Last reviewed · How we verify
Baycuten N®
Baycuten N® is a Topical corticosteroid with antimicrobial agent Small molecule drug developed by Ache Laboratorios Farmaceuticos S.A.. It is currently in Phase 3 development for Inflammatory skin conditions with secondary bacterial infection or infection risk (e.g., eczema, dermatitis, impetigo). Also known as: clotrimazole and dexamethasone acetate.
Baycuten N is a topical combination product containing a corticosteroid and an antimicrobial agent that reduces inflammation and prevents bacterial infection in skin conditions.
Baycuten N is a combination treatment that includes arsenic trioxide, ascorbic acid, and bortezomib. It has been studied in clinical trials for various blood cancers, including multiple myeloma, acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and plasma cell neoplasms.
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Baycuten N® |
|---|---|
| Also known as | clotrimazole and dexamethasone acetate |
| Sponsor | Ache Laboratorios Farmaceuticos S.A. |
| Drug class | Topical corticosteroid with antimicrobial agent |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 3 |
Mechanism of action
The formulation typically combines a potent topical corticosteroid (such as betamethasone) with an antimicrobial component (such as neomycin or gentamicin) to address inflammatory skin disorders complicated by or at risk of secondary bacterial infection. The corticosteroid suppresses local immune response and inflammation, while the antimicrobial component provides broad-spectrum bacterial coverage.
Approved indications
- Inflammatory skin conditions with secondary bacterial infection or infection risk (e.g., eczema, dermatitis, impetigo)
Common side effects
- Local skin irritation or sensitization
- Contact dermatitis
- Skin atrophy with prolonged use
Key clinical trials
- A Phase II Study of Vibecotamab (XmAb14045) for MRD- Positive AML and MDS After Hypomethylating Agent Failure (PHASE2)
- Wild-Type Reovirus, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma (PHASE1)
- Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma (PHASE3)
- Effectiveness Study of Ketoconazole and Betamethasone to Treat Fungal Infection and Dermatophytosis (PHASE3)
- Calaspargase Pegol or Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia (PHASE3)
- Arsenic Trioxide and Ascorbic Acid Combined With Bortezomib, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma or Plasma Cell Leukemia (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:
- Baycuten N® CI brief — competitive landscape report
- Baycuten N® updates RSS · CI watch RSS
- Ache Laboratorios Farmaceuticos S.A. portfolio CI
Frequently asked questions about Baycuten N®
What is Baycuten N®?
How does Baycuten N® work?
What is Baycuten N® used for?
Who makes Baycuten N®?
Is Baycuten N® also known as anything else?
What drug class is Baycuten N® in?
What development phase is Baycuten N® in?
What are the side effects of Baycuten N®?
Related
- Drug class: All Topical corticosteroid with antimicrobial agent drugs
- Manufacturer: Ache Laboratorios Farmaceuticos S.A. — full pipeline
- Therapeutic area: All drugs in Dermatology
- Indication: Drugs for Inflammatory skin conditions with secondary bacterial infection or infection risk (e.g., eczema, dermatitis, impetigo)
- Also known as: clotrimazole and dexamethasone acetate
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing