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FDC macitentan/tadalafil
FDC macitentan/tadalafil is a Endothelin receptor antagonist / Phosphodiesterase-5 inhibitor combination Small molecule drug developed by Actelion. It is currently in Phase 3 development for Pulmonary arterial hypertension (PAH). Also known as: ACT-064992D.
This fixed-dose combination blocks endothelin-1 receptors (via macitentan) and phosphodiesterase-5 (via tadalafil) to reduce pulmonary vascular resistance and improve exercise capacity in pulmonary arterial hypertension.
This fixed-dose combination blocks endothelin-1 receptors (via macitentan) and phosphodiesterase-5 (via tadalafil) to reduce pulmonary vascular resistance and improve exercise capacity in pulmonary arterial hypertension. Used for Pulmonary arterial hypertension (PAH).
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | FDC macitentan/tadalafil |
|---|---|
| Also known as | ACT-064992D |
| Sponsor | Actelion |
| Drug class | Endothelin receptor antagonist / Phosphodiesterase-5 inhibitor combination |
| Target | Endothelin receptor A and B / Phosphodiesterase-5 |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Macitentan is an endothelin receptor antagonist that blocks the vasoconstrictive and proliferative effects of endothelin-1 in pulmonary vessels. Tadalafil is a phosphodiesterase-5 inhibitor that increases cyclic GMP, promoting vasodilation and reducing right ventricular afterload. The combination targets complementary pathways in pulmonary hypertension pathophysiology.
Approved indications
- Pulmonary arterial hypertension (PAH)
Common side effects
- Headache
- Nasal congestion
- Flushing
- Peripheral edema
- Anemia
Key clinical trials
- A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option (PHASE3)
- Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH) (PHASE3)
- A Study to Compare the Macitentan-tadalafil Fixed Dose Combination Tablet Relative to the Concomitant Administration of the Reference Tablets of Macitentan and Tadalafil in Healthy Subjects (PHASE1)
- A Study of Macitentan and Tadalafil as a Fixed Dose Combination and the Free Combination in Healthy Adult Participants (PHASE1)
- A Study of Macitentan/Tadalafil Combination Administered a Fixed-dose Combination Formulation Compared to the Reference Free Combination of Macitentan and Tadalafil (PHASE1)
- A Study of Fixed Dose Combination of Macitentan/Tadalafil (10 mg/20 mg) Compared to the Reference Free Combination of Macitentan and Tadalafil in Healthy Adult Participants (PHASE1)
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- FDC macitentan/tadalafil CI brief — competitive landscape report
- FDC macitentan/tadalafil updates RSS · CI watch RSS
- Actelion portfolio CI
Frequently asked questions about FDC macitentan/tadalafil
What is FDC macitentan/tadalafil?
How does FDC macitentan/tadalafil work?
What is FDC macitentan/tadalafil used for?
Who makes FDC macitentan/tadalafil?
Is FDC macitentan/tadalafil also known as anything else?
What drug class is FDC macitentan/tadalafil in?
What development phase is FDC macitentan/tadalafil in?
What are the side effects of FDC macitentan/tadalafil?
What does FDC macitentan/tadalafil target?
Related
- Drug class: All Endothelin receptor antagonist / Phosphodiesterase-5 inhibitor combination drugs
- Target: All drugs targeting Endothelin receptor A and B / Phosphodiesterase-5
- Manufacturer: Actelion — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Pulmonary arterial hypertension (PAH)
- Also known as: ACT-064992D
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing