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palonosetron

Generic: PALONOSETRON HYDROCHLORIDE·Brand: ALOXI, Akynzeo, PALONOSETRON HYDROCHLORIDE, POSFREA, Posfrea

palonosetron: developed by 2 companies · 1 clinical trial tracked · 2 FDA decisions.

palonosetron evidence translation

What we can confirm

2 FDA records · 1 tracked trial

What it means

More than one developer is source-backed. Until you choose one, AI stays drug-only and does not guess ownership.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

What is verified about palonosetron, and what remains unknown?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence0 indications · 1 study sponsors

Related indications

No linked indication is available.

Development Pipeline (2)
CompanyPhase
AKORN INC (AKRX)Approved
DR REDDYS LABORATORIES LTD (RDY)Approved
Clinical Trials (1)

A Pivotal Phase 3 Observer-Blind, Randomized Clinical Trial of the Efficacy and Safety of APF530 Compared to Aloxi For The Prevention of Acute-Onset and Delayed-Onset Chemotherapy-Induced Nausea and Vomiting Following The Administration of Either Moderately or Highly Emetogenic Chemotherapy Regimens

NCT00343460·Phase 3·HRTX
Completed

Primary endpoint: Proportion of Patients With Complete Response (CR) During Acute Phase (0-24 Hours) After Administration of Chemotherapy Course 1

InterventionalRandomizeddouble1,428 enrolledStarted 2006-06Completion 2009-0250 sites · United StatesHeron Therapeutics
FDA Decisions2 records
Approval1 INDICATIONS AND USAGE Palonosetron hydrochloride injection is a serotonin-3 (5-HT 3 ) receptor antagonist indicated in: Adults for prevention of : acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). ( 1 ) acute nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC). ( 1 ) postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy b(RDY)FDA ↗
ANDA201533Not ApplicableIntravenousInjectable
Tentative Approval(AKRX)FDA ↗
ANDA204731UNKNOWNOtherInjectable

Frequently asked questions

Who is developing palonosetron?

palonosetron is being developed by AKORN INC, DR REDDYS LABORATORIES LTD.

How many clinical trials involve palonosetron?

BioSniper tracks 1 clinical trial involving palonosetron.

What is palonosetron's latest FDA decision?

The most recent tracked FDA decision for palonosetron is Approval for 1 INDICATIONS AND USAGE Palonosetron hydrochloride injection is a serotonin-3 (5-HT 3 ) receptor antagonist indicated in: Adults for prevention of : acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). ( 1 ) acute nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC). ( 1 ) postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy b, dated April 21, 2016.