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GST-HG131
GST-HG131 is a HIF-1α inhibitor Small molecule drug developed by Fujian Akeylink Biotechnology Co., Ltd.. It is currently in Phase 2 development for Advanced solid tumors.
GST-HG131 is a small molecule targeting the HIF-1α pathway.
GST-HG131 is a small molecule targeting the HIF-1α pathway. Used for Advanced solid tumors.
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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). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
| 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 | GST-HG131 |
|---|---|
| Sponsor | Fujian Akeylink Biotechnology Co., Ltd. |
| Drug class | HIF-1α inhibitor |
| Target | HIF-1α |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
GST-HG131 works by inhibiting the interaction between HIF-1α and p300, thereby reducing the transcription of genes involved in angiogenesis and tumor growth.
Approved indications
- Advanced solid tumors
Common side effects
- Fatigue
- Nausea
- Diarrhea
Key clinical trials
- A Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Study to Evaluate the Safety and Efficacy of GST-HG131 Tablets in Patients With Chronic Hepatitis B (PHASE2)
- Safety, Tolerability and Pharmacokinetic Characteristics Evaluation of GST-HG131 Tablets (PHASE1)
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:
- GST-HG131 CI brief — competitive landscape report
- GST-HG131 updates RSS · CI watch RSS
- Fujian Akeylink Biotechnology Co., Ltd. portfolio CI
Frequently asked questions about GST-HG131
What is GST-HG131?
How does GST-HG131 work?
What is GST-HG131 used for?
Who makes GST-HG131?
What drug class is GST-HG131 in?
What development phase is GST-HG131 in?
What are the side effects of GST-HG131?
What does GST-HG131 target?
Related
- Drug class: All HIF-1α inhibitor drugs
- Target: All drugs targeting HIF-1α
- Manufacturer: Fujian Akeylink Biotechnology Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Advanced solid tumors
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing