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Adalimumab, new formulation
Adalimumab, new formulation is a TNF-alpha inhibitor Biologic drug developed by AbbVie (prior sponsor, Abbott). It is currently in Phase 2 development for Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis.
Adalimumab is a monoclonal antibody that binds to and inhibits tumor necrosis factor-alpha (TNF-alpha), a pro-inflammatory cytokine.
Adalimumab is a TNF-alpha inhibitor, classified as an antibody and a drug that inhibits tumor necrosis factor. It is used to treat rheumatoid arthritis, with a new formulation being compared to the current formulation in clinical trials for pharmacokinetic, pharmacodynamic, and safety assessments.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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 | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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, new formulation |
|---|---|
| Sponsor | AbbVie (prior sponsor, Abbott) |
| Drug class | TNF-alpha inhibitor |
| Target | TNF-alpha |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 2 |
Mechanism of action
By binding to TNF-alpha, adalimumab prevents it from interacting with its receptor on cell surfaces, thereby reducing inflammation and immune system activation. This mechanism is thought to contribute to its therapeutic effects in various autoimmune diseases.
Approved indications
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Crohn's disease
- Ulcerative colitis
Common side effects
- Injection site reactions
- Headache
- Fatigue
- Musculoskeletal pain
- Nausea
Key clinical trials
- Study in Rheumatoid Arthritis for Subjects Who Completed Preceding Study M13-390 With Adalimumab (PHASE2)
- A Study in Rheumatoid Arthritis (RA) Patients to Compare Two Formulations of Adalimumab for Pharmacokinetic, Pharmacodynamic and Safety (PHASE2)
- A Crossover Study of the Safety and Tolerability of Two Formulations of Adalimumab (PHASE2)
- Crossover Study of Safety and Tolerability of Two Formulations of Adalimumab. (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:
- Adalimumab, new formulation CI brief — competitive landscape report
- Adalimumab, new formulation updates RSS · CI watch RSS
- AbbVie (prior sponsor, Abbott) portfolio CI
Frequently asked questions about Adalimumab, new formulation
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Related
- Drug class: All TNF-alpha inhibitor drugs
- Target: All drugs targeting TNF-alpha
- Manufacturer: AbbVie (prior sponsor, Abbott) — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Rheumatoid arthritis
- Indication: Drugs for Psoriatic arthritis
- Indication: Drugs for Ankylosing spondylitis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing