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HRS-7535 Tablets
HRS-7535 Tablets is a Small molecule drug developed by Shandong Suncadia Medicine Co., Ltd.. It is currently in Phase 3 development.
HRS-7535 is an investigational small molecule with unknown mechanism of action in Phase 3 development.
HRS-7535 tablets are being studied in clinical trials for their efficacy and safety in treating patients with mild decrease in ejection fraction/preserved ejection fraction heart failure and obesity. The trials are also comparing HRS-7535 tablets to a placebo and dapagliflozin tablets in patients with various conditions including type 2 diabetes and obesity.
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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).
| 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 | HRS-7535 Tablets |
|---|---|
| Sponsor | Shandong Suncadia Medicine Co., Ltd. |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
Limited public information is available regarding the specific molecular mechanism of HRS-7535. As a Phase 3 candidate from Shandong Suncadia Medicine Co., Ltd., the drug is in late-stage clinical development, but detailed mechanistic data has not been widely disclosed in accessible pharmaceutical databases or literature.
Approved indications
Common side effects
Key clinical trials
- Efficacy and Safety of HRS-7535 Tablets in Adults With Diabetic Kidney Disease in Type 2 Diabetes (PHASE2)
- A Study to Evaluate the Drug Interactions of HRS-7535 With Acetaminophen, Digoxin, Rosuvastatin, and Omeprazole in Obese or Overweight Subjects (PHASE1)
- Study on the Efficacy and Safety of HRS-7535 in Patients With Mild Decrease in Ejection Fraction/Preserved Ejection Fraction Heart Failure and Obesity (PHASE2)
- Efficacy and Safety of HRS-7535 Tablets in T2DM Subjects Poorly Controlled With Metformin and SGLT2i. (PHASE2)
- Long-term Efficacy and Safety of HRS-7535 Tablets in Obese Subjects (PHASE2)
- A Trial of HRS-7535 Tablets in Subjects With Overweight or Obesity (PHASE3)
- A Study of HRS-7535 Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequately Controlled With Diet and Exercise (PHASE3)
- A Study of Safety and Tolerability of Multiple Doses of HRS-7535 in Obese Subjects (PHASE1, 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:
- HRS-7535 Tablets CI brief — competitive landscape report
- HRS-7535 Tablets updates RSS · CI watch RSS
- Shandong Suncadia Medicine Co., Ltd. portfolio CI
Frequently asked questions about HRS-7535 Tablets
What is HRS-7535 Tablets?
How does HRS-7535 Tablets work?
Who makes HRS-7535 Tablets?
What development phase is HRS-7535 Tablets in?
Related
- Manufacturer: Shandong Suncadia Medicine Co., Ltd. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing