Last reviewed · How we verify
GST-HG171
GST-HG171 is a Small molecule drug developed by Fujian Akeylink Biotechnology Co., Ltd.. It is currently in Phase 1 development.
-
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 | GST-HG171 |
|---|---|
| Sponsor | Fujian Akeylink Biotechnology Co., Ltd. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Pharmacokinetics and Safety of GST-HG171 Tablets in Subjects With Impaired and Normal Renal Function (NA)
- Pharmacokinetics and Safety of GST-HG171 Tablets in Subjects With Impaired and Normal Liver Function (PHASE1)
- Drug-Drug Interaction Study of Itraconazole With GST-HG171/Ritonavir in Healthy Participants (PHASE1)
- Food Effects of GST-HG171 Tablets Combined With Ritonavir in Healthy Chinese Participants (PHASE1)
- Safety, Tolerability and Pharmacokinetic Characteristics Evaluation on GST-HG171 Tablets (PHASE1)
- Study of GST-HG171/Ritonavir Compared With Placebo in Patients With Mild to Moderate COVID-19 (PHASE2, 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:
- GST-HG171 CI brief — competitive landscape report
- GST-HG171 updates RSS · CI watch RSS
- Fujian Akeylink Biotechnology Co., Ltd. portfolio CI
Frequently asked questions about GST-HG171
What is GST-HG171?
Who makes GST-HG171?
What development phase is GST-HG171 in?
Related
- Manufacturer: Fujian Akeylink Biotechnology Co., Ltd. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing