Overview
Crisaborole is a novel oxaborole approved by FDA on December 14, 2016 as Eucrisa, a topical treatment of for mild to moderate atopic dermatitis. This non-steroidal agent is efficacious in improving disease severity, reducing the risk of infection and reducing the signs and symptoms in patients 2 years old and older. It reduces the local inflammation in the skin and prevents further exacerbation of the disease with a good safety profile. Its structure contains a boron atom, which facilitates skin penetration and binding to the bimetal center of the phosphodiesterase 4 enzyme. It is currently under development as topical treatment of psoriasis.
Indication
Intended for the topical treatment of mild to moderate atopic dermatitis in patients 2 years of age and older.
Associated Conditions
- Mild Atopic dermatitis
- Moderate Atopic dermatitis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/11/07 | Phase 2 | Recruiting | Sun Yat-sen University | ||
2022/03/28 | Phase 2 | Completed | |||
2022/01/20 | Phase 4 | Terminated | |||
2021/08/23 | Phase 3 | Withdrawn | |||
2021/03/16 | Early Phase 1 | Completed | |||
2020/08/04 | Phase 3 | Terminated | |||
2020/04/24 | Phase 3 | Completed | |||
2020/03/06 | Phase 2 | Withdrawn | |||
2020/01/02 | Phase 4 | UNKNOWN | |||
2019/12/11 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Pfizer Laboratories Div Pfizer Inc | 55724-211 | TOPICAL | 20 mg in 1 g | 4/10/2020 | |
| Pharmacia & Upjohn Company LLC | 0009-2211 | TOPICAL | 20 mg in 1 g | 6/21/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Staquis Ointment 2% w/w | SIN16613P | OINTMENT | 2% w/w | 9/27/2022 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Crisaborole Ointment | 国药准字H20244979 | 化学药品 | 软膏剂 | 9/26/2024 | |
| Crisaborole Ointment | 国药准字H20249090 | 化学药品 | 软膏剂 | 10/16/2024 | |
| Crisaborole Ointment | 国药准字H20249089 | 化学药品 | 软膏剂 | 10/16/2024 | |
| Crisaborole Ointment | 国药准字HJ20200022 | 化学药品 | 软膏剂 | 7/29/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| STAQUIS crisaborole 2% w/w ointment tube | 295283 | Medicine | A | 2/20/2019 |
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