TRYVIO (aprocitentan)
Tryvio helps adults with high blood pressure that is not sufficiently managed by other medications. It is used in combination with other blood pressure drugs to help lower a patient's overall blood pressure. By achieving better control of these levels, the medication helps reduce the risk of serious cardiovascular events, such as heart attacks and strokes.
How TRYVIO Works
This medication works by blocking endothelin-1 from binding to its receptors, known as ET_A and ET_B. Endothelin-1 is a molecule that causes blood vessels to constrict and promotes issues like inflammation and vascular thickening. By inhibiting these receptors, the drug helps counteract these effects to improve blood flow and lower pressure.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2024-03-19
- Patent Cliff
- 2038
- Routes
- ORAL
- Dosage Forms
- TABLET
TRYVIO Approval History
What TRYVIO Treats
1 indicationsTRYVIO is approved for 1 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
TRYVIO Boxed Warning
EMBRYO-FETAL TOXICITY TRYVIO is contraindicated for use during pregnancy because it may cause fetal harm if used by pregnant patients. Therefore in patients who can become pregnant, exclude pregnancy prior to initiation of TRYVIO. Advise use of effective contraception before the start of TRYVIO, during treatment and for one month after stopping treatment. When pregnancy is detected, discontinue TRYVIO as soon as possible [see Dosage and Administration (2.2) , Contraindications (4.1) , Warnings a...
WARNING: EMBRYO-FETAL TOXICITY TRYVIO is contraindicated for use during pregnancy because it may cause fetal harm if used by pregnant patients. Therefore in patients who can become pregnant, exclude pregnancy prior to initiation of TRYVIO. Advise use of effective contraception before the start of TRYVIO, during treatment and for one month after stopping treatment. When pregnancy is detected, discontinue TRYVIO as soon as possible [see Dosage and Administration (2.2) , Contraindications (4.1) , Warnings and Precautions (5.1) , Use in Specific Populations (8.1) ] . WARNING: EMBRYO–FETAL TOXICITY See full prescribing information for complete boxed warning. Based on animal data TRYVIO may cause fetal harm if used by pregnant patients and is contraindicated in pregnancy. ( 4.1 , 5.1 , 8.1 ) For patients who can become pregnant, exclude pregnancy prior to initiation of treatment with TRYVIO. ( 2.2 , 5.1 , 8.3 ) Use effective contraception prior to initiation of treatment, during treatment, and for one month after stopping TRYVIO. ( 2.2 , 4.1 , 5.1 , 8.3 ) When pregnancy is detected, discontinue TRYVIO as soon as possible ( 5.1 )
TRYVIO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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 TRYVIO's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TRYVIO treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to TRYVIO
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06799884 | ID-080-111 2024-517224-19-00 | Ph 1 | completed | A Drug-drug Interaction Trial in Healthy Female Participants to Investigate the Effect of Aprocitentan on Combined Hormonal Contraceptives |
| NCT02841761 | AC-080-103 | Ph 1 | completed | A Study to Investigate the Effect of ACT-132577 on the Pharmacokinetics of Midazolam and 1-hydroxy Midazolam in Healthy Male Subjects |
| NCT02708004 | AC-080-102 | Ph 1 | completed | Clinical Study to Assess Body Fluid Homeostasis After Administration of ACT-132577 in Healthy Subjects |
| NCT03245229 | AC-080-106 | Ph 1 | completed | A Study in Healthy Male Subjects to Investigate Whether Administration of ACT-132577 Can Affect Rosuvastatin's Fate in the Body (Amount and Time of Presence in the Blood) |
| NCT04252495 | ID-080-109 2019-003580-21 | Ph 1 | completed | The Effect of Hepatic Impairment on Aprocitentan Pharmacokinetics |
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.
TRYVIO FDA Label Details
Indications & Usage
FDA Label (PDF)TRYVIO is indicated for the treatment of Hypertension.
WARNING: EMBRYO-FETAL TOXICITY TRYVIO is contraindicated for use during pregnancy because it may cause fetal harm if used by pregnant patients. Therefore in patients who can become pregnant, exclude pregnancy prior to initiation of TRYVIO. Advise use of effective contraception before the start of TR...
TRYVIO Patents & Exclusivity
Patents (6 active)
Exclusivity
Pro Intelligence Preview
Deep insights for TRYVIO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2038
- • 6 active patents
Trial Analysis
- • 5 total trials
- • Stage: Declining
Competitive Landscape
- • 20 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