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Traclear
Traclear is a Small molecule drug developed by Hanmi Pharmaceutical Company Limited. It is currently in Phase 1 development. Also known as: Traclear 62.5 mg.
Traclear is a medication being studied for Pulmonary Arterial Hypertension. It is also the subject of a clinical trial comparing its pharmacokinetics to HGP1206 in healthy male volunteers.
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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 | Traclear |
|---|---|
| Also known as | Traclear 62.5 mg |
| Sponsor | Hanmi Pharmaceutical Company Limited |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
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:
- Traclear CI brief — competitive landscape report
- Traclear updates RSS · CI watch RSS
- Hanmi Pharmaceutical Company Limited portfolio CI
Frequently asked questions about Traclear
What is Traclear?
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What development phase is Traclear in?
Related
- Manufacturer: Hanmi Pharmaceutical Company Limited — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Traclear 62.5 mg
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing