TheraRadar
Data updated: May 26, 2026

POSFREA (palonosetron hydrochloride)

Oncology Approved 2016-03-01
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
10
Years on Market

Details

Status
Discontinued
First Approved
2016-03-01
Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

AVYXA HOLDINGS
Active Ingredient: PALONOSETRON HYDROCHLORIDE

POSFREA Approval History

2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
6 FDA actions from 2016 to 2025 · 1 indication expansions
Apr 2025 SUPPL
Efficacy
FDA Letter Label
Jul 2024 SUPPL
Label · Labeling
FDA Letter Label
Mar 2016 ORIGINAL
Update · Type 5 - New Formulation or New Manufacturer
FDA Letter Label

What POSFREA Treats

2 FDA approvals

Originally approved for its first indication in 2016 . Covers 2 distinct patient populations.

  • Other (2)
📋

Clinical Trial Registry

8 trials
Trial Sponsor ID Phase Status Title
NCT03578081 results posted A221602 NCI-2017-02410, UG1CA189823 Ph 3 completed Olanzapine With or Without Fosaprepitant Dimeglumine in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Chemotherapy
NCT05315999 ProTreat P003161 Ph 2 completed Protreat-Trial: Prophylactic Antiemetic Treatment of Opioid-induced Nausea and Vomiting (OINV) in Palliative Care
NCT03040726 results posted 2016-0843 NCI-2017-00599, 2016-0843 Ph 2, Ph 3 completed Netupitant and Palonosetron Hydrochloride in Preventing Chronic Nausea and Vomiting in Patients With Cancer
NCT03097588 results posted STUDY00016288 NCI-2017-00548, STUDY00016288 Ph 2 completed Netupitant and Palonosetron Hydrochloride in Preventing Chemotherapy Induced Nausea and Vomiting in Patients With Cancer Undergoing BEAM Conditioning Regimen Before Stem Cell Transplant
NCT00553059 results posted 2006-0841 MDA-2006-0841, CDR0000573510 Ph 3 completed Palonosetron and Dexamethasone With or Without Dronabinol in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy For Cancer
NCT00903396 results posted NCCTG-N08C2 NCI-2009-01109, CDR0000642449 Ph 2 terminated Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer
NCT00895245 results posted 6862 NCI-2009-01669 Ph 2 terminated Fosaprepitant Dimeglumine, Palonosetron Hydrochloride, and Dexamethasone in Preventing Nausea and Vomiting Caused by Cisplatin in Patients With Stage III or Stage IV Head and Neck Cancer Undergoing Chemotherapy and Radiation Therapy
NCT01481831 ESPNV zhiruo Ph 4 completed Efficacy and Safety of Palonosetron Hydrochloride in the Prevention of Nausea and Vomiting
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

POSFREA FDA Label Details

Track POSFREA with TheraRadar Pro

Watchlist alerts, full database access, CSV exports across 14,000+ drugs.

Upgrade to Pro

Data Sources

FDA Approval: NDA203050 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.