AMBRISENTAN

Post-LOE

ambrisentan

Viatris (2)

ANDAORALTABLET

Approved

Mar 2019

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

5/8 — Partial

AMBRISENTAN (ambrisentan) by Viatris (2) is endothelin receptor antagonists [moa]. Approved for pulmonary arterial hypertension (pah) (who group 1) in adult patients: • to improve exercise ability, delay clinical worsening, hypertension. First approved in 2019.

Drug data last refreshed 18h ago

$0.0BPart D

Mechanism of Action

Endothelin Receptor Antagonists

Pharmacologic Class:

Endothelin Receptor Antagonist

Indications (3)

pulmonary arterial hypertension (PAH) (WHO Group 1) in adult patients: • To improve exercise ability delay clinical worsening

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.

Clinical Trials (20)

NCT04095286Phase 1Completed

Relative Bioavailability Study of Marketed and Lower Dose Ambrisentan in Healthy Adult Participants

Started Sep 2019

29 enrolled

Hypertension, Pulmonary

NCT03309592Phase 4Withdrawn

Efficacy and Safety of Combination Ambrisentan and Tadalafil in Patients With Portopulmonary Hypertension

Started Oct 2017

Portopulmonary HypertensionPulmonary HypertensionCirrhosis, Liver

NCT02999906Phase 3Withdrawn

Study to Compare Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial Hypertension

Started Oct 2017

Pulmonary Arterial Hypertension

NCT02688387Phase 1Completed

A Phase 1 Relative Bioavailability Study of Ambrisentan and Tadalfil Fixed Dose Combination Tablets in Healthy Subjects

Started Mar 2016

112 enrolled

Hypertension, Pulmonary

NCT02253394Phase 4Terminated

The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study

Started Sep 2015

2 enrolled

Pulmonary Arterial Hypertension