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Tyk2 inhibitor
Tyk2 inhibitor is a Small molecule drug developed by Usynova Pharmaceuticals Ltd.. It is currently in Phase 1 development.
Delgocitinib is a Tyk2 inhibitor being studied in clinical trials for various conditions, including Central Centrifugal Cicatricial Alopecia, Lichen Planopilaris, Ulcerative Colitis, and Systemic Lupus Erythematosus. It is also being compared to a placebo in these trials, which are assessing its safety and biomarker responses.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Tyk2 inhibitor |
|---|---|
| Sponsor | Usynova Pharmaceuticals Ltd. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Safety and Biomarker Responses of Delgocitinib (JAK1,2,3/TYK2 Inhibitor) in Central Centrifugal Cicatricial Alopecia and Lichen Planopilaris (PHASE2)
- A Clinical Study to Evaluate the Efficacy and Safety of D-2570 in the Treatment of Moderate to Severe Plaque Psoriasis. (PHASE3)
- Single and Multiple Dose and Food Effect Study to Evaluate the Safety, Tolerability and Pharmacokinetics of D-2570 Tablets in Healthy Subjects (PHASE1)
- A Study to Evaluate Effectiveness and Safety of BMS-986322 in Participants With Moderate-to-Severe Psoriasis (PHASE2)
- A Study to Evaluate Effectiveness and Safety of a TYK2 Inhibitor in Subjects With Moderate to Severe Plaque Psoriasis (NA)
- A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis (PHASE3)
- SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY)
- The Efficacy and Safety of Deucravacitinib in Takayasu's Arteritis (PHASE4)
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:
- Tyk2 inhibitor CI brief — competitive landscape report
- Tyk2 inhibitor updates RSS · CI watch RSS
- Usynova Pharmaceuticals Ltd. portfolio CI
Frequently asked questions about Tyk2 inhibitor
What is Tyk2 inhibitor?
Who makes Tyk2 inhibitor?
What development phase is Tyk2 inhibitor in?
Related
- Manufacturer: Usynova Pharmaceuticals Ltd. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing