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Anti-TNF agents
Anti-TNF agents is a TNF-alpha inhibitor Small molecule drug developed by Altuğ Güner. It is currently in Phase 2 development for Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis. Also known as: Anti-TNF agents users for the last 5 years..
Anti-TNF agents work by binding to and inhibiting tumor necrosis factor-alpha (TNF-alpha), a pro-inflammatory cytokine involved in systemic inflammation.
Anti-TNF agents are used to treat conditions such as Juvenile Idiopathic Arthritis Associated Uveitis, Rheumatoid Arthritis, and Coccidioidomycosis, as indicated by ClinicalTrials.gov. The exact mechanism of action of Anti-TNF agents is unknown, according to ChEMBL.
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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.
| 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 | Anti-TNF agents |
|---|---|
| Also known as | Anti-TNF agents users for the last 5 years. |
| Sponsor | Altuğ Güner |
| Drug class | TNF-alpha inhibitor |
| Target | TNF-alpha |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 2 |
Mechanism of action
TNF-alpha plays a key role in the regulation of immune cells and the promotion of inflammation. By inhibiting TNF-alpha, anti-TNF agents reduce inflammation and modulate the immune response, which can help alleviate symptoms of various autoimmune diseases.
Approved indications
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Crohn's disease
- Ulcerative colitis
Common side effects
- Injection site reaction
- Headache
- Fatigue
- Nausea
- Diarrhea
Key clinical trials
- Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis (PHASE3)
- Association of Erectile Dysfunction With Neuropathic Pain, Disease Activity, and Functional Status in Male Patients With Axial Spondyloarthritis: A Cross-Sectional Observational Study
- Lumbar Spinal Fibrosis and TNF Alpha Inhibition (PHASE3)
- Stand UP to Rheumatoid Arthritis (SUPRA) (NA)
- Multicenter Randomized Double Blind Controlled-study to Assess the Potential of Methotrexate Versus Placebo to Improve and Maintain Response to Anti TNF- Alpha Agents in Adult Patients With Moderate to Severe Psoriasis (PHASE4)
- Efficacy of a Sequential Treatment Strategy in Rheumatoid Arthritis (PHASE3)
- A Study of Pharmacokinetics, Safety, and Immunogenicity of BCD-057 100 mg/mL, BCD-057 50 mg/mL, and Humira 100 mg/mL in Healthy Subjects (PHASE1)
- Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases (NA)
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:
- Anti-TNF agents CI brief — competitive landscape report
- Anti-TNF agents updates RSS · CI watch RSS
- Altuğ Güner portfolio CI
Frequently asked questions about Anti-TNF agents
What is Anti-TNF agents?
How does Anti-TNF agents work?
What is Anti-TNF agents used for?
Who makes Anti-TNF agents?
Is Anti-TNF agents also known as anything else?
What drug class is Anti-TNF agents in?
What development phase is Anti-TNF agents in?
What are the side effects of Anti-TNF agents?
What does Anti-TNF agents target?
Related
- Drug class: All TNF-alpha inhibitor drugs
- Target: All drugs targeting TNF-alpha
- Manufacturer: Altuğ Güner — 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: Anti-TNF agents users for the last 5 years.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing