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palonosetron

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

palonosetron: sourced relationships with 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 company relationship 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

Dated Pipeline Records (2)
CompanyDated record stage
AKORN INC (AKRX)
Reported 2015-11-09 · Current development: unknownSource
Approved
DR REDDYS LABORATORIES LTD (RDY)
Reported 2016-04-21 · Current development: unknownSource
Approved
Clinical Trial Registry Records (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

NCT00343460Registry updated 2026-03-02·Phase 3
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
Approval(RDY)FDA ↗
ANDA201533Not ApplicableIntravenousInjectable
Tentative Approval(AKRX)FDA ↗
ANDA204731UNKNOWNOtherInjectable

Frequently asked questions

Which companies have sourced relationships with palonosetron?

palonosetron has dated SEC/FDA relationship records for 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, dated April 21, 2016.