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Ciclopirox Olamine Oral
Ciclopirox Olamine Oral is a Broad-spectrum antifungal Small molecule drug developed by Atlas Molecular Pharma. It is currently in Phase 3 development for Onychomycosis (fungal nail infection), Systemic fungal infections.
Ciclopirox olamine is a broad-spectrum antifungal agent that inhibits fungal cytochrome P450 enzymes and disrupts fungal cell membrane integrity.
Ciclopirox olamine is a broad-spectrum antifungal agent that inhibits fungal cytochrome P450 enzymes and disrupts fungal cell membrane integrity. Used for Onychomycosis (fungal nail infection), Systemic fungal infections.
At a glance
| Generic name | Ciclopirox Olamine Oral |
|---|---|
| Sponsor | Atlas Molecular Pharma |
| Drug class | Broad-spectrum antifungal |
| Target | Fungal cytochrome P450 enzymes (iron/aluminum chelation) |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Dermatology |
| Phase | Phase 3 |
Mechanism of action
Ciclopirox olamine chelates polyvalent cations (iron and aluminum) that are essential cofactors for fungal cytochrome P450 enzymes, thereby inhibiting critical metabolic pathways. This mechanism disrupts fungal cell membrane and cell wall synthesis, leading to fungistatic and fungicidal activity against a wide range of dermatophytes, yeasts, and other fungi. The oral formulation extends systemic antifungal activity beyond topical application.
Approved indications
- Onychomycosis (fungal nail infection)
- Systemic fungal infections
Common side effects
- Gastrointestinal disturbances (nausea, diarrhea)
- Headache
- Elevated liver enzymes
- Abdominal pain
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 to Assess the Safety and Pharmacokinetics of ATL-001 (Ciclopirox Olamine) in Healthy Volunteers (PHASE1)
- Mycosis Culture Collection From Dermatological Isolated
- Study Evaluating the Tolerance and Biologic Activity of Oral Ciclopirox Olamine in Patients With Relapsed or Refractory Hematologic Malignancy (PHASE1)
- Efficacy and Safety of Low-dose Oral Isotretinoin for Seborrhea (PHASE4)
- Selenium Sulfide, Ketoconazole and Ciclopirox Shampoo as Additional Treatments for Tinea Capitis (Scalp Ringworm) (NA)
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:
- Ciclopirox Olamine Oral CI brief — competitive landscape report
- Ciclopirox Olamine Oral updates RSS · CI watch RSS
- Atlas Molecular Pharma portfolio CI
Frequently asked questions about Ciclopirox Olamine Oral
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Related
- Drug class: All Broad-spectrum antifungal drugs
- Target: All drugs targeting Fungal cytochrome P450 enzymes (iron/aluminum chelation)
- Manufacturer: Atlas Molecular Pharma — full pipeline
- Therapeutic area: All drugs in Infectious Disease / Dermatology
- Indication: Drugs for Onychomycosis (fungal nail infection)
- Indication: Drugs for Systemic fungal infections
- Compare: Ciclopirox Olamine Oral vs similar drugs
- Pricing: Ciclopirox Olamine Oral cost, discount & access