Prescription medicine
Aprocitentan Brand names: Tryvio
Aprocitentan (Tryvio) is a prescription medicine with an FDA approval on record since 2024. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the aprocitentan FDA label on DailyMed (effective August 14, 2026, Idorsia Pharmaceuticals Ltd); the NDA 217686 record on Drugs@FDA; every aprocitentan label on DailyMed.
Highlights of the record
FDA label of August 14, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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
Used for
From the label: indications and usageTRYVIO, in combination with other antihypertensive drugs, is indicated for the treatment of hypertension, to lower blood pressure (BP) in adult patients who are not adequately controlled on other drugs.
Forms and strengths
- 12.5 mg
Film-coated tablet.
On the market
- Earliest approval on file
- March 19, 2024 Tryvio, Idorsia; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- July 26, 2038 Tryvio tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 19 through July 30, 2026
What is aprocitentan used for?
From the label: indications and usageTRYVIO, in combination with other antihypertensive drugs, is indicated for the treatment of hypertension, to lower blood pressure (BP) in adult patients who are not adequately controlled on other drugs. Lowering BP reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. There are no controlled trials demonstrating reduction of risk of these events with TRYVIO. […]
Conditions named in the indications of aprocitentan's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Endothelin Receptor Antagonist.
Source: FDA drug label (TRYVIO), Idorsia Pharmaceuticals Ltd, effective August 14, 2026 (SPL set dfe7a2ee-612c-4aba-834a-d68e6b59a0a6), via openFDA; the full label on DailyMed
What does the patient leaflet for aprocitentan say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about TRYVIO?TRYVIO may cause serious side effects, including: Serious birth defects. TRYVIO may cause serious birth defects if taken during pregnancy. Females who can become pregnant should not be pregnant when they start taking TRYVIO or become pregnant during treatment with TRYVIO or for 1 month after stopping treatment with TRYVIO. Females who can become pregnant should have a negative pregnancy test before starting treatment with TRYVIO. Females who can become pregnant are females who: have entered puberty, even if they have not started their menstrual period, and have a uterus, and have not gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed. Females who cannot become pregnant are females who: have not yet entered puberty, or do not have a uterus, or have gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed, or are infertile for other medical reasons and this infertility is permanent and cannot be reversed. Females who can become pregnant should use effective birth control before starting treatment with TRYVIO, during treatment with TRYVIO, and for 1 month after stopping TRYVIO because the medicine may still be in your body. Talk with your healthcare provider or gynecologist (a healthcare provider who specializes in female reproduction) to find out about options for effective birth control that you may use to prevent pregnancy during treatment with TRYVIO. If you decide that you want to change the form of birth control that you use, talk with your healthcare provider or gynecologist to be sure that you choose another acceptable form of birth control. […]
From the patient leaflet: How should I store TRYVIO?Store TRYVIO tablets at room temperature, between 68°F to 77°F (20°C and 25°C). Keep TRYVIO tablets in the original container. Tightly close the TRYVIO bottle cap each time after opening. The TRYVIO bottle contains a desiccant packet to help keep your tablets dry (protect them from moisture). Do not throw away the desiccant packet and keep it in the bottle. Protect TRYVIO from light and moisture. Keep TRYVIO and all medicines out of the reach of children.
Source: FDA drug label (TRYVIO), Idorsia Pharmaceuticals Ltd, effective August 14, 2026 (SPL set dfe7a2ee-612c-4aba-834a-d68e6b59a0a6), via openFDA; the full label on DailyMed
Is there a generic for aprocitentan (Tryvio)?
No generic aprocitentan is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 6 patents for Tryvio tablets: the compound patent runs to February 26, 2038, and the last listed entry to July 26, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2024 earliest approval on file
- 2038 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for aprocitentan?
The FDA Adverse Event Reporting System holds 19 reports that list aprocitentan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 4 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as aprocitentan?
72 other medicines are given the same way (oral) and in the same FDA class as aprocitentan or labeled mainly for the same use (high blood pressure), the same class first. High blood pressure lists all 88 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Metoprolol | High blood pressure | 64 labelers | $0.085 per tablet 100 mg tablet | A presentation being discontinued |
| Diltiazem | High blood pressure | 42 labelers | $0.144 per capsule 24h ER(cd) 120 mg capsule | A presentation being discontinued |
| Lisinopril | High blood pressure | 36 labelers | $0.0254 per tablet 20 mg tablet | No current entry |
| Propranolol | High blood pressure | 38 labelers | $0.0493 per tablet 20 mg tablet | In shortage |
| Losartan | High blood pressure | 44 labelers | $0.0327 per tablet 50 mg tablet | No current entry |
| Amlodipine | High blood pressure | 42 labelers | $0.0102 per tablet 5 mg tablet | No current entry |
| Clonidine | High blood pressure | 37 labelers | $0.0241 per tablet 0.1 mg tablet | No current entry |
| Valsartan | High blood pressure | 34 labelers | $0.0963 per tablet 40 mg tablet | A presentation being discontinued |
Every medicine labeled for the same conditions as aprocitentan
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to aprocitentan
- 72 medicines for the same use
- Other endothelin receptor antagonists
- the pharmacologic class, with prices and generics
- Aprocitentan side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other