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Open-label Adalimumab
Open-label Adalimumab is a TNF-α inhibitor (monoclonal antibody) Biologic drug developed by AbbVie (prior sponsor, Abbott). It is currently in Phase 3 development for Rheumatoid arthritis, Crohn's disease, Ulcerative colitis. Also known as: ABT-D2E7, Humira, adalimumab.
Adalimumab is a monoclonal antibody that binds to and neutralizes tumor necrosis factor-alpha (TNF-α), reducing inflammatory signaling.
Adalimumab is an antibody that inhibits tumor necrosis factor, a protein involved in inflammation. It is used to treat conditions such as Sarcoidosis, Rheumatoid Arthritis, Crohn Disease, and Ankylosing Spondylitis.
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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
AbbVie (prior sponsor, Abbott) 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 | Open-label Adalimumab |
|---|---|
| Also known as | ABT-D2E7, Humira, adalimumab |
| Sponsor | AbbVie (prior sponsor, Abbott) |
| Drug class | TNF-α inhibitor (monoclonal antibody) |
| Target | TNF-α (tumor necrosis factor-alpha) |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Adalimumab blocks TNF-α, a key pro-inflammatory cytokine involved in immune-mediated diseases. By preventing TNF-α from binding to its receptors on immune cells and tissue, it suppresses the inflammatory cascade underlying autoimmune and inflammatory conditions. This mechanism has proven effective across multiple chronic inflammatory diseases.
Approved indications
- Rheumatoid arthritis
- Crohn's disease
- Ulcerative colitis
- Ankylosing spondylitis
- Psoriatic arthritis
- Psoriasis
- Hidradenitis suppurativa
- Juvenile idiopathic arthritis
Common side effects
- Injection site reactions
- Upper respiratory tract infections
- Headache
- Tuberculosis reactivation
- Serious infections
- Malignancy risk (increased)
Key clinical trials
- A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juvenile Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis (PHASE3)
- A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease (PHASE4)
- A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab (PHASE3)
- An Open-Label Study of Effectiveness of Immunomodulatory Medications for Patients With Relapsing Polychondritis (PHASE2)
- Study to Evaluate the Safety and Efficacy of Adalimumab in MPS I, II, and VI (PHASE1, PHASE2)
- Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis (PHASE3)
- Therapeutic Drug Monitoring-baSed adalimuMab De-escalatiOn in nOn-infecTious cHronic Uveitis (PHASE4)
- Study of the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of Netakimab in Children With Moderate to Severe Plaque Psoriasis (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:
- Open-label Adalimumab CI brief — competitive landscape report
- Open-label Adalimumab updates RSS · CI watch RSS
- AbbVie (prior sponsor, Abbott) portfolio CI
Frequently asked questions about Open-label Adalimumab
What is Open-label Adalimumab?
How does Open-label Adalimumab work?
What is Open-label Adalimumab used for?
Who makes Open-label Adalimumab?
Is Open-label Adalimumab also known as anything else?
What drug class is Open-label Adalimumab in?
What development phase is Open-label Adalimumab in?
What are the side effects of Open-label Adalimumab?
What does Open-label Adalimumab target?
Related
- Drug class: All TNF-α inhibitor (monoclonal antibody) drugs
- Target: All drugs targeting TNF-α (tumor necrosis factor-alpha)
- Manufacturer: AbbVie (prior sponsor, Abbott) — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Rheumatoid arthritis
- Indication: Drugs for Crohn's disease
- Indication: Drugs for Ulcerative colitis
- Also known as: ABT-D2E7, Humira, adalimumab
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing