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Selicrelumab (selicrelumab)
Selicrelumab (generic name: selicrelumab) is a Monoclonal antibody drug developed by Pfizer Inc.. It is currently in Phase 1 development.
Selicrelumab is an antibody that acts as an agonist to tumor necrosis factor receptor superfamily member 5. It is being studied in clinical trials for various conditions, including melanoma, pancreatic adenocarcinoma, and non-Hodgkin lymphoma.
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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
Pfizer Inc. 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 | selicrelumab |
|---|---|
| Sponsor | Pfizer Inc. |
| Modality | Monoclonal antibody |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
- Fatigue
- Nausea
- Anaemia
- Alopecia
- Diarrhoea
- Decreased appetite
- Constipation
- Oedema peripheral
- Pyrexia
- Neutropenia
- Vomiting
- Alanine aminotransferase increased
Key clinical trials
- A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer (PHASE1, PHASE2)
- A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer) (PHASE1, PHASE2)
- A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer (Morpheus-CRC) (PHASE1, PHASE2)
- Study of Intratumoral Selicrelumab With Atezolizumab in Patients With Refractory or Relapsed B Cell Lymphoma (PHASE1)
- Tremelimumab and CP-870,893 in Patients With Metastatic Melanoma (PHASE1)
- Study Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Therapeutic Activity of Selicrelumab (RO7009789) With Vanucizumab or Bevacizumab in Participants With Metastatic Solid Tumors (PHASE1)
- A Study of Selicrelumab (RO7009789) in Combination With Atezolizumab in Participants With Locally Advanced and/or Metastatic Solid Tumors (PHASE1)
- Phase 1, Open-Label, Dose-Escalation Study of CP-870,893 in Patients With Solid Tumors (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:
- Selicrelumab CI brief — competitive landscape report
- Selicrelumab updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI
Frequently asked questions about Selicrelumab
What is Selicrelumab?
Who makes Selicrelumab?
What is the generic name of Selicrelumab?
What development phase is Selicrelumab in?
What are the side effects of Selicrelumab?
Related
- Manufacturer: Pfizer Inc. — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing