ORENCIA (abatacept)
ORENCIA (abatacept) is a selective T cell costimulation modulator used to treat several chronic inflammatory autoimmune conditions and for transplant-related prophylaxis. It is indicated for adults with moderately to severely active rheumatoid arthritis, as well as patients aged two years and older with polyarticular juvenile idiopathic arthritis or active psoriatic arthritis. Additionally, the medication is used in combination with a calcineurin inhibitor and methotrexate to prevent acute graft versus host disease in patients undergoing hematopoietic stem cell transplantation from unrelated donors. Its use is not recommended in combination with other biologic disease-modifying antirheumatic drugs or Janus kinase inhibitors.
How ORENCIA Works
Abatacept functions by inhibiting the activation of T lymphocytes, which are implicated in the pathogenesis of inflammatory diseases like rheumatoid arthritis and psoriatic arthritis. The drug binds to CD80 and CD86, which blocks these molecules from interacting with CD28 on the surface of T cells. This blockade prevents the costimulatory signal necessary for the full activation and proliferation of T cells. By suppressing this immune response, the drug inhibits the production of inflammatory cytokines, including TNF alpha, interferon-γ, and interleukin-2.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2005-12-23
- Patent Cliff
- 2026
- Revenue
- $1.0B (Q4-2025)
- Routes
- IV (INFUSION)
- Dosage Forms
- INJECTABLE
ORENCIA Approval History
What ORENCIA Treats
4 indicationsORENCIA is approved for 4 conditions since its original approval in 2005. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Moderately to severely active rheumatoid arthritis in adults
- Moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older
- Active psoriatic arthritis in patients 2 years of age and older
- Prophylaxis of acute graft versus host disease in patients 2 years of age and older undergoing hematopoietic stem cell transplantation
ORENCIA Target & Pathway
ProTarget
A pro-inflammatory cytokine that plays a central role in immune responses and inflammation. Excess TNF contributes to autoimmune diseases like rheumatoid arthritis, psoriasis, and inflammatory bowel disease. Blocking TNF reduces inflammation and prevents tissue damage.
ORENCIA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ORENCIA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ORENCIA treats. First-in-class if their pivotal trials read out positive.
Clinical Trial Registry
89 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04380740 ABA3 | IRB-P00035528 20-227 | Ph 2 | recruiting | Extended vs Short-term Abatacept Dosing for Graft Versus Host Disease Prophylaxis |
| NCT07388563 | 10002363 002363-C | Ph 1 | suspended | Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma |
| NCT06145282 results posted | 10001635 001635-H | Ph 1, Ph 2 | active not recruiting | Non-myeloablative Haploidentical HCT Study for Patients With Sickle Cell Disease, Including Compromised Organ Function |
| NCT06008808 | 202401211 | Ph 1 | recruiting | Ruxolitinib With and Without CTLA-4 Ig Abatacept for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation |
| NCT06654882 SMART-JIA | Pro00115808 PLACER-2022C3-30331, EPM #8533 | Ph 3 | recruiting | Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis |
| NCT06929039 abatacept | KSHB002 | Ph 1 | completed | Open Label , Randomized, Three Arm Parallel Group Single Dose Comparative Pharmacokinetic , Safety and Immunogenicity Study in Healthy Subjects |
| NCT05917522 | DAIT RTB-015 | Ph 2 | recruiting | Assessment of Biomarker-Guided CNI Substitution In Kidney Transplantation |
| NCT02840175 AJIBIOREM | P 150902 2016-000312-15 | Ph 3 | completed | Treatment Tapering in JIA With Inactive Disease |
| NCT03924401 ASCENT | IRB00108549 | Ph 2 | active not recruiting | Acute GVHD Suppression Using Costimulation Blockade to Expand Non-malignant Transplant |
| NCT03929601 TN25 | Rituximab-pvvr and Abatacept UC4DK117009 | Ph 2 | active not recruiting | Rituximab-pvvr and Abatacept vs Rituximab-pvvr Alone in New Onset Type 1 Diabetes |
| NCT05621759 | 22-00674 | Ph 2 | active not recruiting | Cyclophosphamide, Abatacept, and Tacrolimus for the Prevention of GvHD |
| NCT07366801 | NCHPOI- 2025-14 | Ph 2, Ph 3 | recruiting | Co-infusion of Treg-enriched Donor Lymphocytes With CD3-depleted Hematopoietic Stem Cell Graft to Prevent Graft-versus Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation Among Children With Hematologic Malignancies |
| NCT04474847 | VCRC5528 | Ph 3 | recruiting | Abatacept for the Treatment of Giant Cell Arteritis |
| NCT01743131 results posted | IRB00058187 Abatacept Phase 2, Aba2, R01FD004099 | Ph 2 | completed | Abatacept as GVHD Prophylaxis Phase 2 |
| NCT04925375 ABCVILD | 2020-0876 R01FD007267 | Ph 2 | recruiting | Abatacept for the Treatment of Common Variable Immunodeficiency With Interstitial Lung Disease |
| NCT04955366 | STUDY00001855 | Ph 2 | active not recruiting | Abatacept Conversion in Kidney Transplantation |
| NCT03680092 results posted | 180383 | Ph 2 | completed | Comparing Cyclophosphamide and Abatacept With Standard of Care Treatment Following Stem Cell Transplantation |
| NCT07138898 | 25-00380 | Ph 2 | not yet recruiting | Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty |
| NCT06680661 | CASE1924 | Ph 2 | recruiting | ABBA CORD: dCBT w/ Abatacept for aGVHD Prophylaxis |
| NCT05080218 COVER | COVER-Main | Ph 4 | completed | COVID-19 VaccinE Response in Rheumatology Patients |
| NCT03457142 results posted | I 47217 NCI-2017-02430, I 47217 | Ph 2 | terminated | Abatacept, Ixazomib Citrate, and Dexamethasone in Treating Patients With Multiple Myeloma Resistant to Chemotherapy |
| NCT04909801 results posted | IM101-863 2020-000350-96, U1111-1247-1367 | Ph 3 | active not recruiting | 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 |
| NCT03215927 ATtackMy-ILD results posted | STUDY19030443 BMS: IM101-657 | Ph 2 | completed | Abatacept for the Treatment of Myositis-associated Interstitial Lung Disease |
| NCT05289167 | 21-00797 | Ph 1, Ph 2 | active not recruiting | Post-Transplant Cyclophosphamide, Bortezomib and Abatacept for the Prevention of Graft-versus-Host-Disease (GvHD) |
| NCT04872218 ATARI | CITO-2021-01 | Ph 2 | completed | Adjuvant Treatment With Abatacept to Promote Remission During Peanut Oral Immunotherapy |
| NCT03737708 | 506-MA-3187 | Ph 4 | completed | A Study Comparing Biologics + Methotrexate With Biologics + Tacrolimus in Patients With Rheumatoid Arthritis (RA) |
| NCT03882008 results posted | STUDY00004744 | Ph 4 | completed | A Study to Evaluate Biomarkers to Predict Efficacy of Abatacept in Rheumatoid Arthritis |
| NCT05981976 | IM101-920 | Ph 1 | completed | A Study to Evaluate the Drug Levels of Abatacept Converted From Drug Substance by Two Different Processes in Healthy Participants |
| NCT02108860 | ABROGATE 5527 2013-005535-24, U54AR057319 | Ph 3 | completed | Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's) |
| NCT03086343 results posted | M15-925 2016-000933-37 | Ph 3 | completed | 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 |
| NCT03652961 RAMBA results posted | s18-01164 | Ph 4 | completed | Rheumatoid Arthritis Memory B Cells and Abatacept |
| NCT02867800 | AAAQ2350 | Ph 1 | completed | Abatacept for GVHD Prophylaxis After Hematopoietic Stem Cell Transplantation for Pediatric Sickle Cell Disease |
| NCT01954979 | 13-358 | Ph 1 | completed | Abatacept to Treat Steroid Refractory Chronic Graft Versus Host Disease (cGVHD) |
| NCT04186871 results posted | IM014-029 2019-002205-22 | Ph 2 | completed | 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 |
| NCT05426252 | 1000075672 | Ph 1, Ph 2 | recruiting | Thal-Fabs: Reduced Toxicity Conditioning for High Risk Thalassemia |
| NCT03733067 | 190015 19-I-0015 | Ph 1, Ph 2 | withdrawn | Safety and Efficacy of Abatacept for Treating Chronic Cytopenia in Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Haploinsufficiency |
| NCT04593940 ACTIV-1 IM results posted | Pro00106301 | Ph 3 | completed | Immune Modulators for Treating COVID-19 |
| NCT01844518 results posted | IM101-301 2012-003195-39 | Ph 3 | completed | Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents With Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to Biologic or Non Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) |
| NCT03619876 AMiRA results posted | AAAS2235 | Ph 4 | terminated | Effects of Abatacept on Myocarditis in Rheumatoid Arthritis |
| NCT04472494 results posted | IM101-873 U1111-1250-4217 | Ph 2 | terminated | Study of Abatacept in the Treatment of Hospitalized COVID-19 Participants With Respiratory Compromise |
| NCT02594735 AID results posted | IRB 111418 | Ph 4 | completed | Abatacept in Juvenile Dermatomyositis |
| NCT03492658 | NL62584.058.17 | Ph 4 | completed | Abatacept to Silence Anti-citrullinated Protein Antibody-expressing B Cells in Rheumatoid Arthritis (ASCARA) |
| NCT01860976 ASTRAEA results posted | IM101-332 2012-002798-80 | Ph 3 | completed | Efficacy and Safety of Subcutaneous Abatacept in Adults With Active Psoriatic Arthritis |
| NCT02270957 ABC results posted | OMRF 13-38 | Ph 2 | completed | Clarification of Abatacept Effects in SLE With Integrated Biologic and Clinical Approaches |
| NCT03669861 results posted | IM101-744 | Ph 2 | completed | Safety and Efficacy of Abatacept in IgG4-Related Disease |
| NCT02504268 AVERT-2 results posted | IM101-550 2015-001275-50 | Ph 3 | completed | Effects of Abatacept in Patients With Early Rheumatoid Arthritis |
| NCT02592798 results posted | IM101-566 2015-005450-36 | Ph 2 | completed | Pilot Study to Evaluate the Safety and Efficacy of Abatacept in Adults and Children 6 Years and Older With Excessive Loss of Protein in the Urine Due to Either Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD) |
| NCT01835470 results posted | IM101-365 | Ph 3 | completed | Efficacy, Safety, Pharmacokinetics and Immunogenicity Study of Abatacept Administered Intravenously to Treat Active Polyarticular-course Juvenile Idiopathic Arthritis in Japan |
| NCT03714022 results posted | IM101-682 | Ph 1 | completed | A Study to Evaluate the Pharmacokinetics of Abatacept Converted From Drug Substance by Two Different Processes |
| NCT02353780 MAZERATI results posted | STUDY19040127 | Ph 4 | terminated | Mechanistic Studies of B- and T-Cell Function in RA Patients Treated With TNF Antagonists, Tocilizumab, or Abatacept |
Showing 50 of 89 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ORENCIA FDA Label Details
Indications & Usage
FDA Label (PDF)ORENCIA is indicated for the treatment of Moderately to severely active rheumatoid arthritis in adults; Moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older; Active psoriatic arthritis in patients 2 years of age and older; Prophylaxis of acute graft versus host disease in patients 2 years of age and older undergoing hematopoietic stem cell transplantation.
Pro Intelligence Preview
Deep insights for ORENCIA
Revenue Insights
- • Q4-2025: $1.0B
- • Historical trend analysis
Patent Timeline
- • Cliff: 2026
- • Generic/biosimilar risk
Trial Analysis
- • 91 total trials
- • Stage: Declining
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment