TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

AMBRISENTAN

AMBRISENTAN Endothelin Receptor Antagonists
Approved 2019-03-28
Jump to: Indications Approvals Trials Competitors Safety Patents
5
Indications
--
Phase 3 Trials
6
Years on Market

Details

Status
Prescription
First Approved
2019-03-28
Routes
ORAL
Dosage Forms
TABLET

Companies

Aurobindo Pharma WATSON LABS INC Apotex Viatris SIGMAPHARM LABS LLC PH HEALTH Sun Pharma ZYDUS PHARMS Cipla
Active Ingredient: AMBRISENTAN

AMBRISENTAN Approval History

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What AMBRISENTAN Treats

5 FDA approvals

Originally approved for its first indication in 2019 . Covers 5 distinct patient populations.

  • Other (5)
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

AMBRISENTAN FDA Label Details

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Data Sources

FDA Approval: ANDA216531 → Label: DailyMed → Trials: ClinicalTrials.gov →

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