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IDP 121 Lotion

Bausch Health Americas, Inc. · Phase 3 active Small molecule

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.

Likelihood of approval
58.3% vs 58.3% industry baseline
If approved by FDA: likely 2028–2030
Steps remaining: NDA/BLA submission
Confidence: High
Why this estimate
  • 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).
Predicted approval windows by jurisdiction (conditional on FDA approval)
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 nameIDP 121 Lotion
SponsorBausch Health Americas, Inc.
Drug classCalcineurin inhibitor
TargetCalcineurin
ModalitySmall molecule
Therapeutic areaDermatology
PhasePhase 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

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about IDP 121 Lotion

What is IDP 121 Lotion?

IDP 121 Lotion is a Calcineurin inhibitor drug developed by Bausch Health Americas, Inc., indicated for Atopic dermatitis, Other inflammatory skin conditions.

How does IDP 121 Lotion work?

IDP 121 is a topical lotion formulation designed to treat inflammatory skin conditions by reducing inflammation and modulating immune response in the skin.

What is IDP 121 Lotion used for?

IDP 121 Lotion is indicated for Atopic dermatitis, Other inflammatory skin conditions.

Who makes IDP 121 Lotion?

IDP 121 Lotion is developed by Bausch Health Americas, Inc. (see full Bausch Health Americas, Inc. pipeline at /company/bausch-health-americas-inc).

What drug class is IDP 121 Lotion in?

IDP 121 Lotion belongs to the Calcineurin inhibitor class. See all Calcineurin inhibitor drugs at /class/calcineurin-inhibitor.

What development phase is IDP 121 Lotion in?

IDP 121 Lotion is in Phase 3.

What are the side effects of IDP 121 Lotion?

Common side effects of IDP 121 Lotion include Application site reactions, Pruritus, Skin irritation.

What does IDP 121 Lotion target?

IDP 121 Lotion targets Calcineurin and is a Calcineurin inhibitor.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing