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Subcutaneous (SC) abatacept
Subcutaneous (SC) abatacept is a T-cell costimulation modulator Small molecule drug developed by Bristol-Myers Squibb. It is currently in Phase 3 development for Rheumatoid arthritis, Polyarticular juvenile idiopathic arthritis, Psoriatic arthritis. Also known as: BMS-188667, Orencia.
Abatacept is a fusion protein that blocks T-cell costimulation by binding to CD80/CD86 on antigen-presenting cells, thereby inhibiting T-cell activation and proliferation.
Subcutaneous abatacept is a protein modality that inhibits the T-lymphocyte activation antigen CD86, classified as an inhibitor. It is being studied for the treatment of conditions such as Type 1 Diabetes Mellitus, Polymyositis, Dermatomyositis, Autoimmune Necrotizing Myopathy, and Overlap Myositis.
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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). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable. -
Big-pharma sponsor
+3.0pp
Bristol-Myers Squibb 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 | Subcutaneous (SC) abatacept |
|---|---|
| Also known as | BMS-188667, Orencia |
| Sponsor | Bristol-Myers Squibb |
| Drug class | T-cell costimulation modulator |
| Target | CD80/CD86 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Abatacept (CTLA4-Ig) acts as a selective costimulation modulator that interrupts the second signal required for full T-cell activation. By binding to CD80 and CD86 molecules on dendritic cells and other antigen-presenting cells, it prevents interaction with CD28 on T cells, effectively suppressing the adaptive immune response. This mechanism makes it particularly useful in autoimmune conditions where T-cell-mediated inflammation drives disease pathology.
Approved indications
- Rheumatoid arthritis
- Polyarticular juvenile idiopathic arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Adult-onset Still's disease
Common side effects
- Infection (upper respiratory, urinary tract)
- Headache
- Nausea
- Dizziness
- Injection site reactions
Key clinical trials
- Study of COYA 302 for the Treatment of ALS (PHASE2)
- Rituximab-pvvr and Abatacept vs Rituximab-pvvr Alone in New Onset Type 1 Diabetes (PHASE2)
- A Study to Compare the Response to Treatment With Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive, and Shared Epitope-positive Rheumatoid Arthritis and an Inadequate Response to Methotrexate (PHASE3)
- Early Markers of Disease and Response to Therapy (EARLY_PHASE1)
- Trial to Evaluate the Efficacy and Safety of Abatacept in Combination With Standard Therapy Compared to Standard Therapy Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy (PHASE3)
- A Study to Investigate the Effectiveness of an Education Support Program on Medication Adherence in Italian Real Life Rheumatoid Arthritis (RA) Patients Treated With Subcutaneous (SC) Abatacept
- Safety and Efficacy of Abatacept in IgG4-Related Disease (PHASE2)
- Effects of Abatacept in Patients With Early Rheumatoid Arthritis (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:
- Subcutaneous (SC) abatacept CI brief — competitive landscape report
- Subcutaneous (SC) abatacept updates RSS · CI watch RSS
- Bristol-Myers Squibb portfolio CI
Frequently asked questions about Subcutaneous (SC) abatacept
What is Subcutaneous (SC) abatacept?
How does Subcutaneous (SC) abatacept work?
What is Subcutaneous (SC) abatacept used for?
Who makes Subcutaneous (SC) abatacept?
Is Subcutaneous (SC) abatacept also known as anything else?
What drug class is Subcutaneous (SC) abatacept in?
What development phase is Subcutaneous (SC) abatacept in?
What are the side effects of Subcutaneous (SC) abatacept?
What does Subcutaneous (SC) abatacept target?
Related
- Drug class: All T-cell costimulation modulator drugs
- Target: All drugs targeting CD80/CD86
- Manufacturer: Bristol-Myers Squibb — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Rheumatoid arthritis
- Indication: Drugs for Polyarticular juvenile idiopathic arthritis
- Indication: Drugs for Psoriatic arthritis
- Also known as: BMS-188667, Orencia
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing