Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pimecrolimus · 2 trials · 1 indication
crude incidence of adverse events of primary interest and most frequent adverse events (greater than or equal to 5% crude incidence in either treatment group) in the treatment period
number (%) of patients with positive antibody titers to tetanus, hepatitis B, and measles vaccines at baseline, weeks 26 (6 months), 52 (1 year), 104 (2 years), 156 (3 years), 208 (4 years) and 260 (5 years) Varicella antibody titers were measured at the above time points in US patients only.
Investigator's Global Assessment of Disease Severity Scale: Clear (0) Minor residual discoloration, no erythema or induration/papulation, no oozing/crusting; Almost Clear (1) Trace faint pink erythema with almost no induration/papulation and no oozing/crusting; Mild disease (1) Faint pink erythema with mild induration/papulation and no oozing/crusting; Moderate disease (3) Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting; Severe disease (4) Deep/bright red erythema with severe induration/papulation with oozing/crusting
Investigator's Global Assessment of Disease Severity Scale: Clear (0) Minor residual discoloration, no erythema or induration/papulation, no oozing/crusting; Almost Clear (1) Trace faint pink erythema with almost no induration/papulation and no oozing/crusting; Mild disease (1) Faint pink erythema with mild induration/papulation and no oozing/crusting; Moderate disease (3) Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting; Severe disease (4) Deep/bright red erythema with severe induration/papulation with oozing/crusting
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Pimecrolimus |
| 2 | ACTIVE_COMPARATOR | Topical corticosteroids |
| Test | EXPERIMENTAL | Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days |
| Reference Standard | ACTIVE_COMPARATOR | Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days |
| Placebo | PLACEBO_COMPARATOR | Placebo cream, topical, thin layer applied to all affected skin areas twice daily for 14 days |
| Name | Type | Description |
|---|---|---|
| Pimecrolimus | DRUG | Pimecrolimus cream 1 % |
| Topical corticosteroids | DRUG | TCS |
| Pimecrolimus Cream, 1% | DRUG | - |
| Placebo Cream | DRUG | - |
Inclusion Criteria: * Aged 3 to \< 12 months * Diagnosis of AD fulfilling the diagnostic criteria of Seymour * AD affecting at least 5% total body surface area * Investigator's Global Assessment (IGA) score of 2 or 3, corresponding to mild-to-moderate disease at baseline * Informed consent Exclusi...
Top 20 of 25 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 9 | PHASE3 | Upadacitinib, corticosteroids |
| Pfizer Inc. | PFE | 11 | PHASE3 | Abrocitinib |
| Eli Lilly and Company | LLY | 4 | PHASE3 | Lebrikizumab, Corticosteroid |
| Sanofi SA Sponsored ADR | SNY | 13 | PHASE3 | Amlitelimab |
| Regeneron Pharmaceuticals, Inc. | REGN | 4 | PHASE3 | Dupilumab |
| Incyte Corporation | INCY | 3 | PHASE3 | Ruxolitinib, Vehicle |
| Organon & Co. | OGN | 1 | PHASE3 | Tapinarof, 1%, Vehicle |
| Apogee Therapeutics, Inc. | APGE | 3 | PHASE2 | APG777 |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE2 | GIA632 |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-95597528 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE2 | KT-621 |
| Corvus Pharmaceuticals, Inc. | CRVS | 1 | PHASE2 | Soquelitinib |
| Nektar Therapeutics | NKTR | 1 | PHASE2 | Rezpegaldesleukin |
| Celldex Therapeutics, Inc. | CLDX | 1 | PHASE2 | Barzolvolimab |
| Evommune, Inc. | EVMN | 1 | PHASE2 | EVO756 |
| Sunshine Biopharma Incorporated | SBFM | 3 | PHASE3 | 611, corticosteroid |
| Aclaris Therapeutics, Inc. | ACRS | 1 | PHASE2 | ATI-045 |
| Q32 Bio Inc | QTTB | 1 | PHASE2 | ADX-914 |
| Turn Therapeutics Inc. | TTRX | 1 | PHASE2 | GX-03 |
| Arcutis Biotherapeutics Inc | ARQT | 1 | PHASE1 | ARQ-234 |
Pimecrolimus is a small molecule used for atopic dermatitis, a form of eczema. It is being developed by Viatris Inc. (VTRS) and is currently in Phase 3 clinical development. The drug is being studied for the treatment of mild to moderate atopic dermatitis in patients as young as 3 months of age.
Pimecrolimus is a topical calcineurin inhibitor. It works by inhibiting the enzyme calcineurin, which plays a role in the activation of T-cells and the inflammatory response. This mechanism helps to reduce the inflammation and itching associated with atopic dermatitis.
Pimecrolimus is being developed by Viatris Inc., a global healthcare company traded on the NASDAQ under the ticker VTRS. The company is conducting Phase 3 clinical trials to evaluate the drug's safety and efficacy in treating atopic dermatitis.
Pimecrolimus is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. Two Phase 3 trials have been completed, with a total of 3,072 participants enrolled across studies in the United States, Germany, Dominican Republic, and Honduras.
Pimecrolimus has two completed Phase 3 trials. NCT00120523 is a 5-year safety study in infants aged 3 to 12 months with mild to moderate atopic dermatitis, enrolling 2,418 participants. NCT03107611 is a bioequivalence study comparing Pimecrolimus cream 1% to Elidel cream 1% in patients aged 8 years and older, enrolling 654 participants.
Pimecrolimus is the active ingredient in Elidel cream. The bioequivalence study NCT03107611 compared Pimecrolimus cream 1% to Elidel cream 1% to determine if the generic version is equivalent to the brand-name product. Both contain the same active ingredient at the same concentration.