Aloxi

(palonosetron hydrochloride injection)

AAvyxa

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Timeline

Expected Milestones

Q4 2026

Phase 1Not yet recruiting

Chemotherapy-Induced Nausea and Vomiting (CINV)

NCT07817004

Clinical

Trials by Indication[1]

Chemotherapy-Induced Nausea and Vomiting (CINV)1 trial

QLM2010 Comparative Pharmacokinetic Study With 2-Minute Intravenous Administration

Not yet recruiting·QQilu Pharmaceutical (Hainan) Co., Ltd.·Phase 1·NCT07817004·42 enrolled

Regulatory

FDA Approval Timeline[3]

Feb 29, 2008

ALOXI

NDA NDA021372

Aug 22, 2008

ALOXI

NDA NDA022233

Mar 1, 2016

POSFREA

NDA NDA203050

Aug 22, 2016

PALONOSETRON HYDROCHLORIDE

NDA NDA207963

Nov 21, 2017

PALONOSETRON HYDROCHLORIDE

NDA NDA208109

Sources

References

[1]
ClinicalTrials.gov — 1 trial record for palonosetron hydrochloride injection. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — palonosetron hydrochloride injection compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA208109). U.S. Food & Drug Administration.
[4]
SEC EDGAR — Avyxa company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Company: AAvyxa