Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Mapracorat · 4 trials · 3 indications
Assessment was done on the test fields on psoriatic plaques
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Mapracorat 0.01% Ointment | ACTIVE_COMPARATOR | Lowest concentration |
| Mapracorat 0.03% Ointment | ACTIVE_COMPARATOR | Middle concentration |
| Mapracorat 0.1% Ointment | ACTIVE_COMPARATOR | Highest concentration |
| Vehicle without active | PLACEBO_COMPARATOR | - |
| Mapracorat | EXPERIMENTAL | 10 µL of mapracorat was applied on 6 days a week for up to 4 weeks onto the corresponding test fields (3 cm2) of the affected skin plaques (15 cm2 were treated in total \[diameter 2 cm, distance to next test field at least 2 cm\]). 200 µL of mapracorat was applied on 6 days a week for up to 4 weeks onto the defined test fields (12.5 cm2 were treated in total \[diameter 1.8 cm, distance to next test field at least 1.5 cm\]) occluded with Finn chambers of the non-lesional skin areas of 2.5 cm2 |
| Prednicarbate | ACTIVE_COMPARATOR | 10 µL of prednicarbate was applied on 6 days a week for up to 4 weeks onto the corresponding test fields (3 cm2) of the affected skin plaques (15 cm2 were treated in total \[diameter 2 cm, distance to next test field at least 2 cm\]). 200 µL of prednicarbate was applied on 6 days a week for up to 4 weeks onto the defined test fields (12.5 cm2 were treated in total \[diameter 1.8 cm, distance to next test field at least 1.5 cm\]) occluded with Finn chambers of the non-lesional skin areas of 2.5 cm2 |
| Clobetasol | ACTIVE_COMPARATOR | 10 µL of clobetasol was applied on 6 days a week for up to 4 weeks onto the corresponding test fields (3 cm2) of the affected skin plaques (15 cm2 were treated in total \[diameter 2 cm, distance to next test field at least 2 cm\]). 200 µL of clobetasol was applied on 6 days a week for up to 4 weeks onto the defined test fields (12.5 cm2 were treated in total \[diameter 1.8 cm, distance to next test field at least 1.5 cm\]) occluded with Finn chambers of the non-lesional skin areas of 2.5 cm2 |
| Calcipotriene | ACTIVE_COMPARATOR | 10 µL of calcipotriene was applied on 6 days a week for up to 4 weeks onto the corresponding test fields (3 cm2) of the affected skin plaques (15 cm2 were treated in total \[diameter 2 cm, distance to next test field at least 2 cm\]). 200 µL of calcipotriene was applied on 6 days a week for up to 4 weeks onto the defined test fields (12.5 cm2 were treated in total \[diameter 1.8 cm, distance to next test field at least 1.5 cm\]) occluded with Finn chambers of the non-lesional skin areas of 2.5 cm2 |
| Calcipotriene/Betamethasone dipropionate | ACTIVE_COMPARATOR | 10 µL of calcipotriene/betamethasone dipropionate was applied on 6 days a week for up to 4 weeks onto the corresponding test fields (3 cm2) of the affected skin plaques (15 cm2 were treated in total \[diameter 2 cm, distance to next test field at least 2 cm\]). 200 µL of calcipotriene/betamethasone dipropionate was applied on 6 days a week for up to 4 weeks onto the defined test fields (12.5 cm2 were treated in total \[diameter 1.8 cm, distance to next test field at least 1.5 cm\]) occluded with Finn chambers of the non-lesional skin areas of 2.5 cm2 |
| Name | Type | Description |
|---|---|---|
| Mapracorat | DRUG | Application of the investigational product on the affected skin areas |
| Vehicle without active | DRUG | Daily topical application |
| Mapracorat (ZK 245186, BAY 86-5319) | DRUG | 0.1% (1 mg/g) of the active ingredient mapracorat plus excipients as ointment |
| Prednicarbate 0.25% ointment | DRUG | 0.25% (2.5 mg/g) of the active ingredient prednicarbate as ointment |
| Clobetasol 0.05% ointment | DRUG | 0.05% (0.5 mg/g) of the active ingredient clobetasol as ointment |
| Calcipotriene 0.005% ointment | DRUG | 0.005% (0.05 mg/g) of the active ingredient calcipotriene as ointment |
| Calcipotriene 0.005%/Betamethasone dipropionate 0.05% ointment | DRUG | 0.005% (0.05 mg/g) of the active ingredient calcipotriene/0.05% (0.5 mg/g) of the active ingredient betamethasone dipropionate as ointment |
Inclusion Criteria: * Signed written informed consent * Male or female subject aged \>= 18 years * Diagnosis of atopic dermatitis according to Hanifin and Rajka Criteria * Investigator's Global Assessment (IGA) score of 3 (moderate) to 4 (severe) at baseline * Normal ACTH response before start of t...
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Mapracorat is an investigational topical small molecule developed for inflammatory skin conditions, specifically atopic dermatitis and psoriasis. It has been studied as an ointment applied to affected skin in adults with atopic dermatitis and in plaque psoriasis. It is not approved for any indication and remains in clinical development.
Mapracorat targets NR3C1, the glucocorticoid receptor, and acts as an agonist at that receptor. This receptor mediates the anti-inflammatory effects associated with corticosteroid drugs. By binding and activating NR3C1, mapracorat is designed to reduce skin inflammation in atopic dermatitis and psoriasis.
Mapracorat is developed by Bayer AG, which trades over the counter in the United States under the ticker BAYRY. Bayer sponsored the clinical studies of the compound in dermatology indications, including the atopic dermatitis and psoriasis trials conducted in Germany, South Africa, and Japan.
Mapracorat is in Phase 2 clinical development. It is investigational and has not been approved by the FDA or any other regulatory agency for atopic dermatitis, psoriasis, or any other indication. All reported trials of the drug have been completed, and no active trials are currently listed.
Completed studies include NCT01359787, a Phase 2 trial of different mapracorat ointment concentrations over four weeks in atopic dermatitis with 197 patients, plus two Phase 2 HPA axis studies, NCT01408511 in South Africa and NCT01407510 in Japan. A Phase 1 psoriasis plaque test, NCT03399526, was also completed in Germany.
Yes. Mapracorat is also known as ZK 245186 and BAY 86-5319, which are earlier and alternate identifiers for the same Bayer compound. Searches using any of these three names refer to the same investigational topical glucocorticoid receptor agonist studied in atopic dermatitis and psoriasis.