Steady state telithromycin pharmacokinetics and pharmacodynamic in adult patients with mild-moderate acute exacerbation of chronic obstructive pulmonary disease treated with a standard oral dose 800 mg od for 5 days - TELI AECOPD

Start Date12 Sep 2006

Sponsor / Collaborator-

NCT00315042 / TerminatedPhase 3

Multinational, Randomized, Double-Blind, Double Dummy, Comparative Study to Evaluate the Efficacy and Safety of 5 Days Telithromycin 25mg/kg od Versus 10 Days Penicillin V 13.3 mg/kg Tid in Children 6 Months to Less Than 13 Years With Streptococcus Pyogenes Tonsillitis/Pharyngitis

This is a multinational, randomized (1:1), double blind, double dummy, comparator-controlled, 2 parallel treatment group study in subjects from 6 months to < 13 years of age, with Streptococcus pyogenes tonsillitis/pharyngitis (T/P).Each subject will receive either telithromycin 25 mg/kg once daily for 5 days or penicillin V, 13.3 mg/kg three times daily for 10 days. Matching placebo for telithromycin and penicillin V will also be dispensed for 5 and 10 days respectively, to provide blinding to the different treatment regimens. A positive rapid identification test for streptococcal Group A antigen will be required for all subjects at Visit 1 (Day 1) for entry into the study. Throat swab specimens for bacterial culture, identification, and antibiotic-susceptibility testing will be taken at Visits 1, 3 and 4.

Start Date01 Mar 2006

Sponsor / Collaborator

Sanofi

NCT00315549 / TerminatedPhase 3

Multinational, Randomized, Double Blind, Comparative Study to Evaluate the Efficacy and Safety of 5 Days Telithromycin 800 mg od Versus 10 Days Penicillin V 500 mg Tid in Adolescent and Adult Subjects Equal to or Over 13 Years With Streptococcus Pyogenes Tonsillitis/Pharyngitis

This is a multinational, randomized (1:1), double blind, comparator-controlled, 2 parallel treatment group study in subjects equal to or over 13 years of age, with Streptococcus pyogenes tonsillitis/pharyngitis (T/P). Each subject will receive either telithromycin, 400 mg over-encapsulated tablets, 800 mg once daily for 5 days or penicillin V 250 mg over-encapsulated tablets, 500 mg three times daily for 10days. Matching placebo capsules will be dispensed to maintain the blind between the treatment groups.A positive rapid identification test for streptococcal Group A antigen will be required for all subjects at Visit 1 (Day 1) for entry into the study. Throat swab specimens for bacterial culture, identification, and antibiotic-susceptibility testing will be taken at Visits 1, 3 and 4.

Start Date01 Feb 2006

Sponsor / Collaborator

Sanofi

100 Clinical Results associated with Telithromycin

100 Translational Medicine associated with Telithromycin

100 Patents (Medical) associated with Telithromycin

903

Literatures (Medical) associated with Telithromycin

21 Sep 2024·Journal of biomolecular structure & dynamics

Structure-based drug designing against Leishmania donovani using docking and molecular dynamics simulation studies: exploring glutathione synthetase as a drug target

Article

Author: Dubey, Vikash Kumar ; Borkotoky, Subhomoi ; Sarma, Manash

In the pursuit of developing novel anti-leishmanial agents, we conducted an extensive computational study to screen inhibitors from the FDA-approved ZINC database against Leishmania donovani glutathione synthetase. The three-dimensional structure of Leishmania donovani glutathione synthetase was constructed by homology modeling, using the crystallographic structure of Trypanosoma brucei glutathione synthetase as a template. Subsequently, molecular docking studies were carried out for a large number of compounds using AutoDock Vina. Among the screened compounds, we selected the top five with strong binding affinity to Leishmania donovani glutathione synthetase but having a very low affinity to its human homolog. Further investigations on protein-ligand complexes were done by conducting molecular dynamics (MD) simulation and MM/PBSA analysis. The results revealed that Olysio (Simeprevir) exhibited the lowest binding energy (-89.21 kcal/mol), followed by Telithromycin (-45.34 kcal/mol). These findings showed that these compounds have the potential to act as inhibitors of glutathione synthetase. Hence, our study provides valuable insights for the development of a novel therapeutic strategy against Leishmania donovani by targeting the glutathione synthetase enzyme.Communicated by Ramaswamy H. Sarma.

01 May 2024·Journal of general internal medicine

Identifying the Best Initial Oral Antibiotics for Adults with Community-Acquired Pneumonia: A Network Meta-Analysis

Review

Author: Ebell, Mark H ; Kurotschka, Peter K ; Hulme, Cassie ; Bentivegna, Michelle

BACKGROUND:

The objective of this network meta-analysis was to compare rates of clinical response and mortality for empiric oral antibiotic regimens in adults with mild-moderate community-acquired pneumonia (CAP).

METHODS:

We searched PubMed, Cochrane, and the reference lists of systematic reviews and clinical guidelines. We included randomized trials of adults with radiologically confirmed mild to moderate CAP initially treated orally and reporting clinical cure or mortality. Abstracts and studies were reviewed in parallel for inclusion in the analysis and for data abstraction. We performed separate analyses by antibiotic medications and antibiotic classes and present the results through network diagrams and forest plots sorted by p-scores. We assessed the quality of each study using the Cochrane Risk of Bias framework, as well as global and local inconsistency.

RESULTS:

We identified 24 studies with 9361 patients: six at low risk of bias, six at unclear risk, and 12 at high risk. Nemonoxacin, levofloxacin, and telithromycin were most likely to achieve clinical response (p-score 0.79, 0.71, and 0.69 respectively), while penicillin and amoxicillin were least likely to achieve clinical response. Levofloxacin, nemonoxacin, azithromycin, and amoxicillin-clavulanate were most likely to be associated with lower mortality (p-score 0.85, 0.75, 0.74, and 0.68 respectively). By antibiotic class, quinolones and macrolides were most effective for clinical response (0.71 and 0.70 respectively), with amoxicillin-clavulanate plus macrolides and beta-lactams being less effective (p-score 0.11 and 0.22). Quinolones were most likely to be associated with lower mortality (0.63). All confidence intervals were broad and partially overlapping.

CONCLUSION:

We observed trends toward a better clinical response and lower mortality for quinolones as empiric antibiotics for CAP, but found no conclusive evidence of any antibiotic being clearly more effective than another. More trials are needed to inform guideline recommendations on the most effective antibiotic regimens for outpatients with mild to moderate CAP.

01 Mar 2024·Journal de mycologie medicale

Pythium insidiosum: In vitro oomicidal evaluation of telithromycin and interactions with azithromycin and amorolfine hydrochloride

Article

Author: Maciel, Aline Fontanella ; Ianiski, Lara Baccarin ; Botton, Sônia de Avila ; Sangioni, Luis Antônio ; Pal, Mahendra ; Pereira, Daniela Isabel Brayer ; Colla, Ana Carolina Nolasco ; Santurio, Janio Morais ; Braga, Caroline Quintana

This study evaluated the repositioning of the ketolide antibacterial telithromycin (TLT) against the oomycete Pythium insidiosum and verified the combination of TLT and the antimicrobials azithromycin (AZM) and amorolfine hydrochloride (AMR), which have known anti-P. insidiosum activity. Susceptibility tests of P. insidiosum isolates (n = 20) against the drugs were carried out according to CLSI protocol M38-A2, and their combinations were evaluated using the checkerboard microdilution method. The minimum inhibitory concentrations were 0.5-4 µg/mL for TLT, 2-32 µg/mL for AZM, and 16-64 µg/mL for AMR. For the TLT+AZM combination, 52.75 % of interactions were indifferent, 43.44 % were antagonistic, and 9.70 % were synergistic. As for interactions of the TLT+AMR combination, 60.43 % were indifferent, 39.12 % were antagonistic, and 10.44 % synergistic interactions. This study is the first to evaluate the repositioning of the antibacterial TLT against mammalian pathogenic oomycetes, and our results show that its isolated action is superior to its combinations with either AZM or AMR. Therefore, we recommend including TLT in future research to evaluate therapeutic approaches in different clinical forms of human and animal pythiosis.

News (Medical) associated with Telithromycin

26 Sep 2024

·www.businesswire.com

Vertex Highlights First Oral Presentation of Phase 3 Clinical Data of the Vanza Triple and New Data on Long-Term Impact of TRIKAFTA® at the North American Cystic Fibrosis Conference

BOSTON--( BUSINESS WIRE )-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the first accepted medical presentations of the Phase 3 data on the investigational once daily vanzacaftor/tezacaftor/deutivacaftor (“vanza triple”) — the potential next-in-class triple combination medicine — will take place at the North American Cystic Fibrosis Conference (NACFC). Vertex also announced presentations describing long-term outcomes in people with cystic fibrosis (CF) ages 2 to 11 years taking TRIKAFTA ® , demonstrating consistent and sustained improvements across multiple measures of disease. “ TRIKAFTA has transformed the treatment of CF in the 5 years since its approval, changing the outlook for patients with CF,” said Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer at Vertex. “ Toward our goal to bring all eligible patients to normal levels of CFTR function, we have made global regulatory submissions for our next-in-class vanza triple combination medicine for patients with CF aged 6 years and older. We are excited to bring this promising new medicine, which has the potential to deliver even greater improvements in sweat chloride, to patients with CF.” Data on the Investigational Once Daily Next-in-Class Triple Combination Therapy, vanzacaftor/tezacaftor/deutivacaftor Vertex will present data on the vanza triple in an oral presentation and two posters on Friday, September 27. This is the first time that the clinical data from the Phase 3 clinical trials of the vanza triple in patients 6 years and older with CF have been accepted for presentation at a medical meeting. These data formed the basis of global regulatory submissions. “ The additional, significant reductions in sweat chloride we see in the vanza triple clinical trials are noteworthy. I believe this improvement in CFTR function may lead to important benefits for people with CF,” said Claire L. Keating, M.D., Co-Director of the Gunnar Esiason Adult Cystic Fibrosis and Lung Program at Columbia University. “ If approved, as a clinician, I’m looking forward to being able to offer patients an option, with once daily dosing, that could advance the treatment for people living with CF.” Data from the Phase 3 clinical studies of the vanza triple will be presented in the following sessions: “ Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ Triple) in Adolescents and Adults with CF: Results from Two Randomized, Active-Controlled Phase 3 Trials,” will be an oral presentation during a session entitled: “Cutting Edge Research: What’s New” on Friday, September 27, from 10:15 a.m. to 12:15 p.m. EDT and be a poster presentation on Friday, September 27, from 1:15-2:15 p.m. EDT. “ Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ Triple) in Children 6 Through 11 Years of Age with Cystic Fibrosis,” will be a poster presentation on Friday, September 27, from 1:15-2:15 p.m. EDT. The vanza triple was granted Fast Track and Orphan Drug Designations from the U.S. Food and Drug Administration (FDA) for the treatment of CF and has been submitted for regulatory approval in the U.S., Canada, U.K., EU, Switzerland, Australia and New Zealand. Vertex has been assigned a Prescription Drug User Fee Act (PDUFA) date by the FDA of January 2, 2025, for this submission. The vanza triple has not been approved by any global health authority. Long-Term Benefits of TRIKAFTA ® Vertex will present new data on TRIKAFTA ® from long-term (96 week and 192 week) studies in patients ages 2-11 years old that reinforce the sustained benefit seen in studies in older people with CF. Specifically, that early treatment with TRIKAFTA ® is associated with sustained improvements in lung function. These new data demonstrate that in these young children, TRIKAFTA ® could also lead to improved exocrine pancreatic function over time. The data presented at NACFC highlight the safety and tolerability of TRIKAFTA ® , which were generally consistent with the established safety profile. “ I have seen first-hand the positive long-term impact that improvement of CFTR function by TRIKAFTA can have on patients’ clinical outcomes. These improvements are particularly striking for me as a physician caring for young children, where improvements in things like lung function, pancreatic function and quality of life are so meaningful,” said Professor Marcus A. Mall, M.D., Professor and Chair of the Department of Pediatric Respiratory Medicine, Immunology and Critical Care Medicine and Cystic Fibrosis Center at Charité - Universitätsmedizin Berlin. Vertex will have four poster presentations that include clinical trial and real-world evidence data, three specifically on TRIKAFTA ® and one showing sustained benefits from KALYDECO ® , which is approved for treatment in the youngest ages. “ Long-term safety and efficacy of elexacaftor/tezacaftor/ivacaftor in children 2 years and older with cystic fibrosis and at least one F508del allele: 96-week results from an open-label extension study,” will be a poster presentation on Friday, September 27, at 12:15-1:15 p.m. EDT. “ Long-term safety and efficacy of elexacaftor/tezacaftor/ivacaftor in children 6 years and older with cystic fibrosis and at least one F508del allele: Results from a 192-week extension study,” will be a poster presentation on Friday, September 27, at 1:15-2:15 p.m. EDT. “ Effectiveness of elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) in people with cystic fibrosis and non-F508del CFTR variants: Interim results from a registry-based study,” will be a poster presentation on Friday, September 27, from 12:15-1:15 p.m. EDT. “ Long-term benefits of early ivacaftor (IVA) initiation in people with cystic fibrosis (CF),” will be a poster presentation on Friday, September 27, from 1:15-2:15 p.m. EDT. About Cystic Fibrosis Cystic fibrosis (CF) is a rare, life-shortening genetic disease affecting more than 92,000 people globally. CF is a progressive, multi-organ disease that affects the lungs, liver, pancreas, GI tract, sinuses, sweat glands and reproductive tract. CF is caused by a defective and/or missing CFTR protein resulting from certain mutations in the CFTR gene. Children must inherit two defective CFTR genes — one from each parent — to have CF, and these mutations can be identified by a genetic test. While there are many different types of CFTR mutations that can cause the disease, the vast majority of people with CF have at least one F508del mutation. CFTR mutations lead to CF by causing CFTR protein to be defective or by leading to a shortage or absence of CFTR protein at the cell surface. The defective function and/or absence of CFTR protein results in poor flow of salt and water into and out of the cells in a number of organs. In the lungs, this leads to the buildup of abnormally thick, sticky mucus, chronic lung infections and progressive lung damage that eventually leads to death for many patients. The median age of death is in the 30s, but with treatment, projected survival is improving. Learn more about the importance of sweat chloride (SwCl) in cystic fibrosis. Today Vertex CF medicines are treating over 68,000 people with CF across more than 60 countries on six continents. This represents 2/3 of the diagnosed people with CF eligible for CFTR modulator therapy. About vanzacaftor/tezacaftor/deutivacaftor (the “vanza triple”) In people with CF, mutations in the CFTR gene lead to decreased quantity and/or function of the CFTR protein channel at the cell surface. Vanzacaftor and tezacaftor are designed to increase the amount of CFTR protein at the cell surface by facilitating the processing and trafficking of the CFTR protein. Deutivacaftor is a potentiator designed to increase the channel open probability of the CFTR protein delivered to the cell surface to improve the flow of salt and water across the cell membrane. Investigational vanzacaftor/tezacaftor/deutivacaftor was granted Fast Track and Orphan Drug Designations from the U.S. Food and Drug Administration for the treatment of CF. The vanza triple will be subject to a meaningfully lower single-digit royalty obligation, compared to the rate payable on Vertex’s current CF portfolio. About TRIKAFTA ® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) In people with certain types of mutations in the CFTR gene, the CFTR protein is not processed or folded normally within the cell, and this can prevent the CFTR protein from reaching the cell surface and functioning properly. TRIKAFTA ® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is an oral medicine designed to increase the quantity and function of the CFTR protein at the cell surface. Elexacaftor and tezacaftor work together to increase the amount of mature protein at the cell surface. Ivacaftor, which is known as a CFTR potentiator, is designed to facilitate the ability of CFTR proteins to transport salt and water across the cell membrane. The combined actions of elexacaftor, tezacaftor and ivacaftor help hydrate and clear mucus from the airways. TRIKAFTA ® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients aged 2 years and older who have at least one copy of the F508del mutation, or another mutation responsive to TRIKAFTA ® , in the CFTR gene. Patients should talk to their doctor to learn if they have an indicated CF gene mutation. It is not known if TRIKAFTA ® is safe and effective in children under 2 years of age. TRIKAFTA U.S. INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR INDICATIONS AND USAGE TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients aged 2 years and older who have at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or another mutation that is responsive to treatment with TRIKAFTA. Patients should talk to their doctor to learn if they have an indicated CF gene mutation. It is not known if TRIKAFTA is safe and effective in children under 2 years of age. IMPORTANT SAFETY INFORMATION Before taking TRIKAFTA, patients should tell their doctor about all of their medical conditions, including if they: are allergic to TRIKAFTA or any ingredients in TRIKAFTA, have kidney problems, have or have had liver problems, are pregnant or plan to become pregnant because it is not known if TRIKAFTA will harm an unborn baby, or are breastfeeding or planning to breastfeed because it is not known if TRIKAFTA passes into breast milk. Patients should tell their doctor about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TRIKAFTA may affect the way other medicines work, and other medicines may affect how TRIKAFTA works. The dose of TRIKAFTA may need to be adjusted when taken with certain medicines. Patients should ask their doctor or pharmacist for a list of these medicines if they are not sure. Patients should especially tell their doctor if they take: antibiotics such as rifampin or rifabutin; seizure medicines such as phenobarbital, carbamazepine, or phenytoin; St. John’s wort; antifungal medicines including ketoconazole, itraconazole, posaconazole, voriconazole, or fluconazole; antibiotics including telithromycin, clarithromycin, or erythromycin. Patients should avoid food or drink that contains grapefruit while taking TRIKAFTA. TRIKAFTA can cause serious side effects, including: Liver damage and worsening of liver function in patients with severe liver disease that can be serious and may require transplantation. Liver damage has also happened in patients without liver disease. High liver enzymes in the blood , which is a common side effect in patients treated with TRIKAFTA . These can be serious and may be a sign of liver injury. The patient’s doctor will do blood tests to check their liver before they start TRIKAFTA, every 3 months during the first year of taking TRIKAFTA, and every year while taking TRIKAFTA. Patients should call their doctor right away if they have any of the following symptoms of liver problems: pain or discomfort in the upper right stomach (abdominal) area; yellowing of the skin or the white part of the eyes; loss of appetite; nausea or vomiting; dark, amber-colored urine. Serious allergic reactions have happened to patients who are treated with TRIKAFTA. Call your healthcare provider or go to the emergency room right away if you have any symptoms of an allergic reaction. Symptoms of an allergic reaction may include: rash or hives; tightness of the chest or throat or difficulty breathing; swelling of the face, lips and/or tongue; difficulty swallowing; and light-headedness or dizziness. Abnormality of the eye lens (cataract) has been noted in some children and adolescents treated with TRIKAFTA. If the patient is a child or adolescent, their doctor should perform eye examinations before and during treatment with TRIKAFTA to look for cataracts. The most common side effects of TRIKAFTA include headache, upper respiratory tract infection (common cold) including stuffy and runny nose, stomach (abdominal) pain, diarrhea, rash, increase in liver enzymes, increase in a certain blood enzyme called creatine phosphokinase, flu (influenza), inflamed sinuses, and increase in blood bilirubin. Patients should tell their doctor if they have any side effect that bothers them or that does not go away. These are not all the possible side effects of TRIKAFTA. For more information, patients should ask their doctor or pharmacist. Please click here to see the full U.S. Prescribing Information for TRIKAFTA. KALYDECO ® U.S. INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR INDICATIONS AND USAGE INDICATIONS AND USAGE KALYDECO (ivacaftor) is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 1 month and older who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to KALYDECO. Patients should talk to their doctor to learn if they have an indicated CF gene mutation. It is not known if KALYDECO is safe and effective in children under 1 month of age. IMPORTANT SAFETY INFORMATION Before taking KALYDECO, patients should tell their doctor about all their medical conditions, including if they : have liver or kidney problems; are allergic to KALYDECO or any ingredients; are pregnant or plan to become pregnant because it is not known if KALYDECO will harm an unborn baby; and are breastfeeding or planning to breastfeed because is not known if KALYDECO passes into breast milk. Patients should tell their doctor about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. KALYDECO may affect the way other medicines work , and other medicines may affect how KALYDECO works. Patients should ask their doctor or pharmacist for a list of these medicines if they are not sure. Patients should especially tell their doctor if they take the antibiotics rifampin or rifabutin; seizure medicines such as phenobarbital, carbamazepine, or phenytoin; St. John’s wort; antifungal medicines such as ketoconazole, itraconazole, posaconazole, voriconazole, or fluconazole; or antibiotics such as telithromycin, clarithromycin, or erythromycin. KALYDECO can cause dizziness in some patients who take it. If patients experience dizziness, they should not drive or operate machines until symptoms improve. Patients should avoid food or drink containing grapefruit while taking KALYDECO. KALYDECO can cause serious side effects including: High liver enzymes in the blood, which have happened in patients receiving KALYDECO . The patient’s doctor will do blood tests to check their liver before starting KALYDECO, every 3 months during the first year of taking KALYDECO, and every year while taking KALYDECO. For patients who have had high liver enzymes in the past, the doctor may do blood tests to check the liver more often. Patients should call their doctor right away if they have any of the following symptoms of liver problems: pain or discomfort in the upper right stomach (abdominal) area; yellowing of their skin or the white part of their eyes; loss of appetite; nausea or vomiting; or dark, amber-colored urine. Serious allergic reactions have happened to patients who are treated with KALYDECO. Patients should call their healthcare provider or go to the emergency room right away if they have symptoms of an allergic reaction. Symptoms of an allergic reaction may include rash or hives, tightness of the chest or throat or difficulty breathing, and light-headedness or dizziness. Abnormality of the eye lens (cataract), which has happened in some children and adolescents receiving KALYDECO. The patient’s doctor should perform eye examinations before and during treatment with KALYDECO to look for cataracts. The most common side effects include headache; upper respiratory tract infection (common cold), which includes sore throat, nasal or sinus congestion, and runny nose; stomach (abdominal) pain; diarrhea; rash; nausea; and dizziness. Use of KALYDECO in patients aged 1 month to less than 6 months born from a pregnancy lasting (gestational age) less than 37 weeks has not been evaluated. These are not all the possible side effects of KALYDECO. Please click here to see the full Prescribing Information for KALYDECO. About Vertex Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including acute and neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on LinkedIn , Facebook , Instagram , YouTube and Twitter/X . Special Note Regarding Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, the statements by Carmen Bozic, M.D., Professor Marcus A. Mall, M.D., and Claire L. Keating, M.D., in this press release, and statements regarding our expectations for and the anticipated benefits of the vanza triple, our expectations that medical presentations of Phase 3 data on the vanza triple will take place at NACFC, our expectations for the long-term data for TRIKAFTA, plans to present long-term TRIKAFTA data and KALYDECO data, and our expectations for a lower royalty obligation for the vanza triple. While we believe the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that data from the company's development programs may not support registration or further development of its compounds due to safety, efficacy, and other reasons, and other risks listed under the heading “Risk Factors” in Vertex's most recent annual report and subsequent quarterly reports filed with the Securities and Exchange Commission at www.sec.gov and available through the company's website at www.vrtx.com . You should not place undue reliance on these statements, or the scientific data presented. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available. (VRTX-GEN)

Phase 3Orphan DrugFast TrackDrug Approval

07 Jun 2024

·www.biospace.com

Vertex Presents New Data at the European Cystic Fibrosis Conference Demonstrating Significant Benefits of Treatment with TRIKAFTA®

Results from a randomized, placebo-controlled study of TRIKAFTA® in people with cystic fibrosis with rare, non-F508del CFTR mutations showed statistically significant and clinically meaningful improvements in the primary and all secondary endpoints Interim results of largest real-world study of TRIKAFTA® showed sustained improvement in lung function at three years as well as lower rates of lung transplant and death in people with cystic fibrosis, compared to pre-TRIKAFTA® initiation BOSTON--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that data on TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor), also known in the European Union and in the U.K. as KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor, were presented at this year’s European Cystic Fibrosis Society’s (ECFS) 47th European Cystic Fibrosis Conference held June 5-8, 2024, in Glasgow, Scotland. Data from a randomized, double-blind, Phase 3 study (abstract WS06.04) demonstrated that people with CF who have rare, non-F508del mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene responsive to TRIKAFTA® in vitro demonstrated clinical benefit from receiving TRIKAFTA®. Compared to placebo, lung function improved by 9.2 percentage points as measured by ppFEV1, CFTR function improved (as measured by mean sweat chloride concentration reductions of 28.3 mmol/L), and pulmonary exacerbations were reduced by 72% per year. Safety and tolerability were generally consistent with the established safety pro TRIKAFTA®. Vertex also presented the interim analysis (IA) of a registry-based study of real-world data collected from people with CF initiating TRIKAFTA® from 2019-20 in the U.S. and KAFTRIO® plus ivacaftor from 2020-21 in Germany (abstract WS01.04). The ongoing five-year post-authorization study is the largest real-world study of people with CF treated with TRIKAFTA®/KAFTRIO® to date, including more than 16,000 people with CF from the U.S. Cystic Fibrosis Foundation Patient Registry (CFFPR) and approximately 3,000 people with CF from the German CF Registry. The IA showed clinically meaningful, disease-modifying benefits for TRIKAFTA®/KAFTRIO®, including a 76% and 70% reduction in the cumulative annual rate of pulmonary exacerbations in the U.S. and in Germany, respectively, compared to the year prior to TRIKAFTA®/KATRIO® treatment. In addition, there was a 62% lower rate of death in the U.S. and 84% lower in Germany; and an 86% lower rate of lung transplant in the U.S. and 96% lower in Germany compared to the 2019 U.S. CFFPR and German CF Registry populations (pre-TRIKAFTA®/KAFTRIO®). No new safety concerns were identified. “The breadth of TRIKAFTA data presented at ECFS is further evidence of the significant potential of this disease-modifying medicine,” said Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer at Vertex. “These studies demonstrate that TRIKAFTA is changing the course of CF treatment and the lives of those living with CF.” Additional Presentations Other Vertex presentations at the conference this year include: Abstract WS15.02, entitled “Real-World Effectiveness of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in People With Cystic Fibrosis and ELX/TEZ/IVA-Responsive, Non-F508del CFTR Genotypes” Abstract EPS10.08, entitled “LONGITUDE: An Observational Study of the Long-term Effectiveness of ELX/TEZ/IVA in People With CF Using Data From the UK CF Registry – Preliminary Results From the Subgroup Aged 6-11 Years” Abstract P096, entitled “Qualitative Interviews Confirming the Faithful Electronic Migration of the Preschool Pictorial Cystic Fibrosis Questionnaire-Revised (CFQ-R) and Parent Preschool CFQ-R” Abstract EPS6.05, entitled “Clinical Outcomes in Concurrent Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) Treated vs. Ineligible Cohorts in the US Cystic Fibrosis Foundation Patient Registry (CFFPR) During COVID-19” Abstract P063, entitled “ELX/TEZ/IVA has beneficial effects on clinical outcomes and quality of life in people with cystic fibrosis in the real-world TRAJECTORY study” Abstract P072, entitled “Real-World Impact of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Italy: A Retrospective Study From a CF Center” About Cystic Fibrosis Cystic fibrosis (CF) is a rare, life-shortening genetic disease affecting more than 92,000 people globally. CF is a progressive, multi-organ disease that affects the lungs, liver, pancreas, GI tract, sinuses, sweat glands and reproductive tract. CF is caused by a defective and/or missing CFTR protein resulting from certain mutations in the CFTR gene. Children must inherit two defective CFTR genes — one from each parent — to have CF, and these mutations can be identified by a genetic test. While there are many different types of CFTR mutations that can cause the disease, the vast majority of people with CF have at least one F508del mutation. CFTR mutations lead to CF by causing CFTR protein to be defective or by leading to a shortage or absence of CFTR protein at the cell surface. The defective function and/or absence of CFTR protein results in poor flow of salt and water into and out of the cells in a number of organs. In the lungs, this leads to the buildup of abnormally thick, sticky mucus, chronic lung infections and progressive lung damage that eventually leads to death for many patients. The median age of death is in the 30s, but with treatment, projected survival is improving. Today Vertex CF medicines are treating over 65,000 people with CF across 60 countries on six continents. This represents 2/3 of the diagnosed people with CF eligible for CFTR modulator therapy. About TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) In people with certain types of mutations in the CFTR gene, the CFTR protein is not processed or folded normally within the cell, and this can prevent the CFTR protein from reaching the cell surface and functioning properly. TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is an oral medicine designed to increase the quantity and function of the CFTR protein at the cell surface. Elexacaftor and tezacaftor work together to increase the amount of mature protein at the cell surface. Ivacaftor, which is known as a CFTR potentiator, is designed to facilitate the ability of CFTR proteins to transport salt and water across the cell membrane. The combined actions of elexacaftor, tezacaftor and ivacaftor help hydrate and clear mucus from the airways. TRIKAFTA U.S. INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR INDICATIONS AND USAGE TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients aged 2 years and older who have at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or another mutation that is responsive to treatment with TRIKAFTA. Patients should talk to their doctor to learn if they have an indicated CF gene mutation. It is not known if TRIKAFTA is safe and effective in children under 2 years of age. IMPORTANT SAFETY INFORMATION Before taking TRIKAFTA, patients should tell their doctor about all of their medical conditions, including if they: are allergic to TRIKAFTA or any ingredients in TRIKAFTA, have kidney problems, have or have had liver problems, are pregnant or plan to become pregnant because it is not known if TRIKAFTA will harm an unborn baby, or are breastfeeding or planning to breastfeed because it is not known if TRIKAFTA passes into breast milk. Patients should tell their doctor about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TRIKAFTA may affect the way other medicines work, and other medicines may affect how TRIKAFTA works. The dose of TRIKAFTA may need to be adjusted when taken with certain medicines. Patients should ask their doctor or pharmacist for a list of these medicines if they are not sure. Patients should especially tell their doctor if they take: antibiotics such as rifampin or rifabutin; seizure medicines such as phenobarbital, carbamazepine, or phenytoin; St. John’s wort; antifungal medicines including ketoconazole, itraconazole, posaconazole, voriconazole, or fluconazole; antibiotics including telithromycin, clarithromycin, or erythromycin. Patients should avoid food or drink that contains grapefruit while taking TRIKAFTA. TRIKAFTA can cause serious side effects, including: Liver damage and worsening of liver function in patients with severe liver disease that can be serious and may require transplantation. Liver damage has also happened in patients without liver disease. High liver enzymes in the blood, which is a common side effect in patients treated with TRIKAFTA. These can be serious and may be a sign of liver injury. The patient’s doctor will do blood tests to check their liver before they start TRIKAFTA, every 3 months during the first year of taking TRIKAFTA, and every year while taking TRIKAFTA. Patients should call their doctor right away if they have any of the following symptoms of liver problems: pain or discomfort in the upper right stomach (abdominal) area; yellowing of the skin or the white part of the eyes; loss of appetite; nausea or vomiting; dark, amber-colored urine. Serious allergic reactions have happened to patients who are treated with TRIKAFTA. Call your healthcare provider or go to the emergency room right away if you have any symptoms of an allergic reaction. Symptoms of an allergic reaction may include: rash or hives; tightness of the chest or throat or difficulty breathing; swelling of the face, lips and/or tongue; difficulty swallowing; and light-headedness or dizziness. Abnormality of the eye lens (cataract) has been noted in some children and adolescents treated with TRIKAFTA. If the patient is a child or adolescent, their doctor should perform eye examinations before and during treatment with TRIKAFTA to look for cataracts. The most common side effects of TRIKAFTA include headache, upper respiratory tract infection (common cold) including stuffy and runny nose, stomach (abdominal) pain, diarrhea, rash, increase in liver enzymes, increase in a certain blood enzyme called creatine phosphokinase, flu (influenza), inflamed sinuses, and increase in blood bilirubin. Patients should tell their doctor if they have any side effect that bothers them or that does not go away. These are not all the possible side effects of TRIKAFTA. For more information, patients should ask their doctor or pharmacist. Please click here to see the full U.S. Prescribing Information for TRIKAFTA. About KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in Combination With Ivacaftor In people with certain types of mutations in the CFTR gene, the CFTR protein is not processed or folded normally within the cell, and this can prevent the CFTR protein from reaching the cell surface and functioning properly. KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor is an oral medicine designed to increase the quantity and function of the CFTR protein at the cell surface. Elexacaftor and tezacaftor work together to increase the amount of mature protein at the cell surface by binding to different sites on the CFTR protein. Ivacaftor, which is known as a CFTR potentiator, is designed to facilitate the ability of CFTR proteins to transport salt and water across the cell membrane. The combined actions of ivacaftor, tezacaftor and elexacaftor help hydrate and clear mucus from the airways. KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor is approved in the European Union and in the U.K. for the treatment of cystic fibrosis (CF) in patients aged 2 years and older who have at least one copy of the F508del mutation in the CFTR gene. For complete product information, please see the Summary of Product Characteristics that can be found on and on . About Vertex Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including acute and neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit or follow us on LinkedIn, Facebook, Instagram, YouTube and Twitter/X. Special Note Regarding Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements by Carmen Bozic, M.D. in this press release, and statements regarding our expectations for the benefits of TRIKAFTA/KAFTRIO. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that data from the company’s studies may not be indicative of final clinical trial results, that data from the company's development programs may not support registration or further development of its compounds due to safety, efficacy, or other reasons, that data may not be available on the anticipated timeline, or at all, that our development programs may experience delays, and other risks listed under the heading “Risk Factors” in Vertex's most recent annual report and subsequent filings filed with the Securities and Exchange Commission at and available through the company's website at . You should not place undue reliance on these statements or the scientific data presented. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available. (VRTX-GEN) View source version on businesswire.com: Contacts Vertex Pharmaceuticals Incorporated Investors: InvestorInfo@vrtx.com Media: mediainfo@vrtx.com or U.S.: 617-341-6992 or International: +44 20 3204 5275 Source: Vertex Pharmaceuticals Incorporated View this news release online at:

Clinical ResultPhase 3Drug Approval

29 May 2024

·www.biospace.com

Petros Pharmaceuticals Successfully Completes AI-Integrated Formative Human Factors Study Demonstrating Positive Interaction with Web App Designed for STENDRA(R) (avanafil) OTC Switch

Study paves the way toward a first-ever innovation program to include AI-optimization for FDA-guided Rx-to-OTC switch NEW YORK, NY / ACCESSWIRE / May 29, 2024 / Petros Pharmaceuticals, Inc. (NASDAQ:PTPI) ("Petros" or the "Company"), a company focused on expanding consumer access to medication through over-the-counter ("OTC") drug development programs, announces the successful completion of a Formative Human Factors study of its AI-integrated Web App, designed to facilitate OTC access of STENDRA® (avanafil) for consumers. This important development follows the Company's recent execution of an AI licensing agreement with a leading multi-billion dollar software provider announced earlier this year. The Web App (previously referred to as the "technology component") is an integral part of the Company's efforts to complete an Rx-to-OTC switch for STENDRA® (avanafil) under the guidance of the U.S. Food and Drug Administration. The study demonstrated a 90% or better error-free completion rate for nearly all 5,820 tasks assessed. The successful completion of the study paves the way for the Company to initiate the next stage of the evolving program, while continuing to optimize the AI component of the Web App. "The successful completion of the Human Factors Study and the positive outcomes we've seen to date continue to be encouraging signs of our progress in navigating the Rx-to-OTC switch for STENDRA® (avanafil). As we've previously indicated, we believe we have the potential to be first-in-class for the category with regards to OTC access," stated Fady Boctor, Petros' President and Chief Commercial Officer. "We continue to refine our program based on our regular interactions with the FDA, and the learnings from this study will allow us to continue to optimize the AI component of the Web App. Combined, we strongly believe in our approach and look forward to continuing development into the next indicated step for STENDRA® (avanafil) in a non-prescription setting." The Formative Human Factors study was conducted in a population of 30 consumers, including a cohort with limited literacy. The consumers were provided with five different use scenarios requiring correct demonstration of 194 different tasks using the Web App with no training or guidance. The study also included a proprietary AI interface that confirmed the identity of the consumer, a first-ever innovation for an Rx-to-OTC switch program. About Petros Pharmaceuticals Petros Pharmaceuticals, Inc. is committed to the goal of becoming a leading innovator in the emerging self-care market driving expanded access to key prescription pharmaceuticals as OTC treatment options. Currently, Petros is pursuing increased access for its flagship prescription ED therapy, STENDRA® (avanafil), via potential OTC designation. If ultimately approved by the FDA for OTC access, STENDRA® (avanafil) may be the first in its class to achieve this marketing status, also establishing company know how as a proven platform for other prospective prescription therapeutics. About the OTC Pathway The process of switching a prescription medication to OTC first involves the design of a Drug Facts Label ("DFL") that is well understood by potential consumers. Then, data must show that consumers can make an appropriate informed decision to use or not to use the product based only upon the information on the DFL and their personal medical history. Then consumers must demonstrate that they can properly use the product based upon the information on the DFL. To accomplish this, the FDA ordinarily requires a consumer tested OTC DFL. Such testing includes conduct of iterative Label Comprehension Studies (LCS) in the general population, Self-Selection Studies (SSS) in a population interested in using the product and in specific populations who may be harmed if they use the product, and usually one Actual Use Trial (AUT) demonstrating safe and appropriate use by consumers in a simulated OTC setting. The regulations that FDA is currently finalizing introduced Additional Conditions for Nonprescription Use (ACNU) criteria that enable correct self-selection by consumers and may expand OTC access to medications that formerly could only be available by prescription. An ACNU may be an innovative computerized tool, or the additional conditions may use other approaches that support the switch process. Important Safety Information about STENDRA® (avanafil) STENDRA® (avanafil), originally launched by Auxilium Pharmaceuticals prior to its sale to Endo Pharmaceuticals, is an oral phosphodiesterase 5 (PDE5) inhibitor for the treatment of erectile dysfunction. STENDRA® (avanafil) is not for use in women or children. It is not known if STENDRA® (avanafil) is safe and effective in women or children under 18 years of age. A 100-mg and 200-mg tablet can be taken as early as ~15 minutes before sexual activity. STENDRA® (avanafil) only works with sexual stimulation and should not be taken more than once a day. STENDRA can be taken with or without food; do not drink too much alcohol when taking STENDRA® (avanafil) (for example, more than three glasses of wine or three shots of whiskey) as it can increase chances of side effects. Of people enrolled in clinical trials, 1.4%, 2.0%, and 2.0%, respectively, stopped taking STENDRA® (avanafil) (50 mg, 100 mg, or 200 mg) due to side effects compared to 1.7% taking a placebo. STENDRA® (avanafil) was designed and developed expressly for erectile dysfunction. STENDRA is contraindicated for any form of organic nitrates, in patients with known hypersensitivity to any component of the tablet, and in patients who are using a guanylate cyclase stimulator. Patients should not use STENDRA if sexual activity is inadvisable due to cardiovascular status or any other reason. Before taking STENDRA, tell your doctor if you have had any kind of heart issues including heart attack, heart failure, angina and irregular heartbeat or have elevated or low blood pressure. Use of STENDRA with alpha-blockers, other antihypertensives, or substantial amounts of alcohol (greater than three units) may lead to hypotension. Patients should seek emergency treatment if an erection lasts greater than 4 hours. Patients should stop STENDRA and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of Non-Arteritic Ischemic Optic Neuropathy ("NAION"). Doctors should discuss with patients the increased risk of NAION in patients with a history of NAION. Patients should stop taking STENDRA and seek prompt medical attention in the event of sudden decrease or loss of hearing. STENDRA can potentiate the hypotensive effect of nitrates, alpha blockers, antihypertensives, and alcohol. CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, erythromycin) increase STENDRA exposure. For patients taking concomitant strong CYP3A4 inhibitors (including ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir and telithromycin), do not use STENDRA. Combination with Other PDE5 Inhibitors or Erectile Dysfunction Therapies is not recommended. The safety of STENDRA is unknown in patients with bleeding disorders and patients with active peptic ulceration. The use of STENDRA offers no protection against sexually transmitted diseases including HIV. Consider counseling patients on protective measures for sexually transmitted diseases. The most common adverse reactions reported with use of STENDRA include headache, flushing, nasal congestion, nasopharyngitis, and back pain. For more information about STENDRA, call 844-458-4887. If you would like to report an adverse event or product complaint, please contact us at 844-458-4887. You are encouraged to report negative side eﬀects of prescription drugs to the FDA by calling 1-800-FDA-1088, or at . Please see the full Prescribing Information and Patient Information. Cautionary Note Regarding Forward-Looking Statements This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are based upon Petros Pharmaceuticals, Inc.'s ("Petros," "we," "our," "us" or the "Company") management's assumptions, expectations, projections, intentions, and beliefs about future events. In some cases, predictive, future-tense or forward-looking words such as "intend," "develop," "goal," "plan," "predict", "may," "will," "project," "estimate," "anticipate," "believe," "expect," "continue," "potential," "opportunity," "forecast," "should," "target," "strategy" and similar expressions, whether in the negative or affirmative, that reflect our current views with respect to future events and operational, economic and financial performance are intended to identify forward-looking statements, but are not the exclusive means of identifying such statements. Such forward-looking statements are only predictions, and actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of risks and uncertainties, Petros' ability to execute on its business strategy, including its plans to develop and commercialize its product candidates; Petros' ability to comply with obligations as a public reporting company; Petros' ability to maintain compliance with the Nasdaq Stock Market's listing standards; risks related to Petros' ability to continue as a going concern; risks related to Petros' history of incurring significant losses; risks related to Petros' dependence on the commercialization of a single product, STENDRA®; and risks related to Petros' ability to obtain regulatory approvals for, or market acceptance of, any of its products or product candidates. Additional factors that could cause actual results to differ materially from the results anticipated in these forward-looking statements are contained in the Company's periodic reports and in other filings that the Company has or may file, with the U.S. Securities and Exchange Commission (the "SEC") under the headings "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere. The Company cautions readers that the forward-looking statements included in this press release represent our beliefs, expectations, estimates and assumptions only as of the date of hereof and are not intended to give any assurance as to future results. New factors emerge from time to time, and it is not possible for us to predict all these factors. Further, the Company cannot assess the effect of each such factor on our business or the extent to which any factor, or combination of factors, may cause actual results to be materially different from those contained in any forward-looking statement. Accordingly, you should not unduly rely on any forward-looking statements. The Company undertakes no obligation to update or revise any forward-looking statements contained in this press release, whether as a result of new information, future events, a change in our views or expectations or otherwise, except as required by federal securities laws. Contacts Investors: CORE IR ir@petrospharma.com Media: Jules Abraham CORE IR 917-885-7378 pr@coreir.com SOURCE: Petros Pharmaceuticals, Inc. View the original press release on accesswire.com

Drug Approval

100 Deals associated with Telithromycin

External Link

KEGG	Wiki	ATC	Drug Bank
D01078	Telithromycin	J01FA15	DB00976

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Acute bacterial sinusitis	US	Sanofi-Aventis U.S. LLC	01 Apr 2004
Infectious Diseases	US	Sanofi-Aventis U.S. LLC	01 Apr 2004
Acute sinusitis	EU	Aventis Pharma SARL	09 Jul 2001
Acute sinusitis	IS	Aventis Pharma SARL	09 Jul 2001
Acute sinusitis	LI	Aventis Pharma SARL	09 Jul 2001
Acute sinusitis	NO	Aventis Pharma SARL	09 Jul 2001
Bronchitis, Chronic	EU	Aventis Pharma SARL	09 Jul 2001
Bronchitis, Chronic	IS	Aventis Pharma SARL	09 Jul 2001
Bronchitis, Chronic	LI	Aventis Pharma SARL	09 Jul 2001
Bronchitis, Chronic	NO	Aventis Pharma SARL	09 Jul 2001
Community Acquired Pneumonia	EU	Aventis Pharma SARL	09 Jul 2001
Community Acquired Pneumonia	IS	Aventis Pharma SARL	09 Jul 2001
Community Acquired Pneumonia	LI	Aventis Pharma SARL	09 Jul 2001
Community Acquired Pneumonia	NO	Aventis Pharma SARL	09 Jul 2001
Pharyngitis	EU	Aventis Pharma SARL	09 Jul 2001
Pharyngitis	IS	Aventis Pharma SARL	09 Jul 2001
Pharyngitis	LI	Aventis Pharma SARL	09 Jul 2001
Pharyngitis	NO	Aventis Pharma SARL	09 Jul 2001
Tonsillitis	EU	Aventis Pharma SARL	09 Jul 2001
Tonsillitis	IS	Aventis Pharma SARL	09 Jul 2001

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Streptococcal Infections	Phase 3	US	Sanofi	01 Feb 2006
Streptococcal Infections	Phase 3	AR	Sanofi	01 Feb 2006
Streptococcal Infections	Phase 3	CL	Sanofi	01 Feb 2006
Streptococcal Infections	Phase 3	CR	Sanofi	01 Feb 2006
Otitis Media, Suppurative	Phase 3	US	Sanofi	01 Jan 2006
Otitis Media, Suppurative	Phase 3	AR	Sanofi	01 Jan 2006
Otitis Media, Suppurative	Phase 3	BR	Sanofi	01 Jan 2006
Otitis Media, Suppurative	Phase 3	CA	Sanofi	01 Jan 2006
Otitis Media, Suppurative	Phase 3	CL	Sanofi	01 Jan 2006
Otitis Media, Suppurative	Phase 3	CO	Sanofi	01 Jan 2006

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00273520 (Pubmed \| Br Dent J)	Phase 3	Acute asthma	278	Telithromycin	(iswkbcdlme) = kixcyadewa wosjbqbzwy (wypwdxsleq )	-	13 Apr 2006
				Placebo	(iswkbcdlme) = dnqvwlhiiv wosjbqbzwy (wypwdxsleq )
AAAAI2005	Not Applicable	Acute bacterial sinusitis	734	Telithromycin 800 mg once daily for 5 days	vkzsdjnqge(rwuperwmnb) = qvgfhmlpon ohizkahmlj (ytwlcetnif )	-	21 Mar 2005
				Comparator (Cefuroxime axetil 250 mg twice daily)	vkzsdjnqge(rwuperwmnb) = fmyynaysfa ohizkahmlj (ytwlcetnif )

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis