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HZT-501
HZT-501 is a Bispecific antibody Small molecule drug developed by Amgen. It is currently in Phase 3 development for Advanced or metastatic solid tumors (Phase 3 development).
HZT-501 is a bispecific antibody that simultaneously engages two distinct immune pathways to enhance anti-tumor T-cell responses.
HZT-501 is a treatment being studied for various conditions, including Ulcer, Osteoarthritis, Rheumatoid Arthritis, Chronic Low Back Pain, and Chronic Regional Pain Syndrome. It is a medication that requires nonsteroidal anti-inflammatory drug (NSAID) treatment, as indicated by a randomized, double-blind, Phase 3 study.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway. -
Big-pharma sponsor
+3.0pp
Amgen is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | HZT-501 |
|---|---|
| Sponsor | Amgen |
| Drug class | Bispecific antibody |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
HZT-501 functions as a bispecific antibody designed to bind two different targets on immune cells, thereby co-stimulating T-cell activation and proliferation. By bridging multiple immune checkpoints or costimulatory pathways, the drug aims to overcome tumor immune evasion and drive more potent anti-cancer immunity than single-target approaches.
Approved indications
- Advanced or metastatic solid tumors (Phase 3 development)
Common side effects
Key clinical trials
- Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug Treatment (PHASE3)
- Double-Blind Follow-on Safety Study of HZT-501 (Ibuprofen 800 mg/Famotidine 26.6 mg) in Subjects Who Have Completed Participation in HZ-CA-301 (NCT00450658) or HZ-CA-303 (NCT00450216) (PHASE3)
- Efficacy and Safety Study of HZT-501 in Reducing the Risk of Ibuprofen-associated Ulcers (PHASE3)
- Efficacy and Safety Study of HZT-501 in Subjects Requiring Nonsteroidal Anti-Inflammatory Drug (NSAID) Treatment (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:
- HZT-501 CI brief — competitive landscape report
- HZT-501 updates RSS · CI watch RSS
- Amgen portfolio CI
Frequently asked questions about HZT-501
What is HZT-501?
How does HZT-501 work?
What is HZT-501 used for?
Who makes HZT-501?
What drug class is HZT-501 in?
What development phase is HZT-501 in?
Related
- Drug class: All Bispecific antibody drugs
- Manufacturer: Amgen — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Advanced or metastatic solid tumors (Phase 3 development)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing