Drugs / PERAMIVIR ANHYDROUS
PERAMIVIR ANHYDROUS
also known as
Peramivir · Alpivab · BCX-1812 · Peramivir hydrate · Peramivir trihydrate · Rapiacta · RAPIVAB · RWJ-270201 · +1 more
Regulatory milestones approvals, filings & regulatory actions · 10 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed influenza 6 milestones | |||||
| Filed | Japan (PMDA) | — | influenza | 2017-10-09 | “has filed a New Drug Application (NDA) in Japan to seek regulatory approval for intravenous (i.v.) peramivir to treat patients with influenza.” biocryst.com ↗ “filing of a New Drug Application (NDA) for i.v. peramivir in Japan” biocryst.com ↗ |
| Filed | EU (EMA) | — | influenza | 2017-10-09 | “announced today that the European Medicines Agency (EMA) has accepted the filing of its peramivir Marketing Authorization Application (MAA)” biocryst.com ↗ |
| Filed | US (FDA) | — | influenza | 2017-10-09 | “today announced that it has submitted a New Drug Application (NDA) filing for intravenous (i.v.) peramivir to the U.S. Food & Drug Administration (FDA).” biocryst.com ↗ |
| Filed | EU (EMA) | — | influenza | 2017-01-30 | “On January 30 , BioCryst announced that the European Medicines Agency (EMA) accepted the filing of its peramivir” biocryst.com ↗ |
| Filed | US (FDA) | — | influenza | 2013-12-20 | “the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for a pediatric indication of RAPIVAB” biocryst.com ↗ “the New Drug Application (NDA) for intravenous (i.v.) peramivir that was submitted to the FDA in December 2013” biocryst.com ↗ “In December, BioCryst submitted an NDA filing for i.v. peramivir to the U.S. Food & Drug Administration (FDA)” biocryst.com ↗ “Earlier this year, the i.v. peramivir New Drug Application (NDA) was accepted by the FDA” biocryst.com ↗ |
| Filed | Other | RAPIVAB | influenza | 2010-01-08 | “In January, BioCryst submitted a New Drug Submission (NDS) for RAPIVAB in Canada, seeking approval for the treatment of acute uncomplicated influenza in adult patients.” biocryst.com ↗ “Green Cross has filed a New Drug Application (NDA) in South Korea to seek regulatory approval for intravenous (i.v.) peramivir to treat patients with influenza.” biocryst.com ↗ “moksha8 has informed BioCryst that it has also filed for regulatory approval of peramivir in Brazil.” biocryst.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (2) | US (FDA) | RAPIVAB | — | 2017-09-20 – 2021-01-28 | fda.gov ↗ |
| Approved | EU (EMA) | Alpivab | — | 2018-04-13 | europa.eu ↗ |
| Approved | US (FDA) | RAPIVAB | — | 2014-12-19 | fda.gov ↗ |
Trials 15
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00297050 | Feb → Nov 2006 | influenza | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01063933 | ? → Aug 2011 | influenza | National Institute of Allergy and Infectious Diseases (NIAID) | Withdrawn | No outcome recorded |
| Phase 24 trials · 2 missed | ||||||
| Phase 2 | NCT05648448 | Feb 2023 → Jan 2027 expected | influenza | University of Oxford | Recruiting | No outcome recorded |
| Phase 2 | NCT00705406 | Jul 2008 → Apr 2009 | influenza | BioCryst Pharmaceuticals | Completed | Missed primary |
| Phase 2 | NCT00453999 | Jul 2007 → Sep 2008 | influenza | BioCryst Pharmaceuticals | Completed | Missed primary |
| Phase 2 | NCT00419263 | Jan → Sep 2007 | influenza | BioCryst Pharmaceuticals | Completed | No outcome recorded |
| Phase 38 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT07791251 | Oct 2026 → Apr 2028 expected | influenza | Capital Medical University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT02635724 | Dec 2015 → Apr 2018 | influenza | BioCryst Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02369159 | Mar 2015 → Oct 2019 | influenza | BioCryst Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01224795 | Oct → Nov 2010 | influenza | BioCryst Pharmaceuticals | Withdrawn | Met primary |
| Phase 3 | NCT00958776 | Nov 2009 → Nov 2012 | headache disorder, influenza, nasal cavity disorder, pharyngitis | BioCryst Pharmaceuticals | Terminated | Missed primary |
| Phase 3 | NCT00957996 | Oct 2009 → Oct 2010 | headache disorder, influenza, nasal cavity disorder, pharyngitis | BioCryst Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00610935 | Jan → Feb 2008 | influenza | BioCryst Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT00486980 | — | influenza | BioCryst Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT02609399 | Nov 2015 → May 2017 | influenza | Johns Hopkins University | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2/3 | NCT02665351 Comparator | Feb 2011 → Mar 2014 | influenza | Chinese University of Hong Kong | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 40
| Date | Issuer | Release |
|---|---|---|
| 2021-02-03 | BioCryst Pharmaceuticals | Regulatory BioCryst Announces FDA Approval of Supplemental New Drug Application for RAPIVAB® Expanding Patient Population to Include Children Six Months and Older biocryst.com ↗
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application for RAPIVAB ® (peramivir injection) expanding the patient population of RAPIVAB for the treatment of acute uncomplicated influenza to include patients six months and older who have been symptomatic for no more than two days. |
| 2018-05-01 | BioCryst Pharmaceuticals | Regulatory BioCryst Receives European Medicines Agency Approval for ALPIVAB™ for the Treatment of Influenza biocryst.com ↗
BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX), a pharmaceutical company focused on the development and commercialization of treatments for rare diseases, today announced that the European Medicines Agency (EMA) has approved peramivir with the brand name of ALPIVAB, a single intravenous (I.V.) infusion for the treatment of uncomplicated influenza in adults and children from the age of 2 years. |
| 2017-10-09 | BioCryst Pharmaceuticals | Results ST. JUDE STUDY SHOWS EFFECTIVENESS OF PERAMIVIR IN PREVENTION OF MORTALITY IN MOUSE MODEL OF AVIAN INFLUENZA H5N1 VIRUS INFECTION biocryst.com ↗
A survival rate of 40% to 60% was observed in mice treated with one or two injections of peramivir; however, 100% survival of mice was achieved by two injections of peramivir on the first day followed by once-daily administration for 7 days. |
| 2017-10-09 | BioCryst Pharmaceuticals | Regulatory Emergency Use Authorization Granted For BioCryst's Peramivir biocryst.com ↗
today announced that the U.S. Food and Drug Administration (FDA), in response to a request from the U.S. Centers for Disease Control and Prevention (CDC), has issued an emergency use authorization (EUA) for the investigational anti-viral drug intravenous (i.v.) peramivir |
| 2017-10-09 | BioCryst Pharmaceuticals | Results Data from Phase 2 Study of Peramivir in Patients Hospitalized with Influenza Presented at the XI International Symposium on Respiratory Viral Infections biocryst.com ↗
As reported in October 2008, there were no statistically significant differences in any of the efficacy endpoints between the three treatment arms, and peramivir was generally safe and well-tolerated at these dose levels. |
| 2017-10-09 | BioCryst Pharmaceuticals | Regulatory BioCryst's RAPIVAB(TM) (peramivir injection) Receives FDA Approval for the Treatment of Acute Uncomplicated Influenza biocryst.com ↗
BioCryst Pharmaceuticals, Inc. , (Nasdaq:BCRX) a pharmaceutical company focused on the development and commercialization of treatments for rare and infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved RAPIVAB (peramivir injection), an intravenous (i.v.) neuraminidase inhibitor for the treatment of acute uncomplicated influenza in patients 18 years and older who have been symptomatic for no more than two days. |
| 2017-10-09 | BioCryst Pharmaceuticals | Regulatory BioCryst's RAPIVAB® (peramivir injection) Receives FDA Approval for a Pediatric Indication biocryst.com ↗ |
| 2017-10-09 | BioCryst Pharmaceuticals | Regulatory BioCryst's Partner Shionogi Receives Marketing & Manufacturing Approval For Peramivir in Japan biocryst.com ↗
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that its partner, Shionogi & Co., Ltd. has received marketing and manufacturing approval for intravenous (i.v.) peramivir to treat patients with influenza in Japan. |
| 2017-10-09 | BioCryst Pharmaceuticals | Regulatory BioCryst's Partner Shionogi Receives Approval for Pediatric Use Of Peramivir in Japan biocryst.com ↗
BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that its partner, Shionogi & Co., Ltd. has received approval for an additional indication for use of intravenous (i.v.) peramivir to treat children and infants with influenza in Japan. |
| 2017-10-09 | BioCryst Pharmaceuticals | Regulatory BioCryst's Partner Shionogi Files for Peramivir Regulatory Approval in Japan biocryst.com ↗
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that its partner, Shionogi & Co., Ltd. has filed a New Drug Application (NDA) in Japan to seek regulatory approval for intravenous (i.v.) peramivir to treat patients with influenza. |
| 2017-10-09 | BioCryst Pharmaceuticals | Regulatory BioCryst's Partner Green Cross Receives Marketing & Manufacturing Approval for Peramivir in South Korea biocryst.com ↗
We are pleased that intravenous peramivir is now approved in Korea and represents the second country this year to make this important treatment option available for patients suffering from seasonal influenza. |
| 2017-10-09 | BioCryst Pharmaceuticals | Regulatory BioCryst's Partner Green Cross Files for Peramivir Regulatory Approval in South Korea biocryst.com ↗
"Green Cross has rapidly prepared their regulatory filing, the second application of what we hope will be many for marketing approvals of peramivir," said Jon P. Stonehouse, President and Chief Executive Officer of BioCryst. |
| 2017-10-09 | BioCryst Pharmaceuticals | Results BIOCRYST UPDATES PERAMIVIR CLINICAL DEVELOPMENT PLAN biocryst.com ↗
Preliminary analysis of the virologic data from the Phase II trial indicated that i.m. peramivir demonstrated statistically significant reductions in influenza virus shedding in both active treatment groups when compared to placebo, with greater reductions in the 300mg group (p<0.001). |
| 2017-10-09 | BioCryst Pharmaceuticals | Results BioCryst Reports Results From the First-Ever Completed Active-Controlled Phase 2 Study in Hospitalized Influenza biocryst.com ↗
There were no statistically significant differences in any of the efficacy endpoints between the three treatment arms. |
| 2017-10-09 | BioCryst Pharmaceuticals | Results BIOCRYST REPORTS PRELIMINARY RESULTS FROM A PHASE II CLINICAL TRIAL OF PERAMIVIR IN SUBJECTS WITH ACUTE INFLUENZA biocryst.com ↗
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced preliminary findings from a Phase II study with intramuscular (i.m.) injection of peramivir, the Company's product candidate for the treatment of seasonal and life-threatening influenza. |
| 2017-10-09 | BioCryst Pharmaceuticals | Results BioCryst Reports Positive Results From a Phase 2 Study of Intravenous Peramivir for Outpatient Influenza biocryst.com ↗
A Single Dose of Peramivir is Effective and Well-Tolerated at Both 300 mg and 600 mg Dose Levels. |
| 2017-10-09 | BioCryst Pharmaceuticals | Results BioCryst Reports Positive Preliminary Results of a Shionogi & Co., Ltd. Sponsored Phase II Study of I.V. Peramivir for the Treatment of Influenza in the Outpatient Setting biocryst.com ↗
The trial, conducted by BioCryst's partner, Shionogi & Co., Ltd. in Japan, met its primary endpoint of improvement in the median time to alleviation of symptoms in subjects with confirmed, acute, uncomplicated influenza infection, compared to placebo alone. |
| 2017-10-09 | BioCryst Pharmaceuticals | Regulatory BioCryst Receives Health Canada Approval for RAPIVAB® for the Treatment of Influenza biocryst.com ↗
today announced that Health Canada has approved RAPIVAB ® (peramivir injection), an intravenous (I.V.) treatment for acute, uncomplicated influenza. |
| 2017-10-09 | BioCryst Pharmaceuticals | Regulatory BIOCRYST RECEIVES FDA FAST TRACK DESIGNATION FOR PERAMIVIR biocryst.com ↗
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the U.S. Food and Drug Administration (FDA) has granted "fast track" designation for peramivir injection in the treatment of influenza infections, including highly virulent, life-threatening strains of influenza. |
| 2017-10-09 | BioCryst Pharmaceuticals | Results BIOCRYST PRESENTS PHASE I PERAMIVIR DATA AT THE OPTIONS FOR THE CONTROL OF INFLUENZA CONFERENCE biocryst.com ↗
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) presented results from two Phase I clinical studies of an intramuscular (i.m.) formulation of peramivir at the Options for the Control of Influenza Conference in Toronto, Ontario, Canada. |
| 2017-10-09 | BioCryst Pharmaceuticals | Results BioCryst to Present Peramivir Data at the 50th Annual ICAAC Meeting biocryst.com ↗
Intravenous Peramivir was not Associated with Repolarization Abnormalities in a Thorough QT/QTc Electrocardiographic Study |
| 2017-10-09 | BioCryst Pharmaceuticals | Results BioCryst To Present New Peramivir Data at the 51st Annual ICAAC Meeting biocryst.com ↗
The oral presentation "Safety and Anti-viral Effect of Multi-Day Therapy with IV Peramivir 300 mg BID or 600 mg QD in Hospitalized Influenza Subjects" (Presentation Number V-402) concludes that the two regimens studied were generally safe and well-tolerated in patients hospitalized with influenza. |
| 2017-10-09 | BioCryst Pharmaceuticals | Results BioCryst to Present New Clinical & Virologic Data for I.V. Peramivir at the 48th Annual IDSA Meeting biocryst.com ↗
However, in the sub-group of influenza B infected patients (N=32), peramivir treatment resulted in significantly faster reduction of viral replication and showed a trend to more rapid normalization of clinical outcomes compared to oral oseltamivir treatment. |
| 2017-10-09 | BioCryst Pharmaceuticals | Results BIOCRYST TO PRESENT LATE-BREAKER DATA ON ACTIVITY OF PERAMIVIR AT THE 46TH INTERSCIENCE CONFERENCE ON ANTIMICROBIAL AGENTS AND CHEMOTHERAPY (ICAAC) biocryst.com ↗
These are the first data to be presented describing the activity of peramivir in an established animal model using this highly pathogenic strain of H5N1. |
| 2017-10-09 | BioCryst Pharmaceuticals | Results BioCryst Pharmaceuticals Reports Positive Results of Shionogi & Co. Sponsored Phase 3 Studies of i.v. Peramivir for Influenza biocryst.com ↗
Both the 300 mg and 600 mg single dose peramivir groups demonstrated non-inferiority for the primary endpoint, time to alleviation of symptoms (TTAS), compared to the oseltamivir group. |
| 2017-10-09 | BioCryst Pharmaceuticals | Results BIOCRYST PHARMACEUTICALS, INC. ANNOUNCES PRELIMINARY PHASE III TRIAL RESULTS FOR INFLUENZA NEURAMINIDASE INHIBITOR, PERAMIVIR biocryst.com ↗
Peramivir was well tolerated at both doses studied. |
| 2017-10-09 | BioCryst Pharmaceuticals | Regulatory BioCryst Files Peramivir NDA for the Treatment of Influenza biocryst.com ↗
has submitted a New Drug Application (NDA) filing for intravenous (i.v.) peramivir to the U.S. Food & Drug Administration (FDA). |
| 2017-10-09 | BioCryst Pharmaceuticals | Regulatory BIOCRYST FILES IND APPLICATION FOR INJECTABLE PERAMIVIR biocryst.com ↗
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) has submitted an Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) for injectable formulations of peramivir, the company's influenza neuraminidase inhibitor. |
| 2017-10-09 | BioCryst Pharmaceuticals | Regulatory BioCryst Clarifies Government Declaration Regarding Peramivir biocryst.com ↗
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the Office of the Secretary, Department of Health & Human Services (HHS) has issued "HHS Secretary's Declaration for the Use of the Public Readiness and Emergency Preparedness Act for the Influenza Antiviral Peramivir." |
| 2017-10-09 | BioCryst Pharmaceuticals | Results BioCryst Announces RAPIVAB(TM) Trial Results for the Treatment of Influenza at the ICAAC 2014 Meeting biocryst.com ↗
The median time to alleviation of influenza symptoms after treatment with peramivir 300 mg was 113.2 hours, compared to 134.8 hours for placebo (p=0.161 adjusted for smoking behavior, influenza season and virus type, p=0.047 unadjusted). |
| 2017-10-09 | BioCryst Pharmaceuticals | Results BioCryst Announces RAPIVAB® (peramivir injection) and Galidesivir Presentations at IDWeek 2017™ biocryst.com ↗
Treatment-emergent adverse events possibly, probably or definitely related to study drug were reported in 9% of peramivir treated subjects vs 17% of oseltamivir treated subjects. |
| 2017-10-09 | BioCryst Pharmaceuticals | Regulatory BioCryst Announces RAPIVAB® Pediatric sNDA Acceptance biocryst.com ↗
BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for a pediatric indication of RAPIVAB ® (peramivir injection), which was submitted in March 2017 . |
| 2017-10-09 | BioCryst Pharmaceuticals | Results BIOCRYST ANNOUNCES PRESENTATION OF PERAMIVIR HUMAN CLINICAL DATA AT THE 46TH ANNUAL ICAAC MEETING biocryst.com ↗
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today reported positive results from several Phase I safety and pharmacokinetic studies with the neuraminidase inhibitor, peramivir, in development for the treatment of seasonal and life-threatening influenza. |
| 2017-10-09 | BioCryst Pharmaceuticals | Results BIOCRYST ANNOUNCES PRESENTATION OF DATA SUPPORTING DEVELOPMENT OF PERAMIVIR FOR SEASONAL AND LIFE-THREATENING INFLUENZA biocryst.com ↗
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today reported positive results from human clinical studies of the influenza neuraminidase inhibitor, peramivir being developed for the treatment of seasonal and life-threatening influenza, including avian flu. |
| 2017-10-09 | BioCryst Pharmaceuticals | Results BioCryst Announces Peramivir Phase 3 Safety & Virology Study Results and Provides a Clinical Program Update biocryst.com ↗
BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced top-line results from one of its two Phase 3 studies of intravenous (i.v.) peramivir for the treatment of patients hospitalized with influenza, and provided an update regarding its peramivir program. |
| 2017-10-09 | BioCryst Pharmaceuticals | Regulatory BioCryst Announces Peramivir NDA Acceptance by the FDA biocryst.com ↗
We are pleased that BioCryst's first NDA filing has been accepted by the FDA. |
| 2017-10-09 | BioCryst Pharmaceuticals | Results BioCryst Announces Outcome from the Peramivir Phase 3 Interim Analysis biocryst.com ↗
Based on this information, the independent data monitoring committee (DMC) recommended that the study be terminated for futility. |
| 2017-10-09 | BioCryst Pharmaceuticals | Regulatory BIOCRYST ANNOUNCES FDA APPROVAL TO INITIATE HUMAN TESTING OF INTRAVENOUS PERAMIVIR biocryst.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has given verbal approval to begin studies with intravenous peramivir, the company's influenza neuraminidase inhibitor. |
| 2017-10-09 | BioCryst Pharmaceuticals | Regulatory BioCryst Announces the Acceptance of Peramivir MAA Filing by the European Medicines Agency biocryst.com ↗
BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX), a pharmaceutical company focused on the development and commercialization of treatments for rare diseases, announced today that the European Medicines Agency (EMA) has accepted the filing of its peramivir Marketing Authorization Application (MAA) for treatment of symptoms typical of influenza in adults 18 years and older. |
| 2017-10-09 | BioCryst Pharmaceuticals | Regulatory BioCryst and moksha8 Announce Approval for the Importation & Use of peramivir in Mexico biocryst.com ↗
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that moksha8 has been granted approval from COFEPRIS (The Federal Commission for the Protection against Sanitary Risk) in Mexico for the importation and use of peramivir in patients with influenza associated with the 2009 H1N1 influenza A strain. |
All press releases naming this drug 73 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 17 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PERAMIVIR ANHYDROUS | ChEMBL registry synonym — accepted as the source's own label CHEMBL139367 ↗ |
| Known as | Alpivab | ChEMBL registry synonym — accepted as the source's own label CHEMBL139367 ↗ |
| Known as | BCX-1812 | “Peramivir (BCX-1812) 600 mg, administered intravenously” NCT00958776 ↗ |
| Known as | Peramivir | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02665351 ↗ |
| Known as | Peramivir hydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL139367 ↗ |
| Known as | Peramivir trihydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL139367 ↗ |
| Known as | Rapiacta | ChEMBL registry synonym — accepted as the source's own label CHEMBL139367 ↗ |
| Known as | RAPIVAB | “Peramivir (RAPIVAB®)” NCT05648448 ↗ |
| Known as | RWJ-270201 | ChEMBL registry synonym — accepted as the source's own label CHEMBL139367 ↗ |
| Known as | RWJ-270201-162 ANHYDROUS | ChEMBL registry synonym — accepted as the source's own label CHEMBL139367 ↗ |
| Action | Inhibit | “intravenous peramivir, a neuraminidase inhibitor” NCT00297050 ↗ |
| Modality | Small molecule | — CHEMBL139367 ↗ |
| Route | Intravenous | “intravenous peramivir” NCT00297050 ↗ |