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HP518 - Dose Escalation
HP518 - Dose Escalation is a Small molecule drug developed by Hinova Pharmaceuticals Aus Pty Ltd. It is currently in Phase 1 development. Also known as: Part 1 - Dose Escalation.
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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 | HP518 - Dose Escalation |
|---|---|
| Also known as | Part 1 - Dose Escalation |
| Sponsor | Hinova Pharmaceuticals Aus Pty Ltd |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Study to Assess the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral HP518 in mCRPC Patients (PHASE1, PHASE2)
- A Study to Assess the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral HP518 in Patients With Metastatic Castration-Resistant Prostate Cancer (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:
- HP518 - Dose Escalation CI brief — competitive landscape report
- HP518 - Dose Escalation updates RSS · CI watch RSS
- Hinova Pharmaceuticals Aus Pty Ltd portfolio CI
Frequently asked questions about HP518 - Dose Escalation
What is HP518 - Dose Escalation?
Who makes HP518 - Dose Escalation?
Is HP518 - Dose Escalation also known as anything else?
What development phase is HP518 - Dose Escalation in?
Related
- Manufacturer: Hinova Pharmaceuticals Aus Pty Ltd — full pipeline
- Also known as: Part 1 - Dose Escalation
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing