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KPS-0373, Low dose
KPS-0373, Low dose is a SGLT2 inhibitor Small molecule drug developed by Kissei Pharmaceutical Co., Ltd.. It is currently in Phase 3 development for Type 2 diabetes mellitus.
KPS-0373 is a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor that reduces blood glucose by promoting urinary glucose excretion.
KPS-0373 is a small molecule thyrotropin-releasing hormone receptor agonist, classified as an agonist. It has been studied in a completed clinical trial (NCT01970124) for the treatment of spinocerebellar degeneration.
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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 | KPS-0373, Low dose |
|---|---|
| Sponsor | Kissei Pharmaceutical Co., Ltd. |
| Drug class | SGLT2 inhibitor |
| Target | SGLT2 |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 3 |
Mechanism of action
SGLT2 inhibitors block the reabsorption of filtered glucose in the proximal tubule of the kidney, leading to increased urinary glucose excretion and lower blood glucose levels. This mechanism is independent of insulin secretion and provides cardiovascular and renal protective benefits beyond glycemic control.
Approved indications
- Type 2 diabetes mellitus
Common side effects
- Genital mycotic infections
- Urinary tract infections
- Polyuria
- Polydipsia
Key clinical trials
- A Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD) (PHASE3)
- A 24-week Open-label Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD) (PHASE3)
- An Extension Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD) (PHASE3)
- A Long-Term Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD) (PHASE3)
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:
- KPS-0373, Low dose CI brief — competitive landscape report
- KPS-0373, Low dose updates RSS · CI watch RSS
- Kissei Pharmaceutical Co., Ltd. portfolio CI
Frequently asked questions about KPS-0373, Low dose
What is KPS-0373, Low dose?
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What is KPS-0373, Low dose used for?
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What drug class is KPS-0373, Low dose in?
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What are the side effects of KPS-0373, Low dose?
What does KPS-0373, Low dose target?
Related
- Drug class: All SGLT2 inhibitor drugs
- Target: All drugs targeting SGLT2
- Manufacturer: Kissei Pharmaceutical Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Diabetes
- Indication: Drugs for Type 2 diabetes mellitus
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing