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AK0529
AK0529 is a selective inhibitor of fibroblast growth factor receptor (FGFR) that blocks aberrant FGFR signaling in cancer cells.
AK0529 is a selective inhibitor of fibroblast growth factor receptor (FGFR) that blocks aberrant FGFR signaling in cancer cells. Used for FGFR-altered solid tumors (Phase 3 development).
At a glance
| Generic name | AK0529 |
|---|---|
| Also known as | AK0529 pellets, ziresovir, Ziresovir, AK0529 capsule |
| Sponsor | Shanghai Ark Biopharmaceutical Co., Ltd. |
| Drug class | FGFR inhibitor |
| Target | FGFR (Fibroblast Growth Factor Receptor) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
AK0529 targets FGFR, a receptor tyrosine kinase frequently dysregulated in various solid tumors through gene amplification, mutation, or translocation. By inhibiting FGFR signaling, the drug suppresses tumor cell proliferation and survival pathways. This mechanism is particularly relevant in cancers with FGFR alterations, including certain lung, gastric, and other solid malignancies.
Approved indications
- FGFR-altered solid tumors (Phase 3 development)
Common side effects
- Hyperphosphatemia
- Diarrhea
- Fatigue
- Nausea
Key clinical trials
- A Study of AK0529 in Adults Patients Hospitalized With RSV Infection (PHASE2)
- A Study to Confirm the Effectiveness and Safety of AK0529 in Treating RSV Infections in Hospitalized Infants (PHASE3)
- Viral Inhibition in Children for Treatment of RSV (PHASE2)
- A Study of AK0529 in Chinese Infants Hospitalized With RSV (PHASE3)
- A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Ziresovir in Healthy Subjects (PHASE1)
- A Study of AK0529 to Evaluate Pharmacokinetics and Safety in Chinese Healthy Volunteers (PHASE1)
- Anti-RSV Study in Chinese Patients (ASCENT) (PHASE2)
- A Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of AK0529 (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:
- AK0529 CI brief — competitive landscape report
- AK0529 updates RSS · CI watch RSS
- Shanghai Ark Biopharmaceutical Co., Ltd. portfolio CI