin, with or without aztreonam. The overall success rate was 69.8% with ceftobiprole, compared to 68.7% with daptomycin, in the Modified Intention-to-Treat (mITT) population at 70 days post-randomization. Both treatments were well tolerated. The overall rate of adverse events was similar between the ceftobiprole and daptomycin groups.[iii] “ZEVTERA is an excellent addition to our antibiotics portfolio and its market availability further underscores our strategic commitment to deliver meaningful innovations in infectious diseases,” said David Altarac, M.D., Chief Medical Officer, Innoviva Specialty Therapeutics, Inc. “With the approval of ZEVTERA for three different indications, physicians and other health care providers will have a new option for serious bacterial infections, including Staphylococcal aureus bacteremia caused by methicillin-susceptible and methicillin-resistant isolates. Through our collaboration with specialty pharmacies and pharmacy distributors nationwide, ZEVTERA is available for immediate access.” Despite the availability of standard-of-care therapies, the mortality rate for SAB remains high, with approximately 30% of patients succumbing to the infection at 90 days.[iv] Patients with MRSA are three times more likely to experience prolonged bacteremia compared to those with methicillin-sensitive Staphylococcus aureus. Furthermore, MRSA bacteremia increased hospital length of stay and systemic infection vs. methicillin-susceptible Staphylococcus aureus (MSSA) bacteremia.[v] ZEVTERA is supplied in a single-dose vial containing 667 mg of ceftobiprole medocaril sodium (equivalent to 500 mg of ceftobiprole) as a lyophilized powder for intravenous infusion after reconstitution. Please visit www.innovivaspecialtytherapeutics.com for more information. ZEVTERA was developed by Basilea Pharmaceutica Ltd, Allschwil (“Basilea”) and received Priority Review, Fast Track, and Qualified Infectious Disease Product designations for the CABP, ABSSSI, and SAB indications. In December 2024, Innoviva Specialty Therapeutics, Inc., acquired exclusive U.S. marketing rights through a licensing agreement with Basilea. “We congratulate our partner Innoviva Specialty Therapeutics on making ZEVTERA available in the U.S., which marks a significant milestone for the brand,” said David Veitch, Chief Executive Officer of Basilea. “The U.S. is the most critical commercial market for newer antibacterials, and there is a substantial medical need for treatments targeting Staphylococcus aureus infections, particularly Staphylococcus aureus bacteremia. We are excited to support Innoviva Specialty Therapeutics in bringing ZEVTERA to patients in the U.S. who are suffering from these severe infections.” About MRSA According to the Centers for Disease Control and Prevention (CDC), methicillin-resistant Staphylococcus aureus (MRSA) is considered a serious public health threat. MRSA is a type of staph infection that has become resistant to commonly used antibiotics, including methicillin, oxacillin, penicillin, and amoxicillin. This resistance has contributed to MRSA’s status as a significant public health concern. MRSA infections can lead to severe complications both in healthcare settings and in the community, including pneumonia, sepsis, surgical site infections, and endocarditis. Individuals at highest risk for contracting MRSA include those who have prolonged hospital stays, have been admitted to intensive care, underwent recent invasive procedures, or reside in nursing homes. Healthcare workers who come into direct contact with patients infected with MRSA are also at increased risk. About ZEVTERA® (ceftobiprole medocaril sodium for injection) Ceftobiprole, the active moiety of the prodrug ceftobiprole medocaril, is an advanced-generation cephalosporin antibiotic for intravenous administration, with rapid bactericidal activity against a wide range of Gram-positive bacteria, such as Staphylococcus aureus, including methicillin-resistant strains (MRSA), and Gram-negative bacteria. Outside the U.S., the brand is currently approved and marketed in several European countries and beyond as ZEVTERA® and Mabelio® for the treatment of adult patients with hospital-acquired bacterial pneumonia (HABP), excluding ventilator-associated bacterial pneumonia (VABP), and for the treatment of community-acquired bacterial pneumonia (CABP). Basilea has entered into license and distribution agreements covering more than 80 countries. INDICATIONS & USAGE Indications ZEVTERA® (ceftobiprole medocaril sodium for injection), for intravenous use, is indicated for the treatment of: Adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates. Adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following gram-positive and gram-negative microorganisms: Staphylococcus aureus (methicillin-susceptible and methicillin-resistant isolates), Streptococcus pyogenes, and Klebsiella pneumoniae. Adult and pediatric patients (3 months to less than 18 years) with community-acquired bacterial pneumonia (CABP) caused by susceptible isolates of the following gram-positive and gram-negative microorganisms: Staphylococcus aureus (methicillin- susceptible isolates), Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Escherichia coli, and Klebsiella pneumoniae. Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZEVTERA and other antibacterial drugs, ZEVTERA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. IMPORTANT SAFETY INFORMATION Contraindications: ZEVTERA is contraindicated in patients with a known history of severe hypersensitivity to ZEVTERA, or to other members of the cephalosporin class. Warnings and Precautions: Increased mortality with unapproved use in ventilator-associated bacterial pneumonia (VABP) Patients: The safety and effectiveness of ZEVTERA for the treatment of VABP has not been established and the use of ZEVTERA for VABP is not approved. Serious hypersensitivity reactions, including anaphylaxis, were observed in ZEVTERA-treated patients in clinical trials. Serious and occasionally fatal hypersensitivity reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Before therapy with ZEVTERA is instituted, careful inquiry about previous hypersensitivity reactions to other cephalosporins, penicillins, or other beta-lactam antibacterial drugs should be made. Maintain clinical supervision if this product is to be given to a penicillin- or other beta-lactam-allergic patient, because cross sensitivity among beta-lactam antibacterial agents has been established. Discontinue ZEVTERA if a hypersensitivity reaction occurs, and institute appropriate treatment. Seizures and other adverse central nervous system (CNS) reactions have been reported during treatment with ZEVTERA and other cephalosporins. If CNS adverse reactions, including seizures, occur, evaluate patients to determine whether ZEVTERA should be discontinued. Clostridioides difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including ZEVTERA, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, the risk/benefit of continuing treatment with ZEVTERA should be assessed. Adverse Reactions: SAB (adult patients): The most common adverse reactions occurring in ≥ 2% of adult patients were anemia, nausea, hypokalemia, vomiting, hepatic enzyme and bilirubin increased, diarrhea, blood creatinine increased, hypertension, leukopenia, pyrexia, abdominal pain, fungal infection, headache, and dyspnea. ABSSSI (adult patients): The most common adverse reactions occurring in ≥ 2% of adult patients were nausea, diarrhea, headache, injection site reaction, hepatic enzyme increase, rash, vomiting, and dysgeusia. CABP (adult and pediatric patients 3 months to less than 18 years of age): Adult Patients: The most common adverse reactions occurring in ≥ 2% of adult patients were nausea, hepatic enzyme increased, vomiting, diarrhea, headache, rash, insomnia, abdominal pain, phlebitis, hypertension, and dizziness. Pediatric Patients: The most common adverse reactions occurring in ≥ 2% of pediatric patients were vomiting, headache, hepatic enzyme increased, diarrhea, infusion site reaction, phlebitis, and pyrexia. You are encouraged to report negative side eﬀects of prescription drugs to the FDA. To report SUSPECTED ADVERSE REACTIONS, please contact: Innoviva Specialty Therapeutics, Inc.™ 1‑800‑651‑3861 medinfo@istx.com U.S. Food and Drug Administration 1‑800‑FDA‑1088 www.fda.gov/medwatch For smaller pieces, AE language can be: To report suspected adverse reactions, contact Innoviva Specialty Therapeutics, Inc. at 1‑800‑651‑3861 (medinfo@istx.com) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For full prescribing information, go to: https://innovivaspecialtytherapeutics.com/wp-content/uploads/2025/05/Prescribing-Information-Zevtera.pdf About Staphylococcus aureus bacteremia (SAB) Staphylococcus aureus bacteremia (SAB) is a serious bloodstream infection associated with significant morbidity and mortality. Complications include concomitant infections such as bone, joint or heart valve infections, persistent bacteremia or bacteremia in patients on dialysis. With a 30-day all-cause mortality of around 20% there is a high medical need for improved therapies for SAB.[vi] About acute bacterial skin and skin structure infections (ABSSSI) Acute bacterial skin and skin structure infections (ABSSSI) are common infections in healthcare settings. Staphylococcus aureus is the most common pathogen associated with these infections, which can be difficult to treat if methicillin-resistant Staphylococcus aureus (MRSA) is involved.[vii] About community-acquired bacterial pneumonia (CABP) Community-acquired bacterial pneumonia (CABP) is a leading cause of morbidity and mortality worldwide. It is the leading cause of infectious disease-related death in the US.[viii] About Basilea Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. Basilea is committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. Basilea has successfully launched two hospital brands, Cresemba (isavuconazonium sulfate), for the treatment of invasive fungal infections and ZEVTERA for the treatment of bacterial infections. In addition, the Company has preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit www.basilea.com. About Innoviva Innoviva is a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets. Innoviva’s royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (“GSK”). Innoviva is entitled to receive royalties from GSK on sales of RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®. Innoviva’s other innovative healthcare assets include infectious disease and critical care assets stemming from acquisitions of Entasis Therapeutics, including XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex and the investigational zoliflodacin currently being developed for the treatment of uncomplicated gonorrhea, and La Jolla Pharmaceutical Company, including GIAPREZA® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock and XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. On December 14, 2024, Innoviva entered into an exclusive distribution and license agreement with Basilea Pharmaceutica Ltd, Allschwil for the commercialization of ZEVTERA® (ceftobiprole), an advanced-generation cephalosporin antibiotic, in the U.S. ANORO®, RELVAR® and BREO® are trademarks of the GSK group of companies. ZEVTERA® is a trademark of Basilea Pharmaceutica Ltd, Allschwil. Investors and Media: Innoviva, Inc. David Patti Corporate Communications (908) 421-5971 david.patti@inva.com Eleanor Barisser Investor Relations Eleanor.barisser@inva.com [i] Full US prescribing information: https://www.basilea.com/ZEVTERA_US_prescribing_information_46b9y4wk [ii] U.S. Food and Drug Administration. (2024, April 3). FDA approves new antibiotic for three different uses. [FDA News Release] https://www.fda.gov/news-events/press-announcements/fda-approves-new-antibiotic-three-different-uses [iii] Holland TL, Cosgrove SE, Doernberg SB, et al. Ceftobiprole for treatment of complicated Staphylococcus aureus bacteremia. N Engl J Med. 2023 Oct 12;389(15):1390-1401. www.nejm.org/doi/full/10.1056/NEJMoa2300220 [iv] Van der Vaart, Thomas; All-Cause and Infection-Related Mortality in Staphylococcus aureus Bacteremia, a Multicenter Prospective Cohort Study; Open Forum Infectious Diseases; December 2022, Volume 9, Issue 12; https://academic.oup.com/ofid/article/9/12/ofac653/6854726 [v] Minejima, E., Mai, N., Bui, N., Mert, M., Mack, W. J., She, R. C., Nieberg, P., Spellberg, B., & Wong-Beringer, A. (2020). Defining the Breakpoint Duration of Staphylococcus aureus Bacteremia Predictive of Poor Outcomes. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 70(4), 566–573. https://doi.org/10.1093/cid/ciz257 [vi] K. Hamed, M. Engelhardt, M. E. Jones et al. Ceftobiprole versus daptomycin in Staphylococcus aureus bacteremia: a novel protocol for a double-blind, Phase III trial. Future Microbiology 2020 (1), 35-48 [vii] J. Edelsberg, C. Taneja, M. Zervos et al. Trends in US hospital admissions for skin and soft tissue infections. Emerging Infectious Diseases 2009 (15), 1516-1518 [viii] J. A. Ramirez, T. L. Wiemken, P. Peyrani et al. Adults hospitalized with pneumonia in the United States: Incidence, epidemiology, and mortality. Clinical Infectious Diseases 2017 (65), 1807-1812

Phase 3Clinical ResultLicense out/inDrug ApprovalQualified Infectious Disease Product

100 Deals associated with Amoxicillin Trihydrate

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KEGG	Wiki	ATC	Drug Bank
D00229	Amoxicillin Trihydrate	J01CA04	DB01060

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Endocarditis, Bacterial	Australia	Sandoz Pty Ltd.	22 May 2008
Genitourinary tract infection	Australia	Sandoz Pty Ltd.	22 May 2008
Gonorrhea	Australia	Sandoz Pty Ltd.	22 May 2008
Respiratory Tract Infections	Australia	Sandoz Pty Ltd.	22 May 2008
Skin and skin structure infections	Australia	Sandoz Pty Ltd.	22 May 2008
Pharyngitis	United States	Pragma Pharmaceuticals LLC	23 Jan 2008
Bacterial Infections	United States	USAntibiotics	21 Oct 1980
Infectious Diseases	Japan	LTL Pharma Co., Ltd.	06 Sep 1974
Infectious Diseases	Japan	Sandoz AG	06 Sep 1974
Tonsillitis	United States	GSK Plc	18 Jan 1974

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Pulmonary Tuberculosis	Phase 2	South Africa	GSK Plc	01 Sep 2014

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


UEGW2024	Not Applicable	Infectious Diseases First line	439	EA (esomeprazole-amoxicillin)	jxuctitunn(ygawnqtzfl) = jxytxqskge ydhajarwbo (jjxcufromq )	Positive	13 Oct 2024
				B-quadruple (esomeprazole-amoxicillin-clarithromycin-bismuth)	jxuctitunn(ygawnqtzfl) = auwofbnxnr ydhajarwbo (jjxcufromq )
EURETINA2024	Not Applicable	Myopia \| Pneumonia	-	Amoxicillin	ithyjnblpg(znleaidovm) = This clinical case suggests a potential episode of secondary uveal effusion with amoxicillin as the most probable etiology, based on the temporal sequence of events. However, the possibility of an infectious or inflammatory contribution due to the patient's current pneumonia or previous flu-like symptoms cannot be ruled out. Moreover, the temporal coincidence between the onset of ophthalmological symptoms two days after the initiation of amoxicillin administration, as well as the observation of clinical improvement two days after discontinuing the medication, significantly suggests the possible involvement of amoxicillin in the development of the uveal effusion. vtqtmhtjfs (gnulzvbmdv )	-	19 Sep 2024
				Azithromycin
NCT05010304 (CTgov)	Phase 4	Allergy to penicillin	23	Amoxicillin	euxoombnpk = yxgtazlvel nguvtltpkq (tosrtlbpqh, nxkxofccyt - gqziomoxfz) View more	-	14 Aug 2024
NCT05901051 (Pubmed \| Helicobacter)	Phase 4	Helicobacter pylori infection	327	Vonoprazan 20 mg + Amoxicillin 1000 mg BM-TID	ssegdsjopi(hbyivjbucx) = zhduidzeib uypzyenhtl (hshwzefiei )	Positive	01 Jul 2024
				Vonoprazan 20 mg + Amoxicillin 1000 mg AM-TID	ssegdsjopi(hbyivjbucx) = vmnugraoqp uypzyenhtl (hshwzefiei )
NCT03060473 (TREAT, CTgov)	Phase 3	Preterm Premature Rupture of the Membranes	21	Amoxicillin+Azithromycin+Ampicillin (Azithromycin)	ssbietvyeb(tsnsqxboww) = hfeowbbowj nbypfkrkru (ruswwlshxr, irxrqmzeqh - sfctrkbnrg) View more	-	25 Jun 2024
				Erythromycin+Amoxicillin+Ampicillin (Erythromycin)	ssbietvyeb(tsnsqxboww) = fyieyplnpg nbypfkrkru (ruswwlshxr, wsfljqepmh - jxknnaekys) View more
NCT05719831 (Pubmed \| Clin Gastroenterol Hepatol)	Phase 3	Helicobacter pylori infection	623	H-VA-10 (vonoprazan 20 mg b.i.d. + amoxicillin 750 mg 4 times a day, 10 days)	xklwkzfaum(wvidueoyaz) = axodaelsqr rdnoodbqnq (wfaithwcay )	Positive	01 Jun 2024
				L-VA-10 (vonoprazan 20 mg b.i.d. + amoxicillin 1000 mg b.i.d, 10 days)	xklwkzfaum(wvidueoyaz) = giycilhneh rdnoodbqnq (wfaithwcay )
NCT03404804 (OPEN, CTgov)	Phase 4	Allergy to penicillin	116	Amoxicillin	dtmzfzmxel = uqxhvtkjww ponxbgogfi (pwvesqannq, riveivergz - apibnfzqnv) View more	-	16 May 2024
NCT05870683 (SHARE2301, Pubmed \| Helicobacter)	Not Applicable	Helicobacter pylori infection	368	Tegoprazan-amoxicillin (TA)	yvwksfgblz(bdpgbvxqas) = feyfcwsbjl glgukexosh (eobmwexyna )	Positive	01 May 2024
				Esomeprazole-amoxicillin (EA)	yvwksfgblz(bdpgbvxqas) = gcmtaetryt glgukexosh (eobmwexyna )
AAAAI2024	Not Applicable	Hypersensitivity LPS	-	Amoxicillin + Lipopolysaccharide	kocbgexvqm(fevuceuacg) = ogxfpwjvpg atddasxeqj (yleuefhpfg ) View more	Positive	23 Feb 2024
				Amoxicillin	kocbgexvqm(fevuceuacg) = koykuweoue atddasxeqj (yleuefhpfg ) View more
ChiCTR2300070100 (Pubmed \| Am J Gastroenterol)	Phase 4	Helicobacter pylori infection First line	314	Vonoprazan-Amoxicillin Dual Therapy	xdgaedyhax(hdekiyvkbd) = kjkuwmurto uzrflsbpvz (qrwsmrhyom )	Positive	11 Dec 2023
				Bismuth-Based Quadruple Therapy	xdgaedyhax(hdekiyvkbd) = gwtnuwyldv uzrflsbpvz (qrwsmrhyom )

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