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Drug: SHR0302
Drug: SHR0302 is a SGLT2 inhibitor Small molecule drug developed by Reistone Biopharma Company Limited. It is currently in Phase 2 development for Type 2 diabetes.
SHR0302 is a small molecule that targets the SGLT2 receptor.
SHR0302 is a small molecule that targets the SGLT2 receptor. Used for Type 2 diabetes.
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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 | Drug: SHR0302 |
|---|---|
| Sponsor | Reistone Biopharma Company Limited |
| Drug class | SGLT2 inhibitor |
| Target | SGLT2 |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 2 |
Mechanism of action
By inhibiting SGLT2, SHR0302 reduces glucose reabsorption in the kidneys, thereby lowering blood glucose levels. This makes it a potential treatment for type 2 diabetes.
Approved indications
- Type 2 diabetes
Common side effects
- Increased risk of diabetic ketoacidosis
Key clinical trials
- A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Rheumatoid Arthritis (PHASE3)
- Evaluate the Efficacy and Safety of Topical SHR0302 Ointment in Patients With Mild-to-Moderate Atopic Dermatitis (PHASE2, PHASE3)
- Evaluate the Efficacy and Safety of SHR0302 in Adult Patients With Severe Alopecia Areata (PHASE3)
- Evaluate the Efficacy and Safety of SHR1459 Tablets in Patients With Primary Membranous Nephropathy (PHASE2)
- A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis. (PHASE2)
- Evaluate Efficacy and Safety of Oral SHR0302 in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis (PHASE3)
- A Phase II Study in Adult Patients With Moderate to Severe Atopic Dermatitis (PHASE2)
- A Phase II Study in Patients With Moderate to Severe Active Crohn's Disease (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:
- Drug: SHR0302 CI brief — competitive landscape report
- Drug: SHR0302 updates RSS · CI watch RSS
- Reistone Biopharma Company Limited portfolio CI
Frequently asked questions about Drug: SHR0302
What is Drug: SHR0302?
How does Drug: SHR0302 work?
What is Drug: SHR0302 used for?
Who makes Drug: SHR0302?
What drug class is Drug: SHR0302 in?
What development phase is Drug: SHR0302 in?
What are the side effects of Drug: SHR0302?
What does Drug: SHR0302 target?
Related
- Drug class: All SGLT2 inhibitor drugs
- Target: All drugs targeting SGLT2
- Manufacturer: Reistone Biopharma Company Limited — full pipeline
- Therapeutic area: All drugs in Diabetes
- Indication: Drugs for Type 2 diabetes
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing