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MCS-2 soft-gel capsule
MCS-2 soft-gel capsule is a Small molecule drug developed by Health Ever Bio-Tech Co., Ltd.. It is currently in Phase 1 development. Also known as: MUS.
MCS-2 is a soft-gel capsule being studied in clinical trials for the treatment of Lower Urinary Tract Symptoms and Benign Prostatic Hyperplasia. The exact mechanism of action of MCS-2 is not specified in the provided information, but it is being investigated in a Phase III clinical trial.
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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 | MCS-2 soft-gel capsule |
|---|---|
| Also known as | MUS |
| Sponsor | Health Ever Bio-Tech Co., Ltd. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Efficacy and Safety of MCS-2 in the Treatment of Lower Urinary Tract Symptoms (PHASE3)
- Open-Label Extension Study of MCS-2 in the Treatment of Lower Urinary Tract Symptoms (PHASE3)
- MCS in the Treatment of Lower Urinary Tract Symptoms (PHASE2, PHASE3)
- Open-Label Extension Study of MCS-2 in the Treatment of Lower Urinary Tract Symptoms (MCS-2-US-c) (PHASE3)
- Pharmacokinetics of MCS in Healthy Volunteers (PHASE1)
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:
- MCS-2 soft-gel capsule CI brief — competitive landscape report
- MCS-2 soft-gel capsule updates RSS · CI watch RSS
- Health Ever Bio-Tech Co., Ltd. portfolio CI
Frequently asked questions about MCS-2 soft-gel capsule
What is MCS-2 soft-gel capsule?
Who makes MCS-2 soft-gel capsule?
Is MCS-2 soft-gel capsule also known as anything else?
What development phase is MCS-2 soft-gel capsule in?
Related
- Manufacturer: Health Ever Bio-Tech Co., Ltd. — full pipeline
- Also known as: MUS
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing