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Double-blind Abatacept
Double-blind Abatacept is a CTLA-4 fusion protein (T-cell co-stimulation inhibitor) 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: Orencia, BMS-188667.
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.
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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 | Double-blind Abatacept |
|---|---|
| Also known as | Orencia, BMS-188667 |
| Sponsor | Bristol-Myers Squibb |
| Drug class | CTLA-4 fusion protein (T-cell co-stimulation inhibitor) |
| Target | CD80, CD86 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Abatacept works by interrupting the second signal required for full T-cell activation. It consists of the extracellular domain of CTLA-4 fused to the Fc portion of IgG1, allowing it to bind CD80 and CD86 molecules on antigen-presenting cells. This prevents the interaction between these molecules and CD28 on T cells, effectively dampening the adaptive immune response and reducing autoimmune inflammation.
Approved indications
- Rheumatoid arthritis
- Polyarticular juvenile idiopathic arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Systemic lupus erythematosus
Common side effects
- Infections (upper respiratory, urinary tract)
- Headache
- Nausea
- Dizziness
- Hypertension
Key clinical trials
- Study of COYA 302 for the Treatment of ALS (PHASE2)
- Extended vs Short-term Abatacept Dosing for Graft Versus Host Disease Prophylaxis (PHASE2)
- Abatacept for the Treatment of Giant Cell Arteritis (PHASE3)
- Abatacept for the Treatment of Common Variable Immunodeficiency With Interstitial Lung Disease (PHASE2)
- Abatacept in Immune Checkpoint Inhibitor Myocarditis (PHASE3)
- Adjuvant Treatment With Abatacept to Promote Remission During Peanut Oral Immunotherapy (PHASE2)
- A Phase 3 Study to Compare Upadacitinib to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease- Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs (PHASE3)
- Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis (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:
- Double-blind Abatacept CI brief — competitive landscape report
- Double-blind Abatacept updates RSS · CI watch RSS
- Bristol-Myers Squibb portfolio CI
Frequently asked questions about Double-blind Abatacept
What is Double-blind Abatacept?
How does Double-blind Abatacept work?
What is Double-blind Abatacept used for?
Who makes Double-blind Abatacept?
Is Double-blind Abatacept also known as anything else?
What drug class is Double-blind Abatacept in?
What development phase is Double-blind Abatacept in?
What are the side effects of Double-blind Abatacept?
What does Double-blind Abatacept target?
Related
- Drug class: All CTLA-4 fusion protein (T-cell co-stimulation inhibitor) 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: Orencia, BMS-188667
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing