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Penlac
Penlac is a Small molecule drug developed by 9305-9954 Quebec Inc. It is currently in Phase 2 development for Candidiasis of skin, Onychomycosis due to dermatophyte, Pityriasis simplex. Also known as: topical Penlac nail lacquer.
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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 | Penlac |
|---|---|
| Also known as | topical Penlac nail lacquer |
| Sponsor | 9305-9954 Quebec Inc |
| Target | Deoxyhypusine hydroxylase, Poly [ADP-ribose] polymerase 1 |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 2 |
Approved indications
- Candidiasis of skin
- Onychomycosis due to dermatophyte
- Pityriasis simplex
- Pityriasis versicolor
- Seborrheic dermatitis
- Tinea corporis
- Tinea cruris
- Tinea pedis
Common side effects
Key clinical trials
- A Study to Investigate the Improvement of Photosensitivity in Terms of Skin Lesions Associated With CEP Following Administration of Oral ATL-001 (Ciclopirox Oral Solution) in Participants Aged >18 Years of Age With CEP (PHASE1, PHASE2)
- Study in Patients With Onychomycosis Treated With Mycoclear® and Ciclopirox
- Study to Assess the Safety and Pharmacokinetics of ATL-001 (Ciclopirox Olamine) in Healthy Volunteers (PHASE1)
- Photodynamic Therapy and Topical Antifungal for Onychomycosis in Patients With Diabetes. (NA)
- Mycosis Culture Collection From Dermatological Isolated
- Diode Laser and Photodynamic Therapy Vs. Ciclopirox. (PHASE4)
- Safety and Equivalence of a Generic Ciclopirox Olamine Topical Suspension Compared to the Reference Ciclopirox Topical Suspension 0.77% for the Treatment of Tinea Pedis (NA)
- Safety and Equivalence of a Generic Ciclopirox Olamine Cream Compared to the Reference Ciclopirox Cream 0.77% for the Treatment of Tinea Pedis (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:
- Penlac CI brief — competitive landscape report
- Penlac updates RSS · CI watch RSS
- 9305-9954 Quebec Inc portfolio CI
Frequently asked questions about Penlac
What is Penlac?
What is Penlac used for?
Who makes Penlac?
Is Penlac also known as anything else?
What development phase is Penlac in?
What does Penlac target?
Related
- Target: All drugs targeting Deoxyhypusine hydroxylase, Poly [ADP-ribose] polymerase 1
- Manufacturer: 9305-9954 Quebec Inc — full pipeline
- Therapeutic area: All drugs in Dermatology
- Indication: Drugs for Candidiasis of skin
- Indication: Drugs for Onychomycosis due to dermatophyte
- Indication: Drugs for Pityriasis simplex
- Also known as: topical Penlac nail lacquer
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing