Overview
Desmopressin (dDAVP), a synthetic analogue of 8-arginine vasopressin (ADH), is an antidiuretic peptide drug modified by deamination of 1-cysteine and substitution of 8-L-arginine by 8-D-arginine. ADH is an endogenous pituitary hormone that has a crucial role in the control of the water content in the body. Upon release from the stimulation of increased plasma osmolarity or decreased circulating blood volume, ADH mainly acts on the cells of the distal part of the nephron and the collecting tubules in the kidney . The hormone interacts with V1, V2 or V3 receptors with differing signal cascade systems. Desmopressin displays enhanced antidiuretic potency, fewer pressor effects due to V2-selective actions, and a prolonged half-life and duration of action compared to endogenous ADH . It has been employed clinically since 1972 and is available in various formulations including intranasal solution, intravenous solution, oral tablet and oral lyophilisate . Desmopressin is indicated for the treatment of polyuric conditions including primary nocturnal enuresis, nocturia, and diabetes insipidus. It was also newly approved for the treatment of mild classical hemophilia and von Willebrand's disease for minor surgeries. The active ingredient in most formulations is desmopressin acetate. Nocdurna, or desmopressin acetate, was approved by the FDA on June 21st, 2018 for the treatment of nocturia due to nocturnal polyuria in adults. It is available as a sublingual tablet.
Indication
1.治疗中枢性尿崩症,可减少尿量、提高尿渗透压、降低血浆渗透压; 2.用于尿崩症的诊断和鉴别诊断; 3.用于治疗夜间遗尿症(六岁或以上的患者); 4.部分类型(甲型血友病和Ⅰ型血管性假血友病)的血友病及其他出血性疾病。
Associated Conditions
- Bleeding
- Hypothalamic Injury-induced Obesity (HIO)
- Nocturia
- Nocturnal Polyuria
- Polydipsia
- Polyuria
- Primary Nocturnal Enuresis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/06/19 | N/A | Active, not recruiting | Furkan Adem Canbaz | ||
2025/01/13 | Not Applicable | Completed | |||
2025/01/13 | Not Applicable | Recruiting | |||
2024/10/10 | Phase 2 | Recruiting | |||
2024/10/02 | Phase 4 | ENROLLING_BY_INVITATION | |||
2024/03/29 | Phase 3 | Recruiting | |||
2024/02/29 | Not Applicable | Recruiting | |||
2024/02/13 | Phase 4 | Not yet recruiting | Chengdu University of Traditional Chinese Medicine | ||
2023/12/29 | Not Applicable | Active, not recruiting | |||
2023/08/31 | Phase 3 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Zydus Lifesciences Limited | 70771-1314 | NASAL | 0.1 mg in 1 mL | 10/31/2022 | |
Bryant Ranch Prepack | 72162-2129 | NASAL | 10 ug in 1 1 | 9/19/2023 | |
UBI Pharma Inc. | 72843-459 | SUBCUTANEOUS, INTRAVENOUS | 4 ug in 1 mL | 10/16/2023 | |
Apotex Corp. | 60505-0258 | ORAL | 0.2 mg in 1 1 | 3/31/2023 | |
Amring Pharmaceuticals Inc. | 69918-201 | ORAL | 0.2 mg in 1 1 | 8/10/2020 | |
UBI Pharma Inc. | 72843-440 | SUBCUTANEOUS, INTRAVENOUS | 40 ug in 10 mL | 9/30/2022 | |
Sagent Pharmaceuticals | 25021-461 | INTRAVENOUS, SUBCUTANEOUS | 40 ug in 10 mL | 8/14/2020 | |
BluePoint Laboratories | 68001-574 | ORAL | 0.1 mg in 1 1 | 8/4/2023 | |
REMEDYREPACK INC. | 70518-3148 | ORAL | 0.1 mg in 1 1 | 3/17/2023 | |
Sun Pharmaceutical Industries, Inc. | 62756-529 | INTRAVENOUS, SUBCUTANEOUS | 4 ug in 1 mL | 1/23/2020 |
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 |
---|---|---|---|---|---|
MINIRIN NASAL SPRAY 10 mcg/dose | SIN03760P | SPRAY | 0.1 mg/ml | 1/17/1990 | |
Presinex Nasal Spray 10mcg/dose | SIN13414P | SPRAY, METERED | 0.1mg/ml | 2/25/2008 | |
MINIRIN Oral Lyophilisate 60 mcg | SIN14260P | TABLET, ORALLY DISINTEGRATING | 60 mcg | 10/30/2012 | |
MINIRIN Oral Lyophilisate 120 mcg | SIN14261P | TABLET, ORALLY DISINTEGRATING | 120 mcg | 10/30/2012 | |
MINIRIN INJECTION 4 mcg/ml | SIN04482P | INJECTION | 4 mcg/ml | 5/24/1990 | |
NOCDURNA ORAL LYOPHILISATE 50MCG | SIN15462P | TABLET, ORALLY DISINTEGRATING | 50mcg | 4/3/2018 | |
NOCDURNA ORAL LYOPHILISATE 25MCG | SIN15461P | TABLET, ORALLY DISINTEGRATING | 25mcg | 4/3/2018 | |
MINIRIN TABLET 0.1 mg (Oval) | SIN11656P | TABLET | 0.1 mg | 8/31/2001 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Desmopressin Oral Solution | 国药准字H20253512 | 化学药品 | 口服溶液剂 | 3/4/2025 | |
Desmopressin Oral Solution | 国药准字H20233514 | 化学药品 | 口服溶液剂 | 7/10/2023 | |
Desmopressin Oral Solution | 国药准字H20234012 | 化学药品 | 口服溶液剂 | 8/1/2023 | |
Desmopressin Acetate For Injection | 国药准字H20234711 | 化学药品 | 注射剂 | 12/29/2023 | |
Desmopressin Acetate For Injection | 国药准字H20100057 | 化学药品 | 注射剂 | 3/4/2020 | |
Desmopressin Acetate For Injection | 国药准字H20065069 | 化学药品 | 注射剂 | 4/15/2021 | |
Desmopressin Acetate For Injection | 国药准字H20213125 | 化学药品 | 注射剂 | 2/10/2021 | |
Desmopressin Acetate For Injection | 国药准字H20064094 | 化学药品 | 注射剂 | 9/27/2020 | |
Desmopressin Acetate For Injection | 国药准字H20100058 | 化学药品 | 注射剂 | 3/30/2020 | |
Desmopressin Acetate For Injection | 国药准字H20064093 | 化学药品 | 注射剂 | 9/27/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
MINIS TABLETS 0.2MG | N/A | N/A | N/A | 6/6/2025 | |
MINIS TABLETS 0.1MG | N/A | N/A | N/A | 6/6/2025 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
ADIN desmopressin acetate 100 microgram tablet (NF) | 99864 | Medicine | A | 9/13/2004 | |
OCTOSTIM desmopressin acetate 15 micrograms/1mL injection | 46758 | Medicine | A | 2/15/1994 | |
ADIN MELT desmopressin 120 micrograms sublingual wafers blister pack | 121724 | Medicine | A | 6/28/2007 | |
ADIN MELT desmopressin 240 micrograms sublingual wafers blister pack | 121725 | Medicine | A | 6/28/2007 | |
MINIRIN desmopressin acetate 200 microgram tablet bottle | 93731 | Medicine | A | 4/2/2003 | |
MINIRIN desmopressin acetate 10 microgram/ actuation nasal spray | 59320 | Medicine | A | 4/21/1997 | |
MINIRIN MELT desmopressin 120 micrograms sublingual wafers blister pack | 121721 | Medicine | A | 6/28/2007 | |
NOCDURNA desmopressin 50 micrograms (as acetate) sublingual wafers blister pack | 264292 | Medicine | A | 12/2/2016 | |
ADIN MELT desmopressin 60 micrograms sublingual wafers blister pack | 121723 | Medicine | A | 6/28/2007 | |
MINIRIN MELT desmopressin 60 micrograms sublingual wafers blister pack | 121720 | Medicine | A | 6/28/2007 |
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