Drugs / Laninamivir Octanoate
Laninamivir Octanoate
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Japan (PMDA) | — | influenza | 2010-02-01 | “Hovione is announcing the filing of a New Drug Application in Japan by its licensee Daiichi Sankyo Company Ltd. for the influenza drug CS-8958” hovione.com ↗ “has submitted a New Drug Application to the Ministry of Health, Labor and Welfare for approval in Japan of CS-8958” daiichisankyo.com ↗ |
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT02022761 | Oct 2013 | asthma | Biota Scientific Management Pty Ltd | Completed | No outcome recorded |
| Phase 1 | NCT00995826 | Apr → Sep 2009 | influenza | Biota Scientific Management Pty Ltd | Completed | No outcome recorded |
| Phase 1 | NCT00657111 | Apr 2008 → Oct 2009 | influenza | Biota Scientific Management Pty Ltd | Completed | No outcome recorded |
| Phase 1 | NCT00311714 | Apr → Dec 2007 | influenza | Biota Scientific Management Pty Ltd | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02014649 | Nov 2013 → Apr 2014 | influenza | Biota Scientific Management Pty Ltd | Terminated | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT00803595 | Nov 2008 → Mar 2009 | influenza | Daiichi Sankyo | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT01793883 Comparator | May 2013 → May 2014 | influenza | Biota Scientific Management Pty Ltd | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2016-08-26 | Daiichi Sankyo | Regulatory Daiichi Sankyo Receives Additional Dosage Regimen Approval in Japan for Long-acting Neuraminidase Inhibitor Inavir® Dry Powder Inhaler 20mg daiichisankyo.com ↗
These additional dosage regimen approvals make it possible to administer single inhalation doses of this drug to adults and children for the prevention of influenza virus infection. |
| 2013-12-20 | Daiichi Sankyo | Regulatory Daiichi Sankyo Receives Approval for the Use of Inavir® to Prevent Influenza daiichisankyo.com ↗
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo), announced today that it received approval in Japan to market Inavir® Dry Powder Inhaler 20mg (generic name: Laninamivir Octanoate Hydrate) for the prevention of influenza in both adults and children. |
| 2012-11-15 | Daiichi Sankyo | Regulatory Daiichi Sankyo Submits Application for Approval to Manufacture and Market Inavir(R) Dry Powder Inhaler, an Influenza Antiviral for the Prevention of Influenza in Japan daiichisankyo.com ↗
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo), announced today that it has submitted an application for a partial label change in Japan to manufacture and market the influenza antiviral product Inavir® Dry Powder Inhaler (laninamivir octanoate hydrate) for prevention of influenza infection. |
| 2012-08-22 | Daiichi Sankyo | Results Positive Phase 3 Clinical Study Results for Inavir(R) Dry Powder Inhaler, an Influenza Antiviral, for the Prevention of Influenza daiichisankyo.com ↗
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced today that the influenza antiviral product Inavir® Dry Powder Inhaler (laninamivir octanoate hydrate) significantly reduced the incidence of influenza infection compared to placebo in a phase 3 clinical study. |
| 2010-09-10 | Daiichi Sankyo | Regulatory Daiichi Sankyo Receives Approval to Manufacture and Market Inavir(R) Influenza Antiviral Inhalant for Treatment in Japan daiichisankyo.com ↗
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo), today announced that it has received approval in Japan to manufacture and market Inavir® Dry Powder Inhaler 20mg, for treatment of influenza that is a laninamivir octanoate hydrate prodrug. |
| 2010-02-02 | Hovione Scientia Limited | Regulatory Hovione’s TwinCaps® dry-powder inhaler filed in Japan for the treatment of influenza hovione.com ↗
Hovione is announcing the filing of a New Drug Application in Japan by its licensee Daiichi Sankyo Company Ltd. for the influenza drug CS-8958, which is delivered using Hovione’s TwinCaps® inhaler. |
| 2010-02-01 | Daiichi Sankyo | Regulatory Daiichi Sankyo Submits a New Drug Application in Japan for CS-8958, a Long-Acting Neuraminidase Inhibitor for the Treatment of Influenza daiichisankyo.com ↗
today announced that it has submitted a New Drug Application to the Ministry of Health, Labor and Welfare for approval in Japan of CS-8958, a proprietary anti-flu drug. |
| 2009-09-08 | Hovione Scientia Limited | Results Hovione’s TwinCaps® inhaler delivers successfully in Phase III clinical trials for influenza hovione.com ↗
In the Phase III trials conducted by Daiichi Sankyo, a single inhaled dose of CS-8958 was shown to be as effective as oseltamivir (TamifluⓇ) administered orally twice daily for 5 days (total of 10 doses). |
| 2009-08-10 | Daiichi Sankyo | Results Positive top line results from Phase III study (MARVEL) of anti-influenza virus agent 'CS-8958' daiichisankyo.com ↗
According to the results, non-inferiority to oseltamivir phosphate was confirmed in both the 20 mg group and 40 mg group of CS-8958 in terms of the primary endpoint, which was the time to alleviation of influenza illness. |
All press releases naming this drug 12 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Laninamivir octanoate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02022761 ↗ |
| Known as | CS-8958 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00803595 ↗ |
| Known as | Laninamivir octanoic acid ester | ChEMBL registry synonym — accepted as the source's own label CHEMBL467058 ↗ |
| Known as | R-118958 | ChEMBL registry synonym — accepted as the source's own label CHEMBL467058 ↗ |
| Modality | Small molecule | — CHEMBL467058 ↗ |
| Route | Inhaled | “single dose administered via inhalation” NCT00657111 ↗ |