Asset profile
Sotatercept · Winrevair
Protein / enzyme therapeutic
Evidence outlook · results not reported
ZENITH (NCT04896008) · Pulmonary Arterial Hypertension
The lead study's design has limits that temper confidence (see the rationale below), and its results have not been reported. This tier describes the design, not an outcome.
ZENITH (NCT04896008): This trial used real randomization, triple-blinding, a placebo control, and a hard composite clinical endpoint (death, transplant, or hospitalization) in a reasonably sized population (172 participants), a strong design overall. However, the posted results show only descriptive time-to-event estimates (median not reached vs. 9.6 months) without a formal statistical comparison (no hazard ratio or p-value) provided in the record, so whether the primary endpoint was formally met cannot be confirmed from this data alone.
Also in development:Heart Failure · Phase 3
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Featured trials
The studies most instrumental to this drug's clinical progression, individually graded on design and result. Pick an indication; Research unlocks the trials, endpoints, key results and grades.
Competitive landscape
116 competitors in this universe: 1 direct rival (same mechanism and indication), 1 same-class, 114 same-indication; 23 further along in development.
| Drug | Stage | Modality | Mechanism | Evidence signal | Reported efficacygraded featured trials |
|---|---|---|---|---|---|
| Sotatercept (Winrevair): this drug | Phase 3 | Protein / enzyme therapeutic | Activin receptor type IIA (ActRIIA) | ||
| HS235 | Phase 1/2 | Peptide | Activin receptor type IIA (ActRIIA) | ||
| ImmuneOnco Anti-PAH Candidate (IMC-003) | Phase 1/2 | Biologic (subtype unspecified) | Activin receptor type IIA (ActRIIA) | ||
| Aprocitentan (Tryvio) | Approved | Small molecule | Endothelin receptor (ETA/ETB, dual) | ||
| Baxdrostat (Baxfendy) | Approved | Small molecule | Aldosterone synthase (CYP11B2) | ||
| Bosentan (Tracleer) | Approved | Small molecule | Endothelin receptor (ETA/ETB, dual) | ||
| Dapagliflozin (Farxiga / Forxiga) | Approved | Small molecule | SGLT2 | ||
| Empagliflozin (Jardiance) | Approved | Small molecule | SGLT2 | ||
| Epoprostenol (Flolan) | Approved | Small molecule | IP receptor (prostacyclin pathway) | ||
| Ferric Carboxymaltose (Injectafer / Ferinject) | Approved | Iron Complex (iv) | Iron repletion | ||
| Ferric Derisomaltose (Monoferric / Monofer) | Approved | Iron Complex (iv) | Iron repletion | ||
| Finerenone (Kerendia) | Approved | Small molecule | Mineralocorticoid receptor | ||
| Furosemide (subcutaneous, scPharmaceuticals) (FUROSCIX) | Approved | Small molecule | NKCC2 | ||
| Furosemide (subcutaneous, SQ Innovation) (Lasix ONYU) | Approved | Small molecule | NKCC2 | ||
| Icodextrin (peritoneal Ultrafiltration) (Extraneal) | Approved | Device Solution (peritoneal Dialysis) | Peritoneal ultrafiltration | ||
| Isosorbide Dinitrate / Hydralazine (BiDil) | Approved | Small molecule | Hydralazine/isosorbide dinitrate (fixed combination) |
…and 101 more. Research shows the complete landscape.
Unlock the full comparison
Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.
Compare head-to-head
Upcoming events
(16 total)
Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.
2026 (1)
December 2026 (1)
What to watch
2027 (1)
August 2027 (1)
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2028 (9)
January 2028 (2)
March 2028 (2)
April 2028 (1)
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June 2028 (1)
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September 2028 (1)
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October 2028 (1)
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December 2028 (1)
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2029 (3)
January 2029 (1)
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February 2029 (1)
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May 2029 (1)
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2030 (1)
January 2030 (1)
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2035 (1)
August 2035 (1)
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All registered studies
Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.