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HRS-9531 Tablet
HRS-9531 Tablet is a Small molecule drug developed by Fujian Shengdi Pharmaceutical Co., Ltd.. It is currently in Phase 1 development.
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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 | HRS-9531 Tablet |
|---|---|
| Sponsor | Fujian Shengdi Pharmaceutical Co., Ltd. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Relative Bioavailability of First vs Second-Generation Formulations of HRS9531 Tablets in Obese or Overweight Subjects (PHASE1)
- Efficacy and Safety of HRS9531 Tablet in Obese Subjects (PHASE2)
- A Study of Single and Multiple Doses HRS9531 Tablets in Healthy Subjects (PHASE1)
- Influence of HRS9531 on Pharmacokinetics of Metformin in Healthy Subjects (PHASE1)
- Investigation of Optimal Dosage Regimen for HRS9531 Tablets in Healthy Subjects (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:
- HRS-9531 Tablet CI brief — competitive landscape report
- HRS-9531 Tablet updates RSS · CI watch RSS
- Fujian Shengdi Pharmaceutical Co., Ltd. portfolio CI
Frequently asked questions about HRS-9531 Tablet
What is HRS-9531 Tablet?
Who makes HRS-9531 Tablet?
What development phase is HRS-9531 Tablet in?
Related
- Manufacturer: Fujian Shengdi Pharmaceutical Co., Ltd. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing