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Evobrutinib MUPS-C1
Evobrutinib MUPS-C1 is a Bruton's tyrosine kinase (BTK) inhibitor Small molecule drug developed by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany. It is currently in Phase 1 development. Also known as: M2951.
Evobrutinib inhibits Bruton's tyrosine kinase (BTK), blocking B-cell activation and inflammatory signaling pathways.
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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
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany 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 | Evobrutinib MUPS-C1 |
|---|---|
| Also known as | M2951 |
| Sponsor | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany |
| Drug class | Bruton's tyrosine kinase (BTK) inhibitor |
| Modality | Small molecule |
| Phase | Phase 1 |
Mechanism of action
BTK is a key enzyme in B-cell receptor signaling that regulates B-cell development, activation, and survival. By inhibiting BTK, evobrutinib reduces pathogenic B-cell activity and inflammatory responses implicated in autoimmune diseases.
Approved indications
Common side effects
Key clinical trials
- Study Comparing Pharmacokinetics of Different Formulations of Evobrutinib in Healthy 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:
- Evobrutinib MUPS-C1 CI brief — competitive landscape report
- Evobrutinib MUPS-C1 updates RSS · CI watch RSS
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany portfolio CI
Frequently asked questions about Evobrutinib MUPS-C1
What is Evobrutinib MUPS-C1?
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Related
- Drug class: All Bruton's tyrosine kinase (BTK) inhibitor drugs
- Manufacturer: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany — full pipeline
- Also known as: M2951
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing