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IDP-121 · 3 trials · 1 indication
Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count.
Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm. For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately.
Treatment success was defined as at least a 2-grade reduction from Baseline in EGSS score and an EGSS score equating to "Clear" or "Almost Clear". EGSS was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
Acne severity will be determined by the investigator/evaluator based on a global assessment of the inflammatory and non-inflammatory lesions of facial acne. Evaluations will be graded on a static scale ranging from 0 (clear) to 4 (severe).
| Arm | Type | Description |
|---|---|---|
| IDP-121 Lotion | EXPERIMENTAL | IDP-121 lotion (tretinoin 0.05 percent \[%\]) will be applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks. |
| IDP-121 Vehicle Lotion | PLACEBO_COMPARATOR | IDP-121 lotion vehicle will be applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| IDP 121 Lotion | DRUG | IDP-121 lotion will be applied as per the instructions provided by the investigational center staff. |
| IDP-121 Vehicle Lotion | DRUG | IDP-121 vehicle lotion will be applied as per the instructions provided by the investigational center staff. |
| IDP-121 Lotion | DRUG | IDP-121 lotion will be applied as per the instructions provided by the investigational center staff. |
Key Inclusion Criteria: * Male or female at least 9 years of age and older. * Written and verbal informed consent must be obtained. Participants less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if participant reaches age of ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sunshine Biopharma Incorporated | SBFM | 2 | PHASE3 | 1% Clascoterone |
| Sanofi SA Sponsored ADR | SNY | 3 | PHASE1 | Acne mRNA vaccine |
| Hoth Therapeutics, Inc. | HOTH | 1 | PHASE2 | HT-001 2%, HT-001 1%, HT-001 0.5% |
| Sagimet Biosciences Inc. Class A | SGMT | 1 | PHASE1 | TVB-3567 |
| Bausch Health Companies Inc. | BHC | 1 | - | clindamycin, adapalene and benzoyl peroxide |
IDP-121 is an investigational small molecule being developed for the treatment of acne vulgaris, a common skin condition. It is formulated as a lotion and is being studied in patients as young as 9 years old. The drug is currently in clinical development and has not been approved by regulatory authorities.
IDP-121 is being developed by Bausch Health Companies Inc., a company publicly traded under the ticker symbol BHC. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating acne vulgaris.
IDP-121 is in Phase 3 clinical development for the treatment of acne vulgaris. Two Phase 3 trials have been completed, each enrolling 820 participants, along with an earlier Phase 1 study. The drug remains investigational and is not yet approved for commercial use.
IDP-121 has completed three clinical trials. NCT02849860 was a Phase 1 study of absorption and pharmacokinetics in 20 subjects. NCT02932306 and NCT02965456 were Phase 3 efficacy and safety trials, each enrolling 820 patients with acne. All trials were conducted in the United States.
IDP-121 is not FDA approved. It is an investigational drug currently in clinical development for acne vulgaris. While Phase 3 trials have been completed, the drug has not received regulatory approval and remains under investigation for safety and efficacy.