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Dalantercept plus sorafenib
Dalantercept plus sorafenib is a Anti-angiogenic combination therapy Small molecule drug developed by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA. It is currently in Phase 1 development. Also known as: ACE-041.
Dalantercept inhibits ALK-1 signaling to disrupt tumor angiogenesis, while sorafenib blocks multiple kinases involved in tumor growth and blood vessel formation.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Dalantercept plus sorafenib |
|---|---|
| Also known as | ACE-041 |
| Sponsor | Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA |
| Drug class | Anti-angiogenic combination therapy |
| Modality | Small molecule |
| Phase | Phase 1 |
Mechanism of action
Dalantercept is a soluble receptor fusion protein that binds BMP9 and BMP10, blocking ALK-1 signaling to inhibit angiogenesis. Sorafenib inhibits VEGFR, PDGFR, and RAF kinases. The combination aims to provide dual anti-angiogenic and anti-tumor effects through complementary mechanisms.
Approved indications
Common side effects
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Dalantercept plus sorafenib CI brief — competitive landscape report
- Dalantercept plus sorafenib updates RSS · CI watch RSS
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA portfolio CI
Frequently asked questions about Dalantercept plus sorafenib
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Related
- Drug class: All Anti-angiogenic combination therapy drugs
- Manufacturer: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA — full pipeline
- Also known as: ACE-041
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing