Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication Pimecrolimus Cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. FDA label
Also known as Elidel
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 26 competitors
Pimecrolimus is used for the treatment of atopic dermatitis, a form of eczema. It is being developed as a cream formulation for patients with mild to moderate atopic dermatitis. Clinical trials have enrolled adults and children, including infants as young as 3 months of age.
Pimecrolimus targets FKBP1A and acts as an inhibitor. By binding to FKBP1A, it interferes with calcineurin-dependent signaling in T cells, which reduces the inflammatory response in the skin that drives atopic dermatitis. This makes it a non-steroidal option for topical treatment.
Pimecrolimus is being developed by Viatris Inc., which trades under the ticker VTRS. Viatris is the sponsor of the clinical development program for pimecrolimus cream, 1% in atopic dermatitis.
Pimecrolimus is in Phase 3 clinical development for atopic dermatitis. It is an investigational product and is not described as approved. Two Phase 3 trials have been completed, and no trials are currently listed as active.
Pimecrolimus has been studied in two completed Phase 3 trials. NCT03107611 was a bioequivalence study of pimecrolimus cream, 1% versus Elidel cream, 1% in mild to moderate atopic dermatitis, enrolling 654 patients. NCT00120523 was a 5-year safety study in infants aged 3 to 12 months, enrolling 2,418 patients.
Yes. Pimecrolimus is also known as pimecrolimus cream, 1%, and pimecrolimus, 1%. These names refer to the same topical product, a 1% cream formulation of the small molecule pimecrolimus that is being developed for atopic dermatitis.