Last reviewed · How we verify
Abatacept subcutaneous
Abatacept subcutaneous is a T-cell co-stimulation 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.
Abatacept is a fusion protein that blocks T-cell co-stimulation by binding to CD80/CD86 on antigen-presenting cells, thereby inhibiting T-cell activation and reducing inflammatory responses.
Abatacept is a fusion protein that blocks T-cell co-stimulation by binding to CD80/CD86 on antigen-presenting cells, thereby inhibiting T-cell activation and reducing inflammatory responses. Used for Rheumatoid arthritis, Polyarticular juvenile idiopathic arthritis, Psoriatic arthritis.
-
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 | Abatacept subcutaneous |
|---|---|
| Sponsor | Bristol-Myers Squibb |
| Drug class | T-cell co-stimulation modulator |
| Target | CD80/CD86 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Abatacept (CTLA4-Ig) acts as a selective co-stimulation modulator that interrupts the interaction between antigen-presenting cells and T cells. By binding to CD80 and CD86 ligands, it prevents the second signal required for full T-cell activation, thereby suppressing the proliferation and differentiation of autoreactive T cells. This mechanism makes it particularly effective in autoimmune conditions where T-cell-mediated inflammation drives disease pathology.
Approved indications
- Rheumatoid arthritis
- Polyarticular juvenile idiopathic arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Systemic lupus erythematosus
Common side effects
- Infection (upper respiratory, urinary tract)
- Headache
- Nausea
- Dizziness
- Injection site reactions
Key clinical trials
- Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma (PHASE1)
- 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)
- Analysis of T and B Cell Repertoire Changes in Response to Orencia® (Abatacept) in Rheumatoid Arthritis
- Abatacept for the Treatment of Giant Cell Arteritis (PHASE3)
- Abatacept for the Treatment of Common Variable Immunodeficiency With Interstitial Lung Disease (PHASE2)
- Efficacy of a Sequential Treatment Strategy in Rheumatoid Arthritis (PHASE3)
- Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty (PHASE2)
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:
- Abatacept subcutaneous CI brief — competitive landscape report
- Abatacept subcutaneous updates RSS · CI watch RSS
- Bristol-Myers Squibb portfolio CI
Frequently asked questions about Abatacept subcutaneous
What is Abatacept subcutaneous?
How does Abatacept subcutaneous work?
What is Abatacept subcutaneous used for?
Who makes Abatacept subcutaneous?
What drug class is Abatacept subcutaneous in?
What development phase is Abatacept subcutaneous in?
What are the side effects of Abatacept subcutaneous?
What does Abatacept subcutaneous target?
Related
- Drug class: All T-cell co-stimulation 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
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing