Drugs / Laninamivir
last change Feb 2023 re-read 9 days ago

Laninamivir

also known as INAVIR · R-125489

Small molecule

Developed for
influenza
Investigated by
University of Oxford

Trials 1

2024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2 NCT05648448 Feb 2023 → Jan 2027 expected influenza University of Oxford Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 5

DateIssuerRelease
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.

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as Laninamivir ClinicalTrials.gov intervention name — accepted as the source's own label NCT05648448 ↗
Known as INAVIR “Laninamivir (INAVIR®)” NCT05648448 ↗
Known as R-125489 ChEMBL registry synonym — accepted as the source's own label CHEMBL466246 ↗
Modality Small molecule — CHEMBL466246 ↗
Route Inhaled “Inhaled laninamivir” NCT05648448 ↗