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Tryvio (APROCITENTAN)
Tryvio works by blocking the action of endothelin, a protein that constricts blood vessels and increases blood pressure.
Tryvio (aprocitentan) is a small molecule endothelin receptor antagonist developed by Idorsia, targeting a range of cardiovascular and metabolic conditions. It has been FDA-approved since 2025 for indications including hypertension, stroke, and diabetes. Tryvio is a patented medication with no generic manufacturers available. Key safety considerations include its long half-life of 41 hours. As a relatively new medication, its long-term safety profile is still being evaluated.
At a glance
| Generic name | APROCITENTAN |
|---|---|
| Sponsor | Idorsia |
| Drug class | Endothelin Receptor Antagonist [EPC] |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2025 |
Mechanism of action
Aprocitentan is an ERA that inhibits the binding of endothelin (ET)-1 to ET A and ET B receptors. ET-1, via its receptors (ET A and ET B ), mediates a variety of deleterious effects such as vasoconstriction, fibrosis, cell proliferation, and inflammation. In hypertension, ET-1 can cause endothelial dysfunction, vascular hypertrophy and remodeling, sympathetic activation, and increased aldosterone synthesis.
Approved indications
- Hypertension
- Stroke
- Myocardial infarction
- Cardiovascular mortality
- Cardiovascular morbidity
- Diabetes
- Hyperlipidemia
- High blood pressure
- Cardiovascular risk
- Cardiovascular events
Boxed warnings
- 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 )
Common side effects
- Edema/fluid retention
- Anemia
- Hypersensitivity Reactions
- Decrease in estimated glomerular filtration rate
- Allergic dermatitis
- Rash
- Erythema
- Allergic edema
Key clinical trials
- A Drug-drug Interaction Trial in Healthy Female Participants to Investigate the Effect of Aprocitentan on Combined Hormonal Contraceptives (PHASE1)
- A Research Study to Show the Effect of Aprocitentan in the Treatment of Difficult to Control (Resistant) High Blood Pressure (Hypertension) and Find Out More About Its Safety (PHASE3)
- 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) (PHASE1)
- Clinical Study to Assess Body Fluid Homeostasis After Administration of ACT-132577 in Healthy Subjects (PHASE1)
- A Study to Evaluate ACT-132577 in Healthy Male Subjects (PHASE1)
- A Study to Investigate the Effect of ACT-132577 on the Pharmacokinetics of Midazolam and 1-hydroxy Midazolam in Healthy Male Subjects (PHASE1)
- Bioequivalence Study of Different Aprocitentan Tablet Formulations (PHASE1)
- To Study the Effect of Aprocitentan on the Electrical Activity of the Heart in Healthy Men and Women (PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Tryvio CI brief — competitive landscape report
- Tryvio updates RSS · CI watch RSS
- Idorsia portfolio CI