Overview
Apremilast, also known as Otezla, is a phosphodiesterase 4 (PDE4) inhibitor used to treat various types of symptoms resulting from certain inflammatory autoimmune diseases. It belongs to the same drug class as Roflumilast and Crisaborole. Initially approved in 2014, it is marketed by Celgene. In July 2019, apremilast was granted a new FDA approval for the treatment of oral ulcers associated with Behcet's disease, an autoimmune condition that causes recurrent skin, blood vessel, and central nervous system inflammation.
Background
Apremilast, also known as Otezla, is a phosphodiesterase 4 (PDE4) inhibitor used to treat various types of symptoms resulting from certain inflammatory autoimmune diseases. It belongs to the same drug class as Roflumilast and Crisaborole. Initially approved in 2014, it is marketed by Celgene. In July 2019, apremilast was granted a new FDA approval for the treatment of oral ulcers associated with Behcet's disease, an autoimmune condition that causes recurrent skin, blood vessel, and central nervous system inflammation.
Indication
Apremilast is indicated for the treatment of adults with active psoriatic arthritis and adults with oral ulcers associated with Behcet's Disease. In addition, apremilast is indicated for the treatment of plaque psoriasis, of any severity, in adult patients who are candidates for phototherapy or systemic therapy.
Associated Conditions
- Psoriasis Vulgaris (Plaque Psoriasis)
- Active Psoriatic arthritis
- Ulceration of the mouth
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2019/04/29 | Phase 3 | Completed | |||
2019/02/11 | Phase 2 | Withdrawn | |||
2019/02/04 | N/A | Completed | |||
2018/12/20 | Phase 4 | Completed | |||
2018/12/17 | Phase 3 | Completed | |||
2018/12/13 | Phase 4 | Completed | |||
2018/11/28 | N/A | Completed | |||
2018/11/20 | Phase 4 | Completed | |||
2018/11/15 | Phase 4 | Withdrawn | |||
2018/11/14 | N/A | NO_LONGER_AVAILABLE |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Apremilast Tablets | 国药准字H20234657 | 化学药品 | 片剂 | 12/19/2023 | |
| Apremilast Tablets | 国药准字H20243529 | 化学药品 | 片剂 | 4/17/2024 | |
| Apremilast Tablets | 国药准字H20243680 | 化学药品 | 片剂 | 5/15/2024 | |
| Apremilast Tablets | 国药准字H20243528 | 化学药品 | 片剂 | 4/17/2024 | |
| Apremilast Tablets | 国药准字H20233379 | 化学药品 | 片剂 | 3/24/2023 | |
| Apremilast Tablets | 国药准字H20233378 | 化学药品 | 片剂 | 3/24/2023 | |
| Apremilast Tablets | 国药准字H20233380 | 化学药品 | 片剂 | 3/24/2023 | |
| Apremilast Tablets | 国药准字H20234153 | 化学药品 | 片剂 | 9/12/2023 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||