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SPH3127 tablet Dose 1
SPH3127 tablet Dose 1 is a Small molecule drug developed by Shanghai Pharmaceuticals Holding Co., Ltd. It is currently in Phase 3 development. Also known as: renion inhibitor, renion inhibitor placebo.
SPH3127 tablet Dose 1 is a drug with an unknown mechanism of action.
SPH3127 is a small molecule renin inhibitor used in the treatment of Diabetic Kidney Disease and Hypertension. It is being studied in a Phase 2 clinical trial to evaluate its efficacy and safety in patients with Diabetic Kidney Disease.
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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 | SPH3127 tablet Dose 1 |
|---|---|
| Also known as | renion inhibitor, renion inhibitor placebo |
| Sponsor | Shanghai Pharmaceuticals Holding Co., Ltd |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
Unfortunately, there is limited information available about the mechanism of action of SPH3127 tablet Dose 1.
Approved indications
Common side effects
Key clinical trials
- Efficacy and Safety of SPH3127 Tablets on Treating the Diabetic Kidney Disease (PHASE2)
- Single Ascending Dose Study of Safety and Tolerability of SPH3127 Tablet in Chinese Healthy Volunteers (PHASE1)
- Drug-drug Interaction Study of SPH3127 (PHASE1, PHASE2)
- Safety and Efficacy of SPH3127 on Treating Mild-moderate Essential Hypertension Patients (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:
- SPH3127 tablet Dose 1 CI brief — competitive landscape report
- SPH3127 tablet Dose 1 updates RSS · CI watch RSS
- Shanghai Pharmaceuticals Holding Co., Ltd portfolio CI
Frequently asked questions about SPH3127 tablet Dose 1
What is SPH3127 tablet Dose 1?
How does SPH3127 tablet Dose 1 work?
Who makes SPH3127 tablet Dose 1?
Is SPH3127 tablet Dose 1 also known as anything else?
What development phase is SPH3127 tablet Dose 1 in?
Related
- Manufacturer: Shanghai Pharmaceuticals Holding Co., Ltd — full pipeline
- Also known as: renion inhibitor, renion inhibitor placebo
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing