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IDP-126 Gel
IDP-126 Gel is a Retinoid Small molecule drug developed by Bausch Health Americas, Inc.. It is currently in Phase 3 development for Plaque psoriasis, Atopic dermatitis. Also known as: IDP-126.
IDP-126 is a topical retinoid that modulates retinoid receptor signaling to reduce inflammation and promote skin cell differentiation in dermatological conditions.
IDP-126 Gel is a small molecule being studied as a potential treatment for Acne Vulgaris. It is being compared to control gel, clindamycin phosphate, adapalene, and benzoyl peroxide in clinical trials.
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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 | IDP-126 Gel |
|---|---|
| Also known as | IDP-126 |
| Sponsor | Bausch Health Americas, Inc. |
| Drug class | Retinoid |
| Target | Retinoid receptors (RAR/RXR) |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 3 |
Mechanism of action
IDP-126 Gel is a novel retinoid compound formulated for topical application. It works by binding to retinoid receptors in the skin, which helps normalize keratinocyte differentiation, reduce inflammatory cytokine production, and improve skin barrier function. This mechanism makes it suitable for treating inflammatory skin disorders.
Approved indications
- Plaque psoriasis
- Atopic dermatitis
Common side effects
- Application site irritation
- Erythema
- Scaling
- Pruritus
Key clinical trials
- Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Triple Combination Gel in Canadian Patients With Acne Vulgaris
- Study to Compare the Safety and Efficacy of IDP-126 Gel to Epiduo® Forte Gel and Vehicle Gel (PHASE2)
- Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris (PHASE3)
- Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris (PHASE3)
- A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris (PHASE2)
- Open-Label, Randomized Study Evaluating the Absorption and Systemic Pharmacokinetics of Topically Applied IDP-126 Gel in Comparison With Control Gel (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:
- IDP-126 Gel CI brief — competitive landscape report
- IDP-126 Gel updates RSS · CI watch RSS
- Bausch Health Americas, Inc. portfolio CI
Frequently asked questions about IDP-126 Gel
What is IDP-126 Gel?
How does IDP-126 Gel work?
What is IDP-126 Gel used for?
Who makes IDP-126 Gel?
Is IDP-126 Gel also known as anything else?
What drug class is IDP-126 Gel in?
What development phase is IDP-126 Gel in?
What are the side effects of IDP-126 Gel?
What does IDP-126 Gel target?
Related
- Drug class: All Retinoid drugs
- Target: All drugs targeting Retinoid receptors (RAR/RXR)
- Manufacturer: Bausch Health Americas, Inc. — full pipeline
- Therapeutic area: All drugs in Dermatology
- Indication: Drugs for Plaque psoriasis
- Indication: Drugs for Atopic dermatitis
- Also known as: IDP-126
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing