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Long-term Dosing Cohort
Long-term Dosing Cohort is a Small molecule drug developed by Shaanxi Micot Pharmaceutical Technology Co., Ltd.. It is currently in Phase 2 development.
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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 | Long-term Dosing Cohort |
|---|---|
| Sponsor | Shaanxi Micot Pharmaceutical Technology Co., Ltd. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Study in Pediatric Participants With Congenital Adrenal Hyperplasia (Balance-CAH) (PHASE2, PHASE3)
- A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma (PHASE2)
- Perioperative TORIPALIMAB Plus LENVATINIB in Patients With Renal Cell Carcinoma Undergoing Nephrectomy (PLUTO) (PHASE2)
- REal-life ON PARKinson's - ITaly (REONPARK-IT)
- A Clinical Study Evaluating the Safety, Tolerability, and Efficacy of MT1013 in Hemodialysis Subjects With Secondary Hyperparathyroidism (PHASE2)
- Follitropin Delta in Long GnRH-agonist Protocol
- Evaluation of Safety, Tolerability, and Efficacy of INZ-701 in Adults With ENPP1 Deficiency (PHASE1, PHASE2)
- Evaluation of Safety, Tolerability, and Efficacy of INZ-701 in Adults With ABCC6 Deficiency Causing PXE (PHASE1, 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:
- Long-term Dosing Cohort CI brief — competitive landscape report
- Long-term Dosing Cohort updates RSS · CI watch RSS
- Shaanxi Micot Pharmaceutical Technology Co., Ltd. portfolio CI
Frequently asked questions about Long-term Dosing Cohort
What is Long-term Dosing Cohort?
Who makes Long-term Dosing Cohort?
What development phase is Long-term Dosing Cohort in?
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing