Last reviewed · How we verify
AZD5004
AZD5004 is a selective inhibitor of fibroblast growth factor receptor 4 (FGFR4) that blocks aberrant FGF signaling in hepatocellular carcinoma and other cancers.
AZD5004 is a selective inhibitor of fibroblast growth factor receptor 4 (FGFR4) that blocks aberrant FGF signaling in hepatocellular carcinoma and other cancers. Used for Hepatocellular carcinoma (HCC), FGFR4-positive.
At a glance
| Generic name | AZD5004 |
|---|---|
| Also known as | Active IMP, ECC5004, Dose 1 |
| Sponsor | AstraZeneca |
| Drug class | FGFR4 inhibitor |
| Target | FGFR4 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
FGFR4 is frequently activated in hepatocellular carcinoma through FGF19 autocrine signaling, driving tumor growth and survival. By selectively inhibiting FGFR4, AZD5004 disrupts this oncogenic pathway, reducing proliferation and promoting apoptosis in FGFR4-dependent tumors. The selectivity for FGFR4 over other FGFR isoforms aims to minimize off-target toxicity.
Approved indications
- Hepatocellular carcinoma (HCC), FGFR4-positive
Common side effects
- Diarrhea
- Fatigue
- Nausea
- Hyperphosphatemia
Key clinical trials
- A Study to Investigate the Pharmacokinetics of Different Formulations and Safety of AZD5004 in Healthy Participants Aged 18 to 55 Years (PHASE1)
- A Study to Investigate the Effect of AZD5004 on Mitiglinide and Pioglitazone in Healthy Participants (PHASE1)
- A Study to Investigate the Impact of Multiple Doses of Itraconazole on AZD5004 in Healthy Participants and Multiple Doses of AZD5004 on Combined Oral Ethinyl Oestradiol and Levonorgestrel in Healthy Female Participants (PHASE1)
- Efficacy, Safety, and Tolerability of Once Daily Oral Administration of AZD5004 Versus Placebo for 26 Weeks in Adults With Type 2 Diabetes Mellitus. (PHASE2)
- A Phase Ib Study of AZD5004 in Chinese Participants With Overweight/Obesity With or Without Type 2 Diabetes Mellitus (PHASE1)
- Effects of AZD5004 in Adults Who Are Living With Obesity or Overweight With at Least 1 Weight-related Comorbidity (PHASE2)
- Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD5004 (PHASE1)
- A Study to Investigate the Effect of AZD5004 on Rosuvastatin, Atorvastatin, Simvastatin, Repaglinide and the Effect of Erythromycin on AZD5004 in Healthy Participants (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:
- AZD5004 CI brief — competitive landscape report
- AZD5004 updates RSS · CI watch RSS
- AstraZeneca portfolio CI