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IDP 121 Lotion
IDP 121 Lotion is a Calcineurin inhibitor Small molecule drug developed by Bausch Health Americas, Inc.. It is currently in Phase 3 development for Atopic dermatitis, Other inflammatory skin conditions.
IDP 121 is a topical lotion formulation designed to treat inflammatory skin conditions by reducing inflammation and modulating immune response in the skin.
IDP 121 is a topical lotion formulation designed to treat inflammatory skin conditions by reducing inflammation and modulating immune response in the skin. Used for Atopic dermatitis, Other inflammatory skin conditions.
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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 121 Lotion |
|---|---|
| Sponsor | Bausch Health Americas, Inc. |
| Drug class | Calcineurin inhibitor |
| Target | Calcineurin |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 3 |
Mechanism of action
IDP 121 is a calcineurin inhibitor-based topical therapy that works by suppressing T-cell activation and reducing inflammatory cytokine production in the epidermis and dermis. The lotion formulation allows for non-systemic delivery to affected skin areas, minimizing systemic exposure while providing localized anti-inflammatory effects.
Approved indications
- Atopic dermatitis
- Other inflammatory skin conditions
Common side effects
- Application site reactions
- Pruritus
- Skin irritation
Key clinical trials
- Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris (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:
- IDP 121 Lotion CI brief — competitive landscape report
- IDP 121 Lotion updates RSS · CI watch RSS
- Bausch Health Americas, Inc. portfolio CI
Frequently asked questions about IDP 121 Lotion
What is IDP 121 Lotion?
How does IDP 121 Lotion work?
What is IDP 121 Lotion used for?
Who makes IDP 121 Lotion?
What drug class is IDP 121 Lotion in?
What development phase is IDP 121 Lotion in?
What are the side effects of IDP 121 Lotion?
What does IDP 121 Lotion target?
Related
- Drug class: All Calcineurin inhibitor drugs
- Target: All drugs targeting Calcineurin
- Manufacturer: Bausch Health Americas, Inc. — full pipeline
- Therapeutic area: All drugs in Dermatology
- Indication: Drugs for Atopic dermatitis
- Indication: Drugs for Other inflammatory skin conditions
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing