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Desmopressin

Generic Name
Desmopressin
Brand Names
Ddavp, Nocdurna, Octostim
Drug Type
Small Molecule
Chemical Formula
C46H64N14O12S2
CAS Number
16679-58-6
Unique Ingredient Identifier
ENR1LLB0FP

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

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