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LNK01001 Dose B
LNK01001 Dose B is a Small molecule drug developed by Lynk Pharmaceuticals Co., Ltd. It is currently in Phase 2 development.
LNK01001 Dose B is a small molecule intervention being studied in clinical trials for Ankylosing Spondylitis, Rheumatoid Arthritis, and Atopic Dermatitis. It is a formulation of LNK01001, which contains cotinine as 15% of its dose.
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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).
| 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 | LNK01001 Dose B |
|---|---|
| Sponsor | Lynk Pharmaceuticals Co., Ltd |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Study of LNK01001 Capsule in Patients With Ankylosing Spondylitis (PHASE2)
- A Study of LNK01001 Capsule in Patients With Moderate to Severe Atopic Dermatitis (PHASE2)
- A Study of LNK01001 Capsule in Moderately to Severely Active Rheumatoid Arthritis (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:
- LNK01001 Dose B CI brief — competitive landscape report
- LNK01001 Dose B updates RSS · CI watch RSS
- Lynk Pharmaceuticals Co., Ltd portfolio CI
Frequently asked questions about LNK01001 Dose B
What is LNK01001 Dose B?
Who makes LNK01001 Dose B?
What development phase is LNK01001 Dose B in?
Related
- Manufacturer: Lynk Pharmaceuticals Co., Ltd — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing