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DBI-002 Gel
DBI-002 Gel is a Skin microbiome modulator Biologic drug developed by DermBiont, Inc.. It is currently in Phase 2 development for Moderate to severe atopic dermatitis.
DBI-002 Gel is a topical treatment that modulates the skin microbiome to improve symptoms of atopic dermatitis.
DBI-002 Gel is a topical treatment that modulates the skin microbiome to improve symptoms of atopic dermatitis. Used for Moderate to severe atopic dermatitis.
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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 | DBI-002 Gel |
|---|---|
| Sponsor | DermBiont, Inc. |
| Drug class | Skin microbiome modulator |
| Modality | Biologic |
| Therapeutic area | Dermatology |
| Phase | Phase 2 |
Mechanism of action
DBI-002 Gel works by altering the balance of the skin microbiome, reducing inflammation and improving the integrity of the skin barrier. This is achieved through the application of a specific formulation that selectively targets and modifies the skin microbiome, leading to improved symptoms of atopic dermatitis.
Approved indications
- Moderate to severe atopic dermatitis
Common side effects
- Skin irritation
Key clinical trials
- A Trial to Evaluate the Safety and Antimicrobial Efficacy of DBI-002 Probiotic in Adults With Tinea Versicolor (PHASE2)
- A Trial to Evaluate the Safety and Efficacy of DBI-001 Gel, DBI-002 Gel, and Aqueous Gel in Subjects With Onychomycosis (PHASE2)
- A Trial to Evaluate the Safety and Efficacy of DBI-001 Gel, DBI-002 Gel, and Aqueous Gel in Subjects With Tinea Pedis (PHASE2)
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:
- DBI-002 Gel CI brief — competitive landscape report
- DBI-002 Gel updates RSS · CI watch RSS
- DermBiont, Inc. portfolio CI
Frequently asked questions about DBI-002 Gel
What is DBI-002 Gel?
How does DBI-002 Gel work?
What is DBI-002 Gel used for?
Who makes DBI-002 Gel?
What drug class is DBI-002 Gel in?
What development phase is DBI-002 Gel in?
What are the side effects of DBI-002 Gel?
Related
- Drug class: All Skin microbiome modulator drugs
- Manufacturer: DermBiont, Inc. — full pipeline
- Therapeutic area: All drugs in Dermatology
- Indication: Drugs for Moderate to severe atopic dermatitis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing