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HIP1601 40mg
HIP1601 40mg is a Small molecule drug developed by Hanmi Pharmaceutical Company Limited. It is currently in Phase 1 development. Also known as: HIP1601.
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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 | HIP1601 40mg |
|---|---|
| Also known as | HIP1601 |
| Sponsor | Hanmi Pharmaceutical Company Limited |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Food-effect on PK and PD of Single Oral Dose of HIP1601 in Healthy Subjects (PHASE1)
- Efficacy and Safety of HIP1601 Capsule (PHASE3)
- Food-effect on PK and PD of Single Oral Dose of HIP1601 in Healthy Male Subjects (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:
- HIP1601 40mg CI brief — competitive landscape report
- HIP1601 40mg updates RSS · CI watch RSS
- Hanmi Pharmaceutical Company Limited portfolio CI
Frequently asked questions about HIP1601 40mg
What is HIP1601 40mg?
Who makes HIP1601 40mg?
Is HIP1601 40mg also known as anything else?
What development phase is HIP1601 40mg in?
Related
- Manufacturer: Hanmi Pharmaceutical Company Limited — full pipeline
- Also known as: HIP1601
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing