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Macitentan/Tadalafil FDC
Macitentan/Tadalafil FDC 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: JNJ-68150420.
This fixed-dose combination blocks endothelin-1 receptors (via macitentan) to reduce pulmonary vascular resistance while simultaneously inhibiting phosphodiesterase-5 (via tadalafil) to promote vasodilation in the pulmonary circulation.
Macitentan/Tadalafil FDC is a fixed-dose combination of two drugs, macitentan and tadalafil, which are used to treat Pulmonary Arterial Hypertension (PAH). Macitentan works as an endothelin receptor antagonist, specifically targeting the ET-A/ET-B receptors, while tadalafil's mechanism is not specified in the provided facts.
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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 | Macitentan/Tadalafil FDC |
|---|---|
| Also known as | JNJ-68150420 |
| 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 hypertension. Tadalafil is a phosphodiesterase-5 inhibitor that increases cyclic GMP levels, promoting smooth muscle relaxation and vasodilation. Together, these complementary mechanisms address multiple pathways in pulmonary arterial hypertension pathophysiology.
Approved indications
- Pulmonary arterial hypertension (PAH)
Common side effects
- Headache
- Flushing
- Nasal congestion
- 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:
- Macitentan/Tadalafil FDC CI brief — competitive landscape report
- Macitentan/Tadalafil FDC updates RSS · CI watch RSS
- Actelion portfolio CI
Frequently asked questions about Macitentan/Tadalafil FDC
What is Macitentan/Tadalafil FDC?
How does Macitentan/Tadalafil FDC work?
What is Macitentan/Tadalafil FDC used for?
Who makes Macitentan/Tadalafil FDC?
Is Macitentan/Tadalafil FDC also known as anything else?
What drug class is Macitentan/Tadalafil FDC in?
What development phase is Macitentan/Tadalafil FDC in?
What are the side effects of Macitentan/Tadalafil FDC?
What does Macitentan/Tadalafil FDC 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: JNJ-68150420
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing