Last reviewed · How we verify
adalimumab (D2E7)
adalimumab (D2E7) is a TNF inhibitor Biologic drug developed by Abbott. It is currently in Phase 3 development for Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis. Also known as: ABT-D2E7, adalimumab, Humira.
Adalimumab is a fully human monoclonal antibody that selectively binds to tumor necrosis factor-alpha (TNF-alpha), preventing its interaction with cell surface TNF receptors.
Adalimumab is a fully human monoclonal antibody that selectively binds to tumor necrosis factor-alpha (TNF-alpha), preventing its interaction with cell surface TNF receptors. Used for Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis.
-
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.
| 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 | adalimumab (D2E7) |
|---|---|
| Also known as | ABT-D2E7, adalimumab, Humira |
| Sponsor | Abbott |
| Drug class | TNF inhibitor |
| Target | TNF-alpha |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
By blocking TNF-alpha, adalimumab reduces inflammation and slows disease progression in various conditions. TNF-alpha is a cytokine that promotes inflammation and is involved in the pathogenesis of several autoimmune and inflammatory diseases. Adalimumab's mechanism of action is similar to other TNF inhibitors, such as infliximab and etanercept.
Approved indications
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Crohn's disease
- Ulcerative colitis
- Plaque psoriasis
Common side effects
- Injection site reaction
- Headache
- Fatigue
- Muscle pain
- Nausea
Key clinical trials
- BI 655066/ABBV-066 (Risankizumab) Compared to Active Comparator (Adalimumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis (PHASE3)
- A Study of the Efficacy and Safety of Adalimumab in Pediatric Subjects With Enthesitis Related Arthritis (PHASE3)
- A Study of the Long-term Safety and Efficacy of Adalimumab in Subjects With Intermediate-, Posterior-, or Pan-uveitis (PHASE3)
- Efficacy and Safety of Adalimumab in Subjects With Inactive Uveitis (PHASE3)
- Efficacy and Safety of Adalimumab in Patients With Active Uveitis (PHASE3)
- Long-term Open-label Safety and Efficacy Study of Adalimumab in Subjects With Ulcerative Colitis (PHASE3)
- Study of Adalimumab in Participants With Peripheral Spondyloarthritis (SpA) (PHASE3)
- Post-marketing Observational Study to Evaluate the Incremental Impact of AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary (VALUE)
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:
- adalimumab (D2E7) CI brief — competitive landscape report
- adalimumab (D2E7) updates RSS · CI watch RSS
- Abbott portfolio CI
Frequently asked questions about adalimumab (D2E7)
What is adalimumab (D2E7)?
How does adalimumab (D2E7) work?
What is adalimumab (D2E7) used for?
Who makes adalimumab (D2E7)?
Is adalimumab (D2E7) also known as anything else?
What drug class is adalimumab (D2E7) in?
What development phase is adalimumab (D2E7) in?
What are the side effects of adalimumab (D2E7)?
What does adalimumab (D2E7) target?
Related
- Drug class: All TNF inhibitor drugs
- Target: All drugs targeting TNF-alpha
- Manufacturer: Abbott — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Rheumatoid arthritis
- Indication: Drugs for Psoriatic arthritis
- Indication: Drugs for Ankylosing spondylitis
- Also known as: ABT-D2E7, adalimumab, Humira
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing