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 small molecule being developed for the treatment of atopic dermatitis (eczema) and psoriasis. It is applied as an ointment and has been studied in clinical trials for these dermatological conditions.
Mapracorat is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded under the ticker symbol BAYRY on the OTC market.
Mapracorat is in Phase 2 clinical development. It has completed Phase 2 trials for atopic dermatitis and a Phase 1 trial for psoriasis. It is not yet approved by regulatory authorities and remains investigational.
Mapracorat has been studied in several completed trials. NCT01359787 evaluated different concentrations of Mapracorat ointment over 4 weeks in atopic dermatitis. NCT01407510 and NCT01408511 were HPA axis studies in Japanese and general adults with atopic dermatitis. NCT03399526 was a Phase 1 psoriasis plaque test.
Mapracorat is a distinct investigational compound. No alternative names have been reported in the clinical trial records. It is being studied under its own name for dermatological indications.