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Uptravi FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 6, 2021.

FDA Approved: Yes (First approved December 21, 2015)
Brand name: Uptravi
Generic name: selexipag
Dosage form: Tablets and Lyophilized Powder for Injection
Company: Actelion Pharmaceuticals US, Inc.
Treatment for: Pulmonary Arterial Hypertension

Uptravi (selexipag) is a prostacyclin receptor agonist for the treatment of pulmonary arterial hypertension (PAH).

  • Uptravi is indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH.
  • Uptravi is administered orally (Uptravi tablets) or by intravenous infusion (Uptravi IV) twice daily.
  • Uptravi IV is used in patients who are temporarily unable to take oral therapy. 
  • Common adverse reactions include headache, diarrhea, jaw pain, nausea, myalgia, vomiting, pain in extremity, and flushing.

Development Timeline for Uptravi

DateArticle
Jul 30, 2021Approval  Uptravi (selexipag) Receives FDA Approval for Intravenous Use in Adult Patients with Pulmonary Arterial Hypertension (PAH)
Dec 22, 2015Approval  FDA Approves Uptravi (selexipag) for Pulmonary Arterial Hypertension
Mar  3, 2015Actelion's NDA for Selexipag (Uptravi) Accepted by the FDA
Dec 23, 2014Actelion Submits NDA for Selexipag (Uptravi) in Patients with Pulmonary Arterial Hypertension

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.