Overview
Cyproheptadine is a potent competitive antagonist of both serotonin and histamine receptors. It is used primarily to treat allergic symptoms, though it is perhaps more notable for its use in appetite stimulation and its off-label use in the treatment of serotonin syndrome.
Background
Cyproheptadine is a potent competitive antagonist of both serotonin and histamine receptors. It is used primarily to treat allergic symptoms, though it is perhaps more notable for its use in appetite stimulation and its off-label use in the treatment of serotonin syndrome.
Indication
In the US, prescription cyproheptadine is indicated for the treatment of various allergic symptomatologies - including dermatographia, rhinitis, conjunctivitis, and urticaria - as well as adjunctive therapy in the management of anaphylaxis following treatment with epinephrine. In Canada, cyproheptadine is available over-the-counter and is indicated for the treatment of pruritus and for appetite stimulation. In Australia, cyproheptadine is additionally indicated for the treatment vascular headaches. Cyproheptadine is also used off-label for the treatment of serotonin syndrome.
Associated Conditions
- Allergic Reactions caused by Transfusions
- Anaphylaxis
- Angioedema and urticaria
- Cold urticaria
- Conjunctivitis allergic caused by Food Allergy
- Conjunctivitis allergic caused by inhalant allergens
- Perennial Allergic Rhinitis (PAR)
- Pruritus
- Seasonal Allergic Rhinitis
- Serotonin Syndrome
- Vasomotor Rhinitis
- Dermatographism
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/05 | Not Applicable | Completed | |||
2024/12/27 | Phase 4 | Recruiting | |||
2023/12/18 | Phase 2 | Active, not recruiting | Corey Hawes | ||
2022/07/21 | Phase 2 | Recruiting | |||
2021/07/28 | Phase 3 | UNKNOWN | |||
2021/05/06 | Phase 2 | UNKNOWN | Ciusss de L'Est de l'Île de Montréal | ||
2021/03/29 | Phase 3 | UNKNOWN | Ciusss de L'Est de l'Île de Montréal | ||
2020/07/27 | Phase 2 | Recruiting | |||
2019/09/27 | Phase 2 | Completed | |||
2018/07/20 | Early Phase 1 | Active, not recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Marlex Pharmaceuticals Inc | 10135-638 | ORAL | 4 mg in 1 1 | 11/3/2022 | |
| State of Florida DOH Central Pharmacy | 53808-0950 | ORAL | 4 mg in 1 1 | 5/21/2010 | |
| Bryant Ranch Prepack | 71335-1107 | ORAL | 4 mg in 1 1 | 4/12/2018 | |
| PD-Rx Pharmaceuticals, Inc. | 72789-102 | ORAL | 4 mg in 1 1 | 3/29/2024 | |
| Zydus Lifesciences Limited | 70771-1076 | ORAL | 4 mg in 1 1 | 8/4/2022 | |
| REMEDYREPACK INC. | 70518-2414 | ORAL | 4 mg in 1 1 | 2/29/2024 | |
| Rising Pharma Holdings, Inc. | 16571-805 | ORAL | 4 mg in 1 1 | 2/8/2022 | |
| Bryant Ranch Prepack | 72162-2066 | ORAL | 4 mg in 1 1 | 8/15/2023 | |
| Quality Care Products, LLC | 55700-700 | ORAL | 4 mg in 1 1 | 11/20/2018 | |
| Physicians Total Care, Inc. | 54868-1332 | ORAL | 4 mg in 1 1 | 1/11/2011 |
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 |
|---|---|---|---|---|---|
| PILIAN TABLET 4 mg | SIN06637P | TABLET | 4 mg | 10/22/1991 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Cyproheptadine Hydrochloride Cream | 国药准字H20066349 | 化学药品 | 乳膏剂 | 1/29/2021 | |
| Cyproheptadine Cream | 国药准字H32026058 | 化学药品 | 乳膏剂 | 7/22/2020 | |
| Cyproheptadine Hydrochloride Tablets | 国药准字H41022778 | 化学药品 | 片剂 | 6/19/2020 | |
| Cyproheptadine Hydrochloride Tablets | 国药准字H37022660 | 化学药品 | 片剂 | 3/12/2020 | |
| Cyproheptadine Hydrochloride Tablets | 国药准字H37022283 | 化学药品 | 片剂 | 7/23/2020 | |
| Cyproheptadine Hydrochloride Tablets | 国药准字H31020510 | 化学药品 | 片剂 | 11/1/2019 | |
| Cyproheptadine Hydrochloride Tablets | 国药准字H11021323 | 化学药品 | 片剂 | 12/23/2020 | |
| Cyproheptadine Hydrochloride Tablets | 国药准字H23022366 | 化学药品 | 片剂 | 6/19/2020 | |
| Cyproheptadine Hydrochloride Tablets | 国药准字H41023918 | 化学药品 | 片剂 | 7/6/2020 | |
| Cyproheptadine Hydrochloride Tablets | 国药准字H13022201 | 化学药品 | 片剂 | 1/15/2021 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| CYPROHEPTADINE TAB 4MG | N/A | N/A | N/A | 7/15/1982 | |
| MULTIMAX SYRUP | N/A | N/A | N/A | 7/8/2014 | |
| CYPRODIN TAB 4MG | N/A | N/A | N/A | 2/28/2000 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| PERIACTIN cyproheptadine hydrochloride (as sesquihydrate) 4mg tablet blister pack | 62384 | Medicine | A | 1/29/1998 |