Overview
Calcipotriol (INN) or calcipotriene (USAN) is a sythetic derivative of calcitriol or Vitamin D.
Background
Calcipotriol (INN) or calcipotriene (USAN) is a sythetic derivative of calcitriol or Vitamin D.
Indication
For the treatment of moderate plaque psoriasis in adults.
Associated Conditions
- Plaque psoriasis of the scalp
- Psoriasis Vulgaris (Plaque Psoriasis)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/03/17 | Early Phase 1 | ENROLLING_BY_INVITATION | Dr ayesha wahid | ||
2024/12/17 | Not Applicable | Not yet recruiting | |||
2024/11/12 | Not Applicable | Not yet recruiting | St Vincent's University Hospital, Ireland | ||
2024/03/25 | Phase 4 | Completed | Psoriasis Treatment Center of Central New Jersey | ||
2023/07/20 | Not Applicable | Completed | |||
2023/01/26 | Phase 2 | Recruiting | |||
2022/06/13 | Early Phase 1 | Withdrawn | |||
2022/02/22 | Phase 3 | UNKNOWN | |||
2022/01/11 | Phase 4 | Active, not recruiting | Aarhus University Hospital | ||
2022/01/03 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Akorn | 50383-732 | TOPICAL | 0.05 mg in 1 mL | 3/4/2022 | |
| Sincerus Florida, LLC | 72934-5034 | TOPICAL | 0.005 g in 100 g | 5/10/2019 | |
| Taro Pharmaceuticals U.S.A., Inc. | 51672-4154 | TOPICAL | 0.05 mg in 1 g | 12/3/2019 | |
| Bryant Ranch Prepack | 63629-2520 | TOPICAL | 50 ug in 1 g | 1/10/2022 | |
| Mayne Pharma | 51862-376 | TOPICAL | 50 ug in 1 g | 3/31/2023 | |
| Sincerus Florida, LLC | 72934-4029 | TOPICAL | 0.005 g in 100 g | 5/20/2019 | |
| Cosette Pharmaceuticals, Inc. | 0713-0318 | TOPICAL | 0.05 mg in 1 mL | 11/15/2022 | |
| Mayne Pharma | 51862-512 | TOPICAL | 50 ug in 1 g | 12/1/2020 | |
| Physicians Total Care, Inc. | 54868-6091 | TOPICAL | 50 ug in 1 g | 8/18/2010 | |
| Glenmark Pharmaceuticals Inc., USA | 68462-310 | TOPICAL | 50 ug in 1 g | 4/17/2020 |
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 |
|---|---|---|---|---|---|
| DAIVOBET OINTMENT | SIN12241P | OINTMENT | 50 mcg/g | 3/27/2003 | |
| Daivobet Gel 50mcg/g + 0.5mg/g | SIN14318P | GEL | 0.05 mg/g | 3/1/2013 | |
| DAIVONEX OINTMENT 50 mcg/g | SIN06587P | OINTMENT | 50 mcg/g | 9/26/1991 | |
| ENSTILAR® CUTANEOUS FOAM 50mcg/g + 0.5mg/g | SIN15892P | AEROSOL, FOAM | 52.2mcg/g | 2/27/2020 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Calcipotriol Scalp Solution | 国药准字H20244295 | 化学药品 | 搽剂 | 6/28/2024 | |
| Calcipotriol Scalp Solution | 国药准字HJ20150664 | 化学药品 | 搽剂 | 9/4/2020 | |
| Calcipotriol Ointment | 国药准字HJ20160069 | 化学药品 | 软膏剂 | 1/5/2021 | |
| Calcipotriol Ointment | 国药准字HC20170010 | 化学药品 | 软膏剂 | 4/6/2022 | |
| Calcipotriol Ointment | 国药准字H20244065 | 化学药品 | 软膏剂 | 6/18/2024 | |
| Calcipotriol Ointment | 国药准字HJ20160070 | 化学药品 | 软膏剂 | 1/5/2021 | |
| Calcipotriol Ointment | 国药准字HC20170009 | 化学药品 | 软膏剂 | 4/6/2022 | |
| Calcipotriol Ointment | 国药准字H20203505 | 化学药品 | 软膏剂 | 9/30/2020 | |
| Calcipotriol Ointment | 国药准字H20113541 | 化学药品 | 软膏剂 | 9/30/2021 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| BF-CALBETSONE OINTMENT | N/A | bright future pharmaceuticals factory o/b bright future pharmaceutical laboratories limited | N/A | N/A | 4/24/2025 |
| BF-CALCIPOTRIOL OINTMENT 0.005% W/W | N/A | N/A | N/A | 5/29/2025 |