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
Research Report
A Comprehensive Monograph on Desmopressin (dDAVP): Pharmacology, Clinical Applications, and Risk Management
I. Executive Summary
Desmopressin is a synthetic analogue of the neurohypophyseal hormone arginine vasopressin (AVP), meticulously engineered to enhance its therapeutic utility while minimizing undesirable effects. Through two key structural modifications—deamination of the N-terminal cysteine and stereochemical inversion of the arginine at position 8—desmopressin exhibits potent and selective agonism at the vasopressin V2 receptor with a significantly prolonged duration of action compared to its endogenous counterpart.[1] This refined pharmacological profile underpins its dual therapeutic roles. As a powerful antidiuretic, it is a cornerstone therapy for conditions of excessive water loss, including central diabetes insipidus, primary nocturnal enuresis in children, and, more recently, nocturia due to nocturnal polyuria in adults.[2] Concurrently, its ability to stimulate the release of von Willebrand Factor and Factor VIII from endothelial cells establishes it as an important hemostatic agent for managing bleeding in patients with mild hemophilia A and Type I von Willebrand disease.[2]
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 | N/A | Completed | Groupe Maladies hémorragiques de Bretagne |
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 |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
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 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
DDAVP TABLETS 0.2MG | Ferring Inc | 00824143 | Tablet - Oral | 0.2 MG | 12/31/1995 |
MINIRIN | Ferring Inc | 02246500 | Tablet - Oral | 0.1 MG | 1/15/2003 |
DDAVP INJ 4MCG/ML | Ferring Inc | 00873993 | Liquid - Intramuscular
,
Subcutaneous
,
Intravenous | 4 MCG / ML | 12/31/1993 |
DESMOPRESSIN SPRAY | aa pharma inc | 02242465 | Spray, Metered Dose - Nasal | 10 MCG / ACT | 8/18/2000 |
DESMOPRESSIN TABLETS | rainbow pharmaceuticals inc | 02257718 | Tablet - Oral | 0.2 MG | 2/18/2005 |
APO-DESMOPRESSIN | 02284049 | Tablet - Oral | 0.2 MG | 1/31/2007 | |
OCTOSTIM LIQ INJ. 15MCG/ML | Ferring Inc | 02024179 | Solution - Subcutaneous
,
Intravenous | 15 MCG / ML | 12/31/1995 |
APO-DESMOPRESSIN | 02284030 | Tablet - Oral | 0.1 MG | 1/31/2007 | |
TEVA-DESMOPRESSIN | teva canada limited | 02287730 | Tablet - Oral | 0.1 MG | 7/16/2007 |
DDAVP RHINYLE | Ferring Inc | 00402516 | Solution - Nasal | 0.1 MG / ML | 12/31/1992 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
WETIRIN 0,2 mg COMPRIMIDOS | Ferring S.A. | 65910 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
WETIRIN 0,1 mg COMPRIMIDOS | Ferring S.A. | 65911 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
MINURIN 0, 1 MILIGRAMOS/MILILITRO GOTAS NASALES EN SOLUCION | Ferring S.A. | 55637 | GOTAS NASALES EN SOLUCIÓN | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Not Commercialized |
OCTOSTIM 1,5 mg/ml SOLUCIÓN PARA PULVERIZACIÓN NASAL | Ferring S.A. | 62821 | SOLUCION PARA PULVERIZACION NASAL | Diagnóstico Hospitalario | Commercialized |
DESMOPRESINA TEVA 0,2 mg COMPRIMIDOS EFG | Teva Pharma S.L.U. | 71385 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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