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Treats pulmonary arterial hypertension (PAH, WHO Group I). Sold as Uptravi. Every FDA application for this active ingredient: 2 branded and 5 generic.
As of Nov 13, 2026, FDA lists 7 applications for Selexipag (sold as Uptravi), first approved Dec 21, 2015, with 2 new uses approved and 0 published complete response letters.
First approved: Dec 21, 2015
Applications: 7
New uses approved: 2
Complete response letters: 0
Medicare spending, 2025: $1.05B
First approved in Japan: Sep 28, 2016
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 9 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
Uptravi(1), (2) Drugs with a new additional pediatric dosage and other characteristics and (3) a drug with a new additional pediatric dosage in an additional… · Nippon Shinyaku Co., Ltd. · Dec 27, 2024
UptraviDrugs with a new indication for the treatment of persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) after surgical treatment or… · Nippon Shinyaku Co., Ltd. · Aug 25, 2021
Uptravi, new ingredientDrugs with a new active ingredient indicated for the treatment of pulmonary arterial hypertension. · Nippon Shinyaku Co., Ltd. · Sep 28, 2016 · Review report
Clinical Trials
11 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
Zydus Lifesciences
Alembic