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Shengmai capsule
Shengmai capsule is a Small molecule drug developed by Beijing University of Chinese Medicine. It is currently in Phase 2 development.
Shengmai capsule is a small molecule that acts as a neurokinin 1 receptor antagonist. It has been studied in various clinical trials for conditions such as intradialytic hypotension, ischemic strokes, and cancer patients undergoing chemotherapy or radiotherapy.
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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 | Shengmai capsule |
|---|---|
| Sponsor | Beijing University of Chinese Medicine |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- The Clinical Study of Improving the Thirst and Hypotension of Hemodialysis Patients (PHASE2, PHASE3)
- The Secondary Prevention Trial for Ischemic Stroke With DengzhanShengmai Capsule (PHASE4)
- Therapeutic Effects of Traditional Chinese Medicine, Shen-Mai San in Cancer Patient Undergoing Chemotherapy or Radiotherapy (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:
- Shengmai capsule CI brief — competitive landscape report
- Shengmai capsule updates RSS · CI watch RSS
- Beijing University of Chinese Medicine portfolio CI
Frequently asked questions about Shengmai capsule
What is Shengmai capsule?
Who makes Shengmai capsule?
What development phase is Shengmai capsule in?
Related
- Manufacturer: Beijing University of Chinese Medicine — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing