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SAR153191 (REGN88)
SAR153191 (REGN88) is a PD-1 inhibitor Small molecule drug developed by Sanofi. It is currently in Phase 3 development for Non-small cell lung cancer, Head and neck squamous cell carcinoma.
SAR153191 is a monoclonal antibody that targets the PD-1 receptor.
SAR153191 (REGN88) is an interleukin-6 receptor alpha subunit antagonist, classified as an antibody antagonist. It is being studied in clinical trials for various conditions, including Ankylosing Spondylitis, COVID-19, and Recurrent Ovarian Cancer.
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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). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway. -
Big-pharma sponsor
+3.0pp
Sanofi 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 | 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 | SAR153191 (REGN88) |
|---|---|
| Sponsor | Sanofi |
| Drug class | PD-1 inhibitor |
| Target | PD-1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
By binding to PD-1, SAR153191 prevents the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby releasing the brakes on T-cell activation and proliferation, leading to enhanced anti-tumor immune responses.
Approved indications
- Non-small cell lung cancer
- Head and neck squamous cell carcinoma
Common side effects
- Pneumonitis
- Hypothyroidism
- Hyperthyroidism
Key clinical trials
- A Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Systemic Juvenile Idiopathic Arthritis (SKYPS) (PHASE2)
- A Trial to Find Out if REGN4336 is Safe and How Well it Works Alone and in Combination With Cemiplimab or REGN5678 for Adult Participants With Advanced Prostate Cancer (PHASE1, PHASE2)
- Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer (PHASE2)
- Study of REGN4018 (Ubamatamab) Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers (PHASE1, PHASE2)
- Sarilumab COVID-19 (PHASE3)
- An Observational Study on Sarilumab-exposed Pregnancies
- An Open-label, Ascending, Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) (PHASE2)
- Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica (PHASE3)
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:
- SAR153191 (REGN88) CI brief — competitive landscape report
- SAR153191 (REGN88) updates RSS · CI watch RSS
- Sanofi portfolio CI
Frequently asked questions about SAR153191 (REGN88)
What is SAR153191 (REGN88)?
How does SAR153191 (REGN88) work?
What is SAR153191 (REGN88) used for?
Who makes SAR153191 (REGN88)?
What drug class is SAR153191 (REGN88) in?
What development phase is SAR153191 (REGN88) in?
What are the side effects of SAR153191 (REGN88)?
What does SAR153191 (REGN88) target?
Related
- Drug class: All PD-1 inhibitor drugs
- Target: All drugs targeting PD-1
- Manufacturer: Sanofi — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Non-small cell lung cancer
- Indication: Drugs for Head and neck squamous cell carcinoma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing