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glucokinase activator
glucokinase activator is a Small molecule drug developed by PegBio Co., Ltd.. It is currently in Phase 1 development. Also known as: PB-201.
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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 | glucokinase activator |
|---|---|
| Also known as | PB-201 |
| Sponsor | PegBio Co., Ltd. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes (PHASE3)
- Effects of Modulators of Gluconeogenesis, Glycogenolysis and Glucokinase Activity (PHASE3)
- Glucokinase Activator in Monogenic Diabetes (PHASE2)
- Drug Interaction Study Between Dorzagliatin and Empagliflozin (PHASE1)
- Chronic Dorzagliatin on Insulin and Incretin Function in Intermediate Hyperglycemia and Type 2 Diabetes (NA)
- Drug Interaction Study Between Dorzagliatin and Sitagliptin (PHASE1)
- Long-term Efficacy and Safety of HMS5552 in T2DM Subjects (PHASE3)
- The Progress of Diabetes Mellitus After HMS5552 Treatment in Type 2 Diabetes Mellitus
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:
- glucokinase activator CI brief — competitive landscape report
- glucokinase activator updates RSS · CI watch RSS
- PegBio Co., Ltd. portfolio CI
Frequently asked questions about glucokinase activator
What is glucokinase activator?
Who makes glucokinase activator?
Is glucokinase activator also known as anything else?
What development phase is glucokinase activator in?
Related
- Manufacturer: PegBio Co., Ltd. — full pipeline
- Also known as: PB-201
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing