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Danggui-Sini granules
Danggui-Sini granules is a Small molecule drug developed by Nanjing NingQi Medicine Science and Technology Co., Ltd.. It is currently in Phase 3 development for Cold-related pain conditions, Peripheral circulatory dysfunction, Raynaud's phenomenon or similar cold extremity conditions.
Danggui-Sini granules is a traditional Chinese medicine formulation that promotes blood circulation and warms the meridians to treat cold-related pain and circulatory dysfunction.
Danggui-Sini granules is a traditional Chinese medicine formulation that promotes blood circulation and warms the meridians to treat cold-related pain and circulatory dysfunction. Used for Cold-related pain conditions, Peripheral circulatory dysfunction, Raynaud's phenomenon or similar cold extremity conditions.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Danggui-Sini granules |
|---|---|
| Sponsor | Nanjing NingQi Medicine Science and Technology Co., Ltd. |
| Modality | Small molecule |
| Therapeutic area | Pain Management / Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
This herbal granule combines multiple traditional Chinese medicinal ingredients, primarily Angelica sinensis (Danggui) and other warming herbs, to improve microcirculation and alleviate symptoms associated with qi and blood stagnation in cold conditions. The formulation is believed to work by enhancing peripheral blood flow and reducing pain through traditional mechanisms of warming interior cold and unblocking meridians.
Approved indications
- Cold-related pain conditions
- Peripheral circulatory dysfunction
- Raynaud's phenomenon or similar cold extremity conditions
Common side effects
- Gastrointestinal upset
- Allergic reactions
Key clinical trials
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:
- Danggui-Sini granules CI brief — competitive landscape report
- Danggui-Sini granules updates RSS · CI watch RSS
- Nanjing NingQi Medicine Science and Technology Co., Ltd. portfolio CI
Frequently asked questions about Danggui-Sini granules
What is Danggui-Sini granules?
How does Danggui-Sini granules work?
What is Danggui-Sini granules used for?
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Related
- Manufacturer: Nanjing NingQi Medicine Science and Technology Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Pain Management / Cardiovascular
- Indication: Drugs for Cold-related pain conditions
- Indication: Drugs for Peripheral circulatory dysfunction
- Indication: Drugs for Raynaud's phenomenon or similar cold extremity conditions
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing