UPTRAVI (selexipag)
UPTRAVI is indicated for the treatment of Pulmonary Arterial Hypertension.
How UPTRAVI Works
Selexipag is a selective prostacyclin receptor (IP receptor) agonist. It is hydrolyzed by carboxylesterase 1 to yield an active metabolite that is approximately 37-fold as potent as the parent compound. Both selexipag and its active metabolite are highly selective for the IP receptor over other prostanoid receptors (EP1–4, DP, FP, and TP).
Development Insights
Details
- Status
- Prescription
- First Approved
- 2015-12-21
- Patent Cliff
- 2037
- Revenue
- $500M (Q4-2025)
- Routes
- ORAL, INTRAVENOUS
- Dosage Forms
- TABLET, POWDER
UPTRAVI Approval History
What UPTRAVI Treats
1 indicationsUPTRAVI is approved for 1 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pulmonary Arterial Hypertension
UPTRAVI Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in UPTRAVI's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications UPTRAVI treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to UPTRAVI
3 of 18FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
16 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04175600 SALTO | CR108716 AC-065A310, 2019-002817-21 | Ph 3 | active not recruiting | A Study of Selexipag as Add-On Treatment to Standard of Care in Children With Pulmonary Arterial Hypertension |
| NCT05179876 PLATYPUS | CR109121 NOPRODPAPUH3001, 2021-002297-11 | Ph 3 | recruiting | A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option |
| NCT01106014 GRIPHON results posted | AC-065A302 | Ph 3 | completed | Selexipag (ACT-293987) in Pulmonary Arterial Hypertension |
| NCT03496506 | AC-065-117 | Ph 1 | completed | A Clinical Study to Assess the Effect of Clopidogrel on the Pharmacokinetics of Selexipag and Its Active Metabolite in Healthy Male Subjects |
| NCT04565990 SOMBRERO results posted | CR108892 2020-000475-21, 67896049PUH3001 | Ph 3 | completed | A Study of Selexipag in Participants Who Participated in a Previous Selexipag Study |
| NCT02558231 TRITON results posted | AC-065A308 | Ph 3 | completed | The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension |
| NCT03078907 TRACE results posted | AC-065A404 | Ph 4 | completed | Effect of Selexipag on Daily Life Physical Activity of Patients With Pulmonary Arterial Hypertension. |
| NCT02770222 | AC-065-113 2016-000811-34 | Ph 1 | completed | A Clinical Study to Investigate the Effect of Gemfibrozil or Rifampicin on Blood Concentrations of Selexipag in Healthy Subjects |
| NCT02260557 | AC-065C202 | Ph 2 | completed | Effects of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis |
| NCT02206295 | AC-065-108 | Ph 1 | completed | Study in Healthy Male Subjects to Demonstrate Bioequivalence of 1600 μg Selexipag Administered as Eight Tablets of 200 μg or as Single Tablet of 1600 μg |
| NCT05825417 PHoenix | STH21653 MR/W026279/1, 325120 | Ph 4 | recruiting | Pulmonary Hypertension: Intensification and Personalisation of Combination Rx |
| NCT03689244 SELECT results posted | AC-065B302 2018-002823-41 | Ph 3 | terminated | A Study to Find Out if Selexipag is Effective and Safe in Patients With Chronic Thromboembolic Pulmonary Hypertension When the Disease is Inoperable or Persistent/Recurrent After Surgery and/or Interventional Treatment |
| NCT03942211 SPHINX results posted | AC-065D301 2018-004887-74 | Ph 2 | terminated | A Study in Participants With Sarcoidosis-associated Pulmonary Hypertension (SAPH) to Assess the Efficacy and Safety of Oral Selexipag |
| NCT02471183 TRANSIT-1 results posted | AC-065A304 | Ph 3 | completed | Study to Assess the Tolerability and the Safety of the Transition From Inhaled Treprostinil to Oral Selexipag in Patients With Pulmonary Arterial Hypertension |
| NCT02791815 | AC-065-114 2016-000856-83 | Ph 1 | completed | Potential Pharmacokinetic Interaction Between Selexipag and Midazolam in Healthy Male Subjects |
| NCT02206204 | AC-065-106 | Ph 1 | completed | Study of Selexipag and Its Metabolite ACT-333679 on Cardiac Repolarization in Healthy Male and Female Subjects |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
UPTRAVI FDA Label Details
Indications & Usage
FDA Label (PDF)UPTRAVI is indicated for the treatment of Pulmonary Arterial Hypertension.
UPTRAVI Patents & Exclusivity
Patents (12 active)
Pro Intelligence Preview
Deep insights for UPTRAVI
Revenue Insights
- • Q4-2025: $500M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2037
- • 776 active patents
Trial Analysis
- • 16 total trials
- • Stage: Declining
Competitive Landscape
- • 18 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment