A Post-Marketing Active Surveillance Of The FDC Of Fluticasone Furoate 100 or 200 mcg and Vilanterol Trifenatate 25mcg Dry Powder Inhaler Capsules In Patients With Asthma. - none

Start Date08 Nov 2024

Sponsor / Collaborator

Cipla Ltd.

CTRI/2024/08/073060 / Not yet recruitingPhase 4

A Multi-Centric, Active Post Marketing Surveillance Study to Assess the Safety and Efficacy of Fluticasone Furoate and Vilanterol Powder for Inhalation for the Treatment of Patients with Asthma - NIL

Start Date07 Sep 2024

Sponsor / Collaborator-

NCT06552364 / Not yet recruitingPhase 4IIT

Air Pollution and Inhaled Corticosteroids in COPD

Studies have shown that people with chronic obstructive pulmonary disease (COPD) have worse symptoms after breathing polluted air. People with COPD also often need to go to the hospital if they get a virus or other bug. One of the main drugs taken for COPD treatment (inhaled corticosteroid) may change COPD patients' lungs in ways that make it harder to deal with bugs, especially if they breathe in polluted air. If so, this could cause more frequent hospital visits. On the other hand, the same drug (inhaled corticosteroid) helps some people control symptoms, and may help them avoid hospital visits. The APEL investigators are conducting this study (APIC) to understand if this drug (inhaled corticosteroid), in combination with polluted air, will change the lungs of those with COPD in ways that make it more likely to catch bugs or have other problems.

Start Date01 Sep 2024

Sponsor / Collaborator

University of British Columbia

[+4]

100 Clinical Results associated with Fluticasone furoate

100 Translational Medicine associated with Fluticasone furoate

100 Patents (Medical) associated with Fluticasone furoate

545

Literatures (Medical) associated with Fluticasone furoate

01 Dec 2024·PULMONARY PHARMACOLOGY & THERAPEUTICS

Interaction between fluticasone furoate and umeclidinium in passively sensitized isolated human airways

Article

Author: Cazzola, Mario ; Rogliani, Paola ; Gallina, Filippo Tommaso ; Page, Clive P ; Rinaldi, Barbara ; Belardo, Carmela ; Matera, Maria Gabriella ; Facciolo, Francesco ; Calzetta, Luigino

Asthma management often includes inhaled corticosteroids (ICSs), with additional controllers like long-acting muscarinic antagonists (LAMAs) for severe cases. The primary goal of this study was to investigate the pharmacological interaction between various concentrations of fluticasone furoate (FF) and umeclidinium (UME) in isolated human airways to determine the nature of their interaction, whether synergistic or additive. Medium bronchi and small airways obtained from patients undergoing lobectomy were passively sensitized to mimic asthmatic conditions. The effects of FF and UME, alone and in combination, on airway relaxation were evaluated using histamine-induced contraction and electrical field stimulation. Pharmacological interactions were analyzed using the Bliss Independence theory. Results indicated that FF induced a partial, concentration-dependent relaxation of sensitized airways, while UME induced a larger relaxation in medium bronchi but a weaker effect in small airways. The combination of FF and UME resulted in significantly greater relaxation than either drug alone, demonstrating synergism at high concentrations in medium bronchi but only additive effects in small airways. This study suggests that higher doses of FF might be necessary in a fixed dose combination to achieve optimal synergistic bronchodilation with UME. Future research should focus on clinical trials to confirm these findings and explore the molecular mechanisms underlying these interactions, potentially improving personalized asthma therapy.

01 Dec 2024·ADVANCES IN THERAPY

Fluticasone Furoate/Umeclidinium/Vilanterol Initiation Following a COPD Exacerbation: Benefits of Prompt Initiation on COPD Outcomes

Article

Author: Laliberté, François ; Urosevic, Ana ; Paczkowski, Rosirene ; Mannino, David ; Noorduyn, Stephen G ; Germain, Guillaume ; DiRocco, Kristi

INTRODUCTION:

Previous real-world evidence suggests that prompt versus delayed initiation of single-inhaler triple therapy (SITT) with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) following an exacerbation results in improved clinical outcomes for patients with chronic obstructive pulmonary disease (COPD). This prior study was conducted in the first 2 years following FF/UMEC/VI approval, representing early trends. The current updated analysis aims to further elucidate the real-world evidence for FF/UMEC/VI.

METHODS:

This was a retrospective cohort study using the IQVIA PharMetrics^® Plus database. Patients with COPD initiating SITT with FF/UMEC/VI within 6 months of an exacerbation (index date) were classified as prompt (≤ 30 days following exacerbation) or delayed (31-180 days) initiators. The baseline period comprised the 12 months prior to index. Inverse probability of treatment weighting was used to balance differences in baseline characteristics between cohorts. COPD exacerbations, hospital readmission rates, and healthcare costs were compared between cohorts post-index.

RESULTS:

Overall, 5421 patients (prompt, 2057; delayed, 3364) were included. After weighting, baseline characteristics were well balanced between cohorts. For up to 12 months post-index, prompt initiators of FF/UMEC/VI had significantly lower rates of exacerbations per person-year versus delayed initiators (0.74 vs. 1.06; rate ratio 0.70, 95% confidence interval [CI] 0.64-0.77; P < 0.001). A 1-day delay in FF/UMEC/VI initiation was associated with a 0.31% increase in the rate of exacerbations. At 90 days post-index, Kaplan-Meier rates of all-cause (hazard ratio [HR] 0.62, 95% CI 0.45-0.86; P = 0.004) and COPD-related (HR 0.58, 95% CI 0.35-0.98; P = 0.042) hospital readmissions were significantly lower in the prompt versus delayed cohort. Total COPD-related healthcare costs per person per year were significantly lower for patients in the prompt versus delayed cohort.

CONCLUSION:

Healthcare providers should consider the positive impact of prompt FF/UMEC/VI initiation on exacerbation rate, hospital readmission rate, and costs when treating patients with COPD at risk of exacerbations.

01 Dec 2024·ADVANCES IN THERAPY

Characteristics of Patients with COPD Initiating Budesonide/Glycopyrronium/Formoterol or Other Triple Therapies in Japan: A Real-World Healthcare Claims Database Study (MITOS-AURA)

Article

Author: Yoshida, Yuri ; Argoubi, Ramzi ; Müllerová, Hana ; Makita, Naoyuki ; Takahashi, Koichiro ; Issa, Seham ; Castañeda-Sanabria, Johann ; Nowacki, Grégoire ; Matsumoto, Isao

INTRODUCTION:

In Japan, patients with chronic obstructive pulmonary disease (COPD) can be escalated to treatment with inhaled triple therapy. Two single-inhaler triple therapies combining an inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β₂-agonist (ICS/LAMA/LABA) are approved maintenance therapies for patients with COPD, and multiple-inhaler triple therapies (MITTs) are also available. There is limited evidence regarding real-life treatment patterns and characteristics of patients with COPD initiating triple therapies.

METHODS:

This observational, retrospective cohort study identified patients with COPD in Japan from an administrative claims database (May 2018-December 2021). Demographics, clinical characteristics, and healthcare resource utilization (HCRU) were assessed in four cohorts initiating a triple therapy: budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) early adopters (initiated ≤ 12 months after market approval [September 1, 2019]), contemporary BGF users (initiated > 12 months after market approval), fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) users, and any MITT users.

RESULTS:

A total of 636 patients were BGF early adopters, 2558 were contemporary BGF users, 11,187 used FF/UMEC/VI, and 5931 used MITT. The percentage of patients with concomitant asthma in each cohort was 73.0%, BGF early adopter; 74.2%, contemporary BGF; 75.7%, FF/UMEC/VI; and 84.5%, MITT. During the 12-month baseline period, the frequency of patients with ≥ 1 moderate/severe exacerbation was 18.2%, BGF early adopter; 14.3%, contemporary BGF; 13.1%, FF/UMEC/VI; and 14.0%, MITT. ICS/LABA treatment during baseline was the most frequent pathway to triple therapy, ranging from 38.2% to 51.7% across cohorts. HCRU was relatively high across cohorts (range of hospital outpatient visits/patient during the 12-month baseline period, 11.0-14.1). Multimorbidity was observed in > 80% of patients in all cohorts; cardiovascular diseases were among the most common.

CONCLUSION:

Many patients initiating triple therapy for COPD had concomitant asthma and had previously received ICS/LABA maintenance therapy. Patients prescribed BGF in the initial post-launch period were more likely to have a previous exacerbation history versus other cohorts, indicating more severe disease.

News (Medical) associated with Fluticasone furoate

01 Nov 2023

·www.biospace.com

Innoviva Reports Third Quarter 2023 Financial Results and Highlights Recent Company Progress

Received GSK royalties of $57.0 million and net product revenues of $13.7 million in the third quarter of 2023 Launched first-in-class therapy XACDURO® for treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter Announced positive topline Phase 3 zoliflodacin data for treatment of gonorrhea in November 2023 Repurchased $11.0 million of common stock BURLINGAME, Calif.--(BUSINESS WIRE)-- Innoviva Inc. (NASDAQ: INVA) (“Innoviva” or the “Company”), a diversified holding company with a portfolio of royalties and other healthcare assets, today reported financial results for the third quarter ended September 30, 2023, highlighted select corporate achievements and provided an overview of its key business initiatives. Gross royalty revenue from Glaxo Group Limited (“GSK”) for the third quarter 2023 was $57.0 million, which included royalties of $45.6 million from global net sales of RELVAR®/BREO® ELLIPTA® and royalties of $11.4 million from global net sales of ANORO® ELLIPTA® compared to $65.6 million for the third quarter of 2022, which included royalties of $55.7 million from global net sales of RELVAR®/BREO® ELLIPTA® and $9.9 million from global net sales of ANORO® ELLIPTA®, respectively. Net product sales and license revenue for the third quarter of 2023 was $13.7 million, which included $8.0 million from GIAPREZA® net sales, $5.1 million from XERAVA® net sales and $0.6 million from XACDURO® net sales. Net income was $82.0 million, or $1.26 basic per share, for the third quarter of 2023, compared to net income of $265.5 million, or $3.81 basic per share, for the third quarter of 2022; the decrease was primarily driven by non-repeated gain on sales of our subsidiary, Theravance Respiratory Company, and its TRELEGY® ELLIPTA® royalty stream in July 2022. Cash and cash equivalents totaled $180.0 million. Royalty, product sales and milestone receivables totaled $67.8 million as of September 30, 2023. "The third quarter of 2023 was marked by significant revenues stemming from our royalty portfolio and solid performance by our internal product portfolio,” said Pavel Raifeld, Chief Executive Officer of Innoviva. “A few weeks ago, we launched XACDURO® in the United States and are encouraged by the market receptivity. Moreover, we announced positive topline data from the Phase 3 trial of our lead pipeline asset, zoliflodacin, and are excited about its potential to affect the treatment paradigm for gonorrhea patients, especially in the presence of antimicrobial resistance concerns. These milestones reinforce the strength and promise of our infectious disease and critical care business.” Mr. Raifeld concluded, “We continued to exercise cost discipline and saw meaningful operational progress among our investees. In addition, we benefited from significant increases in the equity fair values of our investments. We are confident in the prospects of our business and plan to continue to pursue shareholder-friendly policies, such as share repurchases.” Third Quarter 2023 and Recent Highlights GSK Net Sales Third quarter 2023 net sales of RELVAR®/BREO® ELLIPTA® by GSK were $303.9 million with $109.5 million in net sales from the U.S. market and $194.4 million from non-U.S. markets. Third quarter 2023 net sales of ANORO® ELLIPTA® by GSK were $175.8 million with $89.2 million net sales from the U.S. market and $86.6 million from non-U.S. markets. Corporate Updates During the third quarter of 2023, Innoviva repurchased 856,750 shares of its outstanding common stock for $11.0 million. On July 10, 2023, Innoviva’s wholly owned subsidiary, Innoviva Strategic Opportunities, entered into a credit and security agreement with Armata Pharmaceuticals, Inc. (NYSE: ARMP) (“Armata”) and invested $25.0 million to advance Armata’s pipeline of therapeutic phage candidates and support the buildout of its state-of-the art cGMP manufacturing facility. On August 21, 2023, Innoviva appointed Stephen Basso as Chief Financial Officer. Clinical Updates In September 2023, Innoviva’s wholly owned subsidiary, Innoviva Specialty Therapeutics, launched XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use in patients 18 years of age and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter). XACDURO® is the first and only pathogen-targeted antibiotic and a significant advancement in the way healthcare professionals treat Acinetobacter. In November 2023, in collaboration with The Global Antibiotic Research & Development Partnership (GARDP), we announced that zoliflodacin, a first-in-class antibiotic, met its primary endpoint in a global pivotal phase 3 clinical trial for the treatment of uncomplicated gonorrhea, a prevalent disease affecting over 80 million patients a year globally with rapidly rising antimicrobial resistance concerns. Study investigators found that oral zoliflodacin demonstrated statistical non-inferiority of microbiological cure at the urogenital site when compared to treatment with intramuscular injection of ceftriaxone and oral azithromycin, a current global standard of care regimen. In the study, zoliflodacin demonstrated a favorable safety pro was generally well tolerated, with the majority of adverse events being mild-to-moderate. There were no discontinuations reported due to adverse events, serious adverse events, or deaths. About Innoviva Innoviva is a diversified holding company with a portfolio of royalties and other healthcare assets. Innoviva’s royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (“GSK”), including RELVAR®/BREO® ELLIPTA® (fluticasone furoate/ vilanterol, “FF/VI”) and ANORO® ELLIPTA® (umeclidinium bromide/ vilanterol, “UMEC/VI”). Under the Long-Acting Beta2 Agonist (“LABA”) Collaboration Agreement, 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 hospital 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 (Acinetobacter) 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. ANORO®, RELVAR® and BREO® are trademarks of the GSK group of companies. Forward Looking Statements This press release contains certain “forward-looking” statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, and future events. Innoviva intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. The words “anticipate”, “expect”, “goal”, “intend”, “objective”, “opportunity”, “plan”, “potential”, “target” and similar expressions are intended to identify such forward-looking statements. Such forward-looking statements involve substantial risks, uncertainties, and assumptions. These statements are based on the current estimates and assumptions of the management of Innoviva as of the date of this press release and are subject to known and unknown risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Innoviva to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: expected cost savings; lower than expected future royalty revenue from respiratory products partnered with GSK; the commercialization of RELVAR®/BREO® ELLIPTA®, ANORO® ELLIPTA®, GIAPREZA®, XERAVA® and XACDURO® in the jurisdictions in which these products have been approved; the strategies, plans and objectives of Innoviva (including Innoviva’s growth strategy and corporate development initiatives); the timing, manner, and amount of potential capital returns to shareholders; the status and timing of clinical studies, data analysis and communication of results; the potential benefits and mechanisms of action of product candidates; expectations for product candidates through development and commercialization; the timing of regulatory approval of product candidates; and projections of revenue, expenses and other financial items; the impact of the novel coronavirus (“COVID-19”); the timing, manner and amount of capital deployment, including potential capital returns to stockholders; and risks related to the Company’s growth strategy. Other risks affecting Innoviva are described under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained in Innoviva’s Annual Report on Form 10-K for the year ended December 31, 2022 and Quarterly Reports on Form 10-Q, which are on the Securities and Exchange Commission (“SEC”) and available on the SEC’s website at . Past performance is not necessarily indicative of future results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The information in this press release is provided only as of the date hereof, and Innoviva assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law. INNOVIVA, INC. Condensed Consolidated Statements of Income (in thousands, except per share data) (Unaudited) Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Revenue: Royalty revenue, net (1) $ 53,558 $ 62,150 $ 172,681 $ 260,429 Net product sales 13,701 5,107 40,942 5,107 License revenue - - 11,000 - Total revenue 67,259 67,257 224,623 265,536 Expenses: Cost of products sold (inclusive of amortization of inventory fair value adjustments, excluding depreciation and amortization of intangible assets) 10,182 3,680 27,910 3,680 Cost of license revenue - - 1,600 - Selling, general and administrative 28,636 27,810 71,913 46,084 Research and development 3,989 11,725 31,566 31,447 Amortization of acquired intangible assets 6,511 1,511 15,274 1,511 Gain on sale of Theravance Respiratory Company, LLC (“TRC”) - (266,696 ) - (266,696 ) Loss on debt extinguishment - - - 20,662 Changes in fair values of equity method investments, net (71,980 ) (10,298 ) (67,886 ) 44,475 Changes in fair values of equity and long-term investments, net 2,640 10,168 4,887 23,406 Interest and dividend income (4,114 ) (2,135 ) (11,032 ) (3,181 ) Interest expense 4,396 5,096 13,205 11,761 Other expense, net 1,047 (28 ) 4,289 750 Total expenses (18,693 ) (219,167 ) 91,726 (86,101 ) Income before income taxes 85,952 286,424 132,897 351,637 Income tax expense 3,906 57,077 14,706 63,061 Net income 82,046 229,347 118,191 288,576 Net income attributable to noncontrolling interest - (36,176 ) - 6,341 Net income attributable to Innoviva stockholders $ 82,046 $ 265,523 $ 118,191 $ 282,235 Basic net income per share attributable to Innoviva stockholders $ 1.26 $ 3.81 $ 1.79 $ 4.05 Diluted net income per share attributable to Innoviva stockholders $ 0.98 $ 2.80 $ 1.45 $ 3.07 Shares used to compute basic net income per share 64,953 69,731 66,016 69,640 Shares used to compute diluted net income per share 86,164 95,830 87,504 95,072 (1) Total net revenue is comprised of the following (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 (unaudited) (unaudited) Royalties $ 57,014 $ 65,606 $ 183,049 $ 270,797 Amortization of capitalized fees (3,456 ) (3,456 ) (10,368 ) (10,368 ) Royalty revenue, net $ 53,558 $ 62,150 $ 172,681 $ 260,429 INNOVIVA, INC. Condensed Consolidated Balance Sheets (in thousands) (unaudited) September 30, December 31, 2023 2022 Assets Cash and cash equivalents $ 179,997 $ 291,049 Royalty and product sale receivables 67,765 64,073 Inventory, net 40,515 55,897 Prepaid expense and other current assets 16,722 32,492 Property and equipment, net 361 170 Equity and long-term investments 529,531 403,013 Capitalized fees 87,239 97,607 Right-of-use assets 2,828 3,265 Goodwill 17,905 26,713 Intangible assets 236,845 252,919 Deferred tax assets 4,952 - Other assets 3,444 4,299 Total assets $ 1,188,104 $ 1,231,497 Liabilities and stockholders’ equity Other current liabilities $ 33,802 $ 32,322 Accrued interest payable 833 4,359 Deferred revenue 1,548 2,094 Convertible subordinated notes, due 2023, net - 96,193 Convertible senior notes, due 2025, net 191,115 190,583 Convertible senior notes, due 2028, net 254,603 253,597 Other long term liabilities 68,690 70,918 Deferred tax liabilities - 5,771 Income tax payable - long term 10,020 9,872 Innoviva stockholders’ equity 627,493 565,788 Total liabilities and stockholders’ equity $ 1,188,104 $ 1,231,497 INNOVIVA, INC. Cash Flows Summary (in thousands) (unaudited) Nine Months Ended September 30, 2023 2022 Net cash provided by operating activities $ 107,808 $ 192,827 Net cash used in investing activities (61,610 ) (47,956 ) Net cash used in financing activities (157,250 ) (45,567 ) Net change $ (111,052 ) $ 99,304 Cash and cash equivalents at beginning of period 291,049 201,525 Cash, cash equivalents and restricted cash at end of period $ 179,997 $ 300,829

Phase 3Executive ChangeClinical ResultFinancial StatementLicense out/in

11 Oct 2023

·www.biospace.com

Innoviva Specialty Therapeutics Presents New Data on its Critical Care Antibiotic Therapy Portfolio at Infectious Disease Week (IDWeek) 2023

Oral presentation highlights new findings about the efficacy of XACDURO® for the treatment of monomicrobial and polymicrobial Acinetobacter baumannii-calcoaceticus infections Researchers share global surveillance data on the in vitro activity of XERAVA® (eravacycline) for injection on resistant isolates and Gram-positive clinical pathogens Total of nine presentations on XACDURO® and XERAVA® to be revealed during IDWeek 2023 WALTHAM, Mass.--(BUSINESS WIRE)-- Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (Nasdaq: INVA), announced today plans to present an oral abstract and four poster sessions from their portfolio of U.S. Food and Drug Administration (FDA)-approved critical care and infectious disease therapies at IDWeek 2023, October 11-15, held in Boston, MA. The company will deliver one oral abstract presentation and two poster sessions highlighting findings on their newly approved therapy, XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use, which is the first and only antibiotic specifically developed to target the Acinetobacter pathogen in adults. XACDURO is indicated in adults for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex. In addition, four company-sponsored research studies on XACDURO will also be presented by the company’s research partners in poster sessions. “Antibiotic-resistant pathogens are one of the most significant and challenging threats to healthcare providers on the frontlines of infectious disease care,” said Margaret Koziel, MD, Chief Medical Officer, Innoviva Specialty Therapeutics. “IDWeek is an opportunity for us and for our research partners to share new clinical insights that help us better understand these therapies on a deeper level to improve treatment strategies.” Researchers from Innoviva Specialty Therapeutics will also present new surveillance data on XERAVA® (eravacycline), an anti-bacterial for the treatment of complicated intra-abdominal infections (cIAI) caused by multidrug-resistant bacteria during the scientific poster sessions. Company Presentations: Oral Abstract Presentation Efficacy of Sulbactam-Durlobactam (SUL-DUR) Compared to Colistin (COL) Against Acinetobacter baumannii-calcoaceticus Complex (ABC) Monomicrobial and Polymicrobial Infections in a Phase 3 Trial Authors: Alita A. Miller, Sarah M. McLeod, Adam Shapiro, Khurram Rana, David Altarac Innoviva Specialty Therapeutics, Waltham, MA, United States Session Date: Thursday, October 12, 2023; 10:30 – 10:45 AM ET Session Topic: Clinical Trials Session Location: 102 AB Poster Sessions Pharmacometric Analyses to Support Sulbactam-Durlobactam (SUL-DUR) Dosing Regimens in Patients with Altered Renal Function (2549) Authors: Kajal Larson, Sujata Bhavnani, Jeffrey Hammel, Anthony Cammarata, John O'Donnell, Christopher Rubino; Innoviva Specialty Therapeutics, Waltham, MA, United States, Institute for Clinical Pharmacodynamics, Inc. – Schenectady, NY United States Session Date: Saturday, October 14, 2023; 12:15 - 1:30 PM ET Session Topic: PK/PD Studies Session Location: Hall B + C In Vitro Susceptibility of Recent Clinical Isolates of P. aeruginosa and Enterobacterales to Imipenem or Meropenem Alone or in Combination with Sulbactam-Durlobactam (2138) Authors: Sarah M. McLeod, Nicole M. Carter, Samir H. Moussa, Alita A. Miller; Innoviva Specialty Therapeutics, Waltham, MA, United States Session Date: Saturday, October 14, 2023; 12:15 - 1:30 PM ET Session Topic: Antimicrobial Novel Agents Session Location: Hall B + C Surveillance of Eravacycline Against Enterobacterales and Non-Fermenter Clinical Isolates, Including Resistant Isolates, Collected Worldwide from Multiple Infection Sites During 2021 (2132) Authors: Stephen Hawser, Nimmi Kothari, Federica Monti, Tony Hodges, Kristie Zappas; IHMA Europe, Monthey (Valais), Switzerland; Innoviva Specialty Therapeutics, Inc, Waltham (MA), United States Session Date: Saturday, October 14, 2023; 12:15 – 1:30 PM ET Session Topic: Antimicrobial Novel Agents Session Location: Hall B + C Surveillance of Eravacycline Against Gram-Positive Clinical Pathogens, Including Resistant Isolates, Collected Worldwide From Multiple Infection Sites During 2021 (2133) Authors: Stephen Hawser, Nimmi Kothari, Federica Monti, Tony Hodges, Kristie Zappas; IHMA Europe, Monthey (Valais), Switzerland; Innoviva Specialty Therapeutics, Inc, Waltham (MA), United States Session Date: Saturday, October 14, 2023; 12:15 – 1:30 PM ET Session Topic: Antimicrobial Novel Agents Session Location: Hall B + C Company-Sponsored Research Presentations: Poster Sessions In vitro Synergy of the Combination of Sulbactam-Durlobactam and Cefepime at Clinically Relevant Concentrations Against A. baumannii, P. aeruginosa, and Enterobacterales (2121) Authors: Aliaa Fouad, PhD, David P. Nicolau, PharmD, FCCP, FIDSA, and Christian M. Gill, PharmD, Center for Anti-Infective Research and Development, Hartford Hospital, Hartford, CT, United States, Division of Infectious Diseases, Hartford Hospital, Hartford, CT United States Session Date: Saturday, October 14, 2023; 12:15 – 1:30 PM ET Session Topic: PK/PD Studies Session Location: Hall B + C Ex Vivo Assessment of Sulbactam-Durlobactam (SUL-DUR) Clearance During Continuous Renal Replacement Therapy (CRRT) (2526) Authors: Yasmeen Abouelhassan, Yuwei Shen, Xiaoyi Ye, David P Nicolau, Joseph L. Kuti Ctr. for Anti-Infect. Res. & Dev., Hartford Hospital, Hartford, CT Inpatient Hemo-Therapeutics, Hartford Hospital, Hartford, CT United States Session Date: Saturday, October 14, 2023; 12:15 – 1:30 PM ET Session Topic: New Antimicrobial Drug Development Session Location: Hall B + C (2515) Evaluation of the Equivalency of the Oxoid Sulbactam-Durlobactam (10/10µg) Antimicrobial Disc to the CLSI M07 Broth Microdilution Frozen Reference Method Authors: K. L. Hajek B.S., A.J Lovatt BSc., S. Bhalerao PhD., N. Khan BSc., D.T Staats M.S. M.M Hendrix B.S., N.M Holliday B.S., C.C Knapp M.S. Thermo Fisher Scientific, Cleveland, OH, United States; Thermo Fisher Scientific, Basingstoke, United Kingdom Session Date: Saturday, October 14, 2023; 12:15 – 1:30 PM Session Topic: New Antimicrobial Drug Development Session Location: Hall B + C (2517) Activity of Sulbactam-Durlobactam, Antibacterial Combinations, and Comparators Against a Challenge Set of 66 Acinetobacter Baumannii-Calcoaceticus Species Complex Isolates Authors: MD Huband, RE Mendes, G Bartleson, H Huynh, M Castanheira JMI Laboratories, North Liberty, IA, United States Session Date: Saturday, October 14, 2023; 12:15 – 1:30 PM Session Topic: New Antimicrobial Drug Development Session Location: Hall B + C About Acinetobacter Members of the Acinetobacter baumannii-calcoaceticus complex (Acinetobacter) are Gram-negative, opportunistic human pathogens that predominantly infect critically ill patients, often resulting in severe pneumonia and bloodstream infections.1 They can infect other body sites, such as the urinary tract and the skin.1 Acinetobacter is considered a global threat in the healthcare setting due in part to its ability to acquire multidrug resistance.2 Acinetobacter is resistant to penicillins and has also acquired resistance genes for almost all antibiotics used to treat Gram-negative bacteria, including fluoroquinolones, aminoglycosides, cephalosporins, and carbapenems.2 The Centers for Disease Control and Prevention (CDC) has identified carbapenem-resistant micro-organisms as an urgent threat.3 Globally, Acinetobacter baumannii was among the top six leading pathogens for deaths associated with resistance in 2019.4 Carbapenem-resistant Acinetobacter is considered a Priority 1 pathogen by the World Health Organization (WHO).5 In the U.S., there are more than 40,000 cases of Acinetobacter each year and approximately bout 40 percent of those are carbapenem-resistant.6,7 Globally, there are about a million cases each year of Acinetobacter, and about two-thirds of those are carbapenem-resistant Acinetobacter baumannii.6 More than 300,000 global deaths annually are associated with carbapenem-resistant Acinetobacter.4 About XACDURO® XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use, is a combination of sulbactam, a beta-lactam antibacterial, and durlobactam, a beta-lactamase inhibitor, approved in patients 18 years of age and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter). XACDURO is not indicated for the treatment of HABP/VABP caused by pathogens other than susceptible isolates of Acinetobacter. XACDURO® INDICATION & USAGE Indication XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use is indicated in adults for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii- calcoaceticus complex. Limitations of Use XACDURO is not indicated for the treatment of HABP/VABP caused by pathogens other than susceptible isolates of Acinetobacter baumannii-calcoaceticus complex. Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of XACDURO and other antibacterial drugs, XACDURO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. IMPORTANT SAFETY INFORMATION Contraindications: XACDURO is contraindicated in patients with a history of known severe hypersensitivity to the components of XACDURO or other beta-lactam antibacterial drugs. Warnings and Precautions: Hypersensitivity was observed in patients treated with XACDURO in clinical trials. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Before initiating therapy with XACDURO, careful inquiry should be made concerning previous hypersensitivity reactions to carbapenems, penicillins, cephalosporins, other beta lactams, and other allergens. If an allergic reaction occurs, discontinue XACDURO. Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs. If CDAD is suspected or confirmed, the risk/benefit of continuing treatment with XACDURO should be assessed. Prescribing XACDURO in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Adverse Reactions: The most common adverse reactions reported in >10% of patients treated with XACDURO were liver test abnormalities (19%), diarrhea (17%), anemia (13%), and hypokalemia (12%). To report SUSPECTED ADVERSE REACTIONS, contact Innoviva Specialty Therapeutics, Inc. at 1-800-651-3861 or FDA at 1-800-FDA-1088 or . Before administering, please see the Full Prescribing Information for XACDURO. XERAVA® Important Safety Information Indications and Usage XERAVA is indicated for the treatment of complicated intra-abdominal infections (cIAI) caused by susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii, Enterobacter cloacae, Klebsiella oxytoca, Enterococcus faecalis, Enterococcus faecium, Staphylococcus aureus, Streptococcus anginosus group, Clostridium perfringens, Bacteroides species, and Parabacteroides distasonis in patients 18 years or older. Limitations of Use XERAVA is not indicated for the treatment of complicated urinary tract infections (cUTI). Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of XERAVA and other antibacterial drugs, XERAVA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. XERAVA is contraindicated for use in patients with known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs, or to any of the excipients. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with XERAVA. The use of XERAVA during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia. The use of XERAVA during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, and may range in severity from mild diarrhea to fatal colitis. The most common adverse reactions observed in clinical trials (incidence ≥3%) were infusion site reactions (7.7%), nausea (6.5%), and vomiting (3.7%). XERAVA is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti-anabolic action which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with XERAVA. Discontinue XERAVA if any of these adverse reactions are suspected. To report SUSPECTED ADVERSE REACTIONS, contact Innoviva Specialty Therapeutics, Inc., at 1-833-7-XERAVA (1-833-793-7282) or FDA at 1-800-FDA-1088 or Please see Full Prescribing Information for XERAVA. About Innoviva Specialty Therapeutics Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc., is focused on delivering innovative therapies in critical care and infectious disease. Innoviva Specialty Therapeutics’ products, through its affiliate, La Jolla Pharmaceutical Company, include 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. Innoviva Specialty Therapeutics’ products, through its affiliate, Entasis Therapeutics Inc., include 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 (Acinetobacter). For more information about Innoviva Specialty Therapeutics, please visit here. About Innoviva Innoviva, Inc., is a diversified holding company with a portfolio of royalties and other healthcare assets, including Innoviva Specialty Therapeutics, a subsidiary focused on delivering innovative therapies in critical care and infectious disease. Innoviva’s royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (GSK), including RELVAR®/BREO® ELLIPTA® (fluticasone furoate/vilanterol, FF/VI) and ANORO® ELLIPTA® (umeclidinium bromide/vilanterol, UMEC/VI). Under the Long-Acting Beta2 Agonist (LABA) Collaboration Agreement, Innoviva is entitled to receive royalties from GSK on sales of RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®. ANORO®, RELVAR® and BREO® are trademarks of the GSK group of companies. For more information on Innoviva, please visit here. Forward Looking Statements This press release contains certain “forward-looking” statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, and future events. Innoviva intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. The words “anticipate”, “expect”, “goal”, “intend”, “objective”, “opportunity”, “plan”, “potential”, “target” and similar expressions are intended to identify such forward-looking statements. Such forward-looking statements involve substantial risks, uncertainties, and assumptions. These statements are based on the current estimates and assumptions of the management of Innoviva as of the date of this press release and are subject to known and unknown risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Innoviva to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: expected cost savings; lower than expected future royalty revenue from respiratory products partnered with GSK; the commercialization of RELVAR®/BREO® ELLIPTA®, ANORO® ELLIPTA® and, formerly, TRELEGY® ELLIPTA® in the jurisdictions in which these products have been approved; the strategies, plans and objectives of Innoviva (including Innoviva’s growth strategy and corporate development initiatives beyond the existing respiratory portfolio); the timing, manner, and amount of potential capital returns to shareholders; the status and timing of clinical studies, data analysis and communication of results; the potential benefits and mechanisms of action of product candidates; expectations for product candidates through development and commercialization; the timing of regulatory approval of product candidates; and projections of revenue, expenses and other financial items; the impact of the novel coronavirus (COVID-19). Other risks affecting Innoviva are described under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained in Innoviva’s Annual Report on Form 10-K for the year ended December 31, 2022 and Quarterly Reports on Form 10-Q, which are on the Securities and Exchange Commission (SEC) and available on the SEC’s website at . Past performance is not necessarily indicative of future results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The information in this press release is provided only as of the date hereof, and Innoviva assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law. References 1 Ballouz T, Aridi J, Afif C, et al. (2017) Risk Factors, Clinical Presentation, and Outcome of Acinetobacter baumannii Bacteremia. Front. Cell. Infect. Microbiol. 7:156. doi: 10.3389/fcimb.2017.00156 2 Kyriakidis I, Vasileiou E, Pana ZD, Tragiannidis A. Acinetobacter baumannii Antibiotic Resistance Mechanisms. Pathogens. 2021 Mar 19;10(3):373. doi: 10.3390/pathogens10030373. PMID: 33808905; PMCID: PMC8003822. 3 Centers for Disease Control and Prevention, “Carbapenem-resistant Acinetobacter baumannii (CRAB): An urgent public health threat in United States healthcare facilities,” August 2021: . Accessed: August 7, 2023 4 Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet. 2022; 399(10325):629-655. (21)02724-0/fulltext 5 World Health Organization, “WHO publishes list of bacteria for which new antibiotics are urgently needed,” February 27, 2017: . Accessed: August 7, 2023 6 Spellberg B, Rex JH. The Value of Single-Pathogen Antibacterial Agents. National Review Drug Discovery. 2013 Dec;12(12):963. doi: 10.1038/nrd3957-c1. Epub 2013 Nov 15. 7 Gupta V, Ye G, Olesky M, Lawrence K, Murray J, Yu K. National prevalence estimates for resistant Enterobacteriaceae and Acinetobacter species in hospitalized patients in the United States. Int J Infect Dis. 2019 Aug;85:203-211. doi: 10.1016/j.ijid.2019.06.017. Epub 2019 Jun 20. PMID: 31229615.

Phase 3Drug ApprovalLicense out/inQualified Infectious Disease Product

19 Sep 2023

·www.biospace.com

Innoviva to Participate in the Cantor Global Healthcare Conference

BURLINGAME, Calif.--(BUSINESS WIRE)--Innoviva Inc. (Nasdaq: INVA) (“Innoviva”), a diversified holding company with a portfolio of royalties and other healthcare assets, today announced that Pavel Raifeld, Chief Executive Officer, will participate in a fireside chat at the Cantor Global Healthcare Conference in New York, NY on Wednesday, September 27, 2023 at 1:50 p.m. Eastern Time. A live webcast of the fireside chat can be accessed under “Events & Presentations” in the Investor Relations section of the Company’s website at . The webcast will be available for replay for 90 days following the event. About Innoviva Innoviva, Inc., is a diversified holding company with a portfolio of royalties and other healthcare assets, including Innoviva Specialty Therapeutics, a subsidiary focused on delivering innovative therapies in critical care and infectious disease. Innoviva’s royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (GSK), including RELVAR®/BREO® ELLIPTA® (fluticasone furoate/vilanterol, FF/VI) and ANORO® ELLIPTA® (umeclidinium bromide/vilanterol, UMEC/VI). Under the Long-Acting Beta2 Agonist (LABA) Collaboration Agreement, Innoviva is entitled to receive royalties from GSK on sales of RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®. ANORO®, RELVAR® and BREO® are trademarks of the GSK group of companies. For more information on Innoviva, please visit here.

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KEGG	Wiki	ATC	Drug Bank
D06315	Fluticasone furoate	R03BA09 R01AD12	DB08906

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Asthma	US	Glaxosmithkline Intellectual Property Development Ltd.	20 Aug 2014
Pulmonary Disease, Chronic Obstructive	AU	GSK Plc	17 Apr 2014
Rhinitis, Allergic, Perennial	CA	GSK Plc	22 Oct 2007
Rhinitis, Allergic, Seasonal	CA	GSK Plc	22 Oct 2007
Rhinitis, Allergic	CN	Glaxo Wellcome UK Ltd.	16 Jun 2000

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Cardiovascular Diseases	Phase 3	US	GSK Plc	25 Jan 2011
Cardiovascular Diseases	Phase 3	CN	GSK Plc	25 Jan 2011
Cardiovascular Diseases	Phase 3	JP	GSK Plc	25 Jan 2011
Cardiovascular Diseases	Phase 3	AR	GSK Plc	25 Jan 2011
Cardiovascular Diseases	Phase 3	AU	GSK Plc	25 Jan 2011
Cardiovascular Diseases	Phase 3	AT	GSK Plc	25 Jan 2011
Cardiovascular Diseases	Phase 3	BY	GSK Plc	25 Jan 2011
Cardiovascular Diseases	Phase 3	BE	GSK Plc	25 Jan 2011
Cardiovascular Diseases	Phase 3	BA	GSK Plc	25 Jan 2011
Cardiovascular Diseases	Phase 3	BG	GSK Plc	25 Jan 2011

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AAAAI2024	Not Applicable	Rhinitis, Allergic, Perennial Maintenance	87	Fluticasone propionate/azelastine (FP/Aze 50/137 μg each nostril twice daily)	ncrtkfbelz(evocvlndon): mean difference = 1.26 (95% CI, 0.59 - 1.93), P-Value = <0.001	Positive	23 Feb 2024
				Fluticasone furoate (FF 55 μg each nostril once daily)
ATS2023	Not Applicable	-	-	Fluticasone Furoate/Vilanterol	elfvmezkru(qdaascauix) = Similar proportions of participants experienced ≥1 on-treatment adverse event (AE) in both populations (5-17 year-olds: n=181/454 [40%] receiving FF/VI versus n=163/448 [36%] receiving FF; 5-11 year-olds: n=133/337 [39%] receiving FF/VI versus n=122/336 [36%] receiving FF) mxixptubka (otdnixwnlj )	-	21 May 2023
NCT00521222 (ARGARG, CTgov)	Not Applicable	Asthma	90	Albuterol HFA+Ipratropium HFA+Fluticasone (Arg/Arg Genotype on Advair (Fluticasone With Salmeterol) HFA)	yoinipimry(lteopjcsit) = lwonfauaaz lynprektcq (fprfnagnqf, zplovzdsbt - ohdklgxprs) View more	-	21 Apr 2023
				Albuterol HFA+Ipratropium HFA+Fluticasone (Gly/Gly Genotype on Advair (Fluticasone With Salmeterol) HFA)	yoinipimry(lteopjcsit) = uvluobelgf lynprektcq (fprfnagnqf, nkynycsbap - taouglmmit) View more
NCT05736874 (CTgov)	Phase 3	COVID-19	1,407	Fluticasone (Arm C - Fluticasone)	cfqyawocmr(qsjmelmxsd) = aolkfrhloe kdhkepkflv (ozwxtydgzx, esywcldbdz - eezqslsxes) View more	-	12 Apr 2023
				Placebo (Arm C - Placebo)	cfqyawocmr(qsjmelmxsd) = sinkmpelpy kdhkepkflv (ozwxtydgzx, gedizvmidk - udkollutty) View more
NCT02889809 (114971, CTgov)	Phase 4	Asthma	477	Placebo+Montelukast	gxphhjbwjs(srmpkngokk) = raplzzzrnc zhhxaebpsm (qritlfkidb, xcfabjwexp - umxerxcnhj) View more	-	04 Jan 2022
NCT02180672 (SPARK, CTgov)	Phase 3	Sleep Apnea, Obstructive	211	Nasal Fluticasone (Nasal Steroids)	nehcsqmvje(bqnzwfmbgv) = ffgxgphqpo wblmfjmhxk (gqsbzywaqy, chgjxpvrvr - vaecrpfaax) View more	-	10 Mar 2021
				Placebo (Placebo)	nehcsqmvje(bqnzwfmbgv) = ktilduqtxo wblmfjmhxk (gqsbzywaqy, fkyifamits - euqkpcexrs) View more
NCT02164513 (IMPACT, Pubmed \| Am J Respir Crit Care Med)	Phase 3	Pulmonary Disease, Chronic Obstructive	-	Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25µg	wtklgpimtf(hudwfiwdvd): hazard ratio = 0.89 (95% CI, 0.67 - 1.16), P-Value = 0.387	Positive	15 Jun 2020
				Fluticasone Furoate/Vilanterol 100/25µg
NCT02991859 (GSK study 203162, ERS2019)	Phase 2	Asthma	54	Fluticasone furoate (FF)	vcbtmjuaqo(dafjxwevof) = ndohloljph tayoicxphm (aesujguwlj, 18 - 129)	-	28 Sep 2019
				Fluticasone propionate (FP)	vcbtmjuaqo(dafjxwevof) = znpfwyaxua tayoicxphm (aesujguwlj, 448 - 2610)
NCT02837380 (Pubmed \| Clin Pharmacol Drug Dev)	Phase 1	-	16	Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 µg	rsgtyiekeu(oxlxlsnehq) = glohibeoyd fpuoxhfmvd (rmbnpflglv ) View more	-	01 Aug 2019
NCT02666287 (Pubmed \| Clin Pharmacol Drug Dev)	Phase 1	-	48	BAT/FF	nqddzmxuhz(xxhbaztipg): P-Value = 0.79 View more	-	01 Feb 2019
				FF

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