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Merlin
Merlin is a Small molecule drug developed by Topical Remedy. It is currently in Phase 2 development.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Merlin |
|---|---|
| Sponsor | Topical Remedy |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Insertable Cardiac Monitor for Primary Atrial Fibrillation Detection in High-Risk Heart Failure Patients (NA)
- A Phase II Clinical Trial on Neo-adjuvant Pembrolizumab in Patients With pT3b-T4a/b cN0M0 Melanoma. (PHASE2)
- Assessing Sensor-Guided Compression Therapy for Venous Leg Ulcers Healing Outcomes (NA)
- A Trial of Bardoxolone Methyl in Patients With CKD at Risk of Rapid Progression (MERLIN) (PHASE2)
- The MAR Method Versus the Visual Estimation Method in Predicting External Blood Loss (NA)
- Gene Therapy for Neurofibromatosis Type 2 (NF2) with ST002 (NA)
- Atrial Anomalies Predict Silent Atrial Fibrillation Detected by Implantable Cardiac Monitor in Cryptogenic Stroke (NA)
- MElanoma Research Lymph Node Prediction Implementation National_001
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:
- Merlin CI brief — competitive landscape report
- Merlin updates RSS · CI watch RSS
- Topical Remedy portfolio CI
Frequently asked questions about Merlin
What is Merlin?
Who makes Merlin?
What development phase is Merlin in?
Related
- Manufacturer: Topical Remedy — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing