desmopressin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
vasopressin analogues	817	16679-58-6

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: desmopressin acetate hydrate minirinmelt desmopressin adiuretin minirin desmopressin acetate DDAVP	A synthetic analog of the pituitary hormone, ARGININE VASOPRESSIN. Its action is mediated by the VASOPRESSIN receptor V2. It has prolonged antidiuretic activity, but little pressor effects. It also modulates levels of circulating FACTOR VIII and VON WILLEBRAND FACTOR. Molecular weight: 1069.22 Formula: C46H64N14O12S2 CLOGP: -2.31 LIPINSKI: 3 HAC: 26 HDO: 14 TPSA: 435.41 ALOGS: -3.99 ROTB: 19 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

desmopressin acetate hydrate
minirinmelt
desmopressin
adiuretin
minirin
desmopressin acetate
DDAVP

A synthetic analog of the pituitary hormone, ARGININE VASOPRESSIN. Its action is mediated by the VASOPRESSIN receptor V2. It has prolonged antidiuretic activity, but little pressor effects. It also modulates levels of circulating FACTOR VIII and VON WILLEBRAND FACTOR.

Molecular weight: 1069.22
Formula: C46H64N14O12S2
CLOGP: -2.31
LIPINSKI: 3
HAC: 26
HDO: 14
TPSA: 435.41
ALOGS: -3.99
ROTB: 19

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
25	mcg	N
0.40	mg	O
4	mcg	P
0.24	mg	SL

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	47 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.00 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	15 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	0.30 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	1.40 mL/min/kg	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	3 hours	Lombardo F, Berellini G, Obach RS
S (Water solubility)	0.10 mg/mL	Bocci G, Oprea TI, Benet LZ

Approvals:

Date	Agency	Company	Orphan
Feb. 21, 1978	FDA	FERRING PHARMS INC
June 18, 2019	PMDA	FERRING PHARMACEUTICALS CO., LTD.

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Hyponatraemia	576.62	18.04	252	5417	111648	63371705
Hyponatraemic encephalopathy	178.32	18.04	29	5640	227	63483126
Hyponatraemic seizure	110.84	18.04	21	5648	422	63482931
Craniopharyngioma	110.77	18.04	18	5651	140	63483213
Recalled product administered	107.29	18.04	21	5648	504	63482849
Hypernatraemia	84.39	18.04	30	5639	7579	63475774
Seizure	81.26	18.04	78	5591	132556	63350797
Water intoxication	80.69	18.04	16	5653	411	63482942
Poor quality product administered	69.85	18.04	21	5648	3135	63480218
Diabetes insipidus	69.20	18.04	20	5649	2605	63480748
Blood sodium decreased	61.88	18.04	34	5635	24218	63459135
Renal salt-wasting syndrome	59.73	18.04	12	5657	330	63483023
Pharyngeal haemorrhage	59.08	18.04	13	5656	559	63482794
Adrenocortical insufficiency acute	54.09	18.04	15	5654	1683	63481670
Tonsillar disorder	50.02	18.04	13	5656	1140	63482213
Brain injury	49.85	18.04	20	5649	7023	63476330
Patent ductus arteriosus	48.04	18.04	17	5652	4233	63479120
Electrolyte imbalance	45.38	18.04	26	5643	20050	63463303
Osmotic demyelination syndrome	41.36	18.04	10	5659	653	63482700
Product prescribing error	41.35	18.04	27	5642	26262	63457091
Oesophageal disorder	36.66	18.04	12	5657	2361	63480992
Brain oedema	36.47	18.04	20	5649	14175	63469178
Premature baby	34.34	18.04	22	5647	20713	63462640
Blood sodium increased	31.15	18.04	11	5658	2721	63480632
Labelled drug-disease interaction medication error	30.65	18.04	6	5663	144	63483209
Insulin-like growth factor decreased	30.06	18.04	7	5662	389	63482964
Hepatitis toxic	29.28	18.04	11	5658	3242	63480111
Hypoosmolar state	29.17	18.04	6	5663	186	63483167
Oligohydramnios	28.27	18.04	13	5656	6353	63477000
Polyuria	27.52	18.04	14	5655	8528	63474825
Hypopituitarism	26.97	18.04	8	5661	1140	63482213
Exposure during pregnancy	26.77	18.04	49	5620	155498	63327855
Gastrointestinal infection	26.42	18.04	14	5655	9267	63474086
Thoracotomy	25.66	18.04	4	5665	23	63483330
Abortion induced	25.13	18.04	14	5655	10228	63473125
Headache	24.95	18.04	117	5552	633124	62850229
Neoplasm recurrence	24.03	18.04	9	5660	2629	63480724
Foetal exposure during pregnancy	23.80	18.04	21	5648	31941	63451412
Cutaneous lupus erythematosus	23.79	18.04	9	5660	2703	63480650
Generalised tonic-clonic seizure	23.49	18.04	20	5649	28996	63454357
Encephalopathy	22.25	18.04	22	5647	38598	63444755
Germ cell cancer	21.80	18.04	4	5665	67	63483286
Blood sodium abnormal	21.31	18.04	6	5663	711	63482642
Urine output decreased	21.18	18.04	13	5656	11357	63471996
Hypothalamo-pituitary disorder	21.02	18.04	6	5663	747	63482606
Urine sodium increased	20.24	18.04	4	5665	101	63483252
Insulin-like growth factor increased	19.84	18.04	6	5663	913	63482440
Disseminated intravascular coagulation	19.37	18.04	15	5654	19036	63464317
Pituitary tumour benign	18.88	18.04	7	5662	1988	63481365
Hypoglycaemia	18.88	18.04	25	5644	60040	63423313
Thirst	18.67	18.04	13	5656	14028	63469325
Epilepsy	18.60	18.04	17	5652	27048	63456305

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Hyponatraemia	406.83	16.89	219	5533	82472	34868707
Craniopharyngioma	149.75	16.89	28	5724	271	34950908
Water intoxication	93.08	16.89	20	5732	408	34950771
Chorioretinopathy	72.70	16.89	21	5731	1472	34949707
Diabetes insipidus	70.33	16.89	24	5728	2904	34948275
Osmotic demyelination syndrome	69.50	16.89	18	5734	837	34950342
Head titubation	66.11	16.89	15	5737	396	34950783
Hypernatraemia	60.42	16.89	29	5723	8461	34942718
Hyponatraemic encephalopathy	58.74	16.89	10	5742	53	34951126
Labelled drug-disease interaction medication error	51.43	16.89	10	5742	121	34951058
Seizure	49.82	16.89	73	5679	104784	34846395
Cogwheel rigidity	48.41	16.89	15	5737	1337	34949842
Germ cell cancer	40.61	16.89	8	5744	104	34951075
Apnoeic attack	39.68	16.89	10	5742	416	34950763
Extrapyramidal disorder	38.86	16.89	25	5727	12855	34938324
Renal salt-wasting syndrome	36.66	16.89	9	5743	336	34950843
Sedation complication	36.64	16.89	13	5739	1764	34949415
Inappropriate antidiuretic hormone secretion	36.63	16.89	24	5728	12729	34938450
Neoplasm recurrence	33.65	16.89	13	5739	2236	34948943
Hypopituitarism	33.47	16.89	13	5739	2269	34948910
Serotonin syndrome	33.25	16.89	27	5725	19906	34931273
Polyuria	31.84	16.89	19	5733	8555	34942624
Duplicate therapy error	31.25	16.89	7	5745	174	34951005
Epiphysiolysis	29.01	16.89	6	5746	101	34951078
Reaction to excipient	28.47	16.89	8	5744	507	34950672
Insulin-like growth factor decreased	28.39	16.89	7	5745	266	34950913
Recalled product administered	28.08	16.89	8	5744	533	34950646
Hyperadrenocorticism	27.89	16.89	6	5746	123	34951056
Rebound effect	25.79	16.89	12	5740	3262	34947917
Pharyngeal haemorrhage	25.33	16.89	8	5744	759	34950420
Blood sodium increased	24.19	16.89	11	5741	2837	34948342
Urinary tract infection	23.19	16.89	46	5706	84035	34867144
Urine osmolarity increased	22.18	16.89	5	5747	128	34951051
Flushing	22.16	16.89	27	5725	32393	34918786
Insulin-like growth factor increased	21.54	16.89	8	5744	1235	34949944
Pollakiuria	21.53	16.89	21	5731	19653	34931526
Anticholinergic syndrome	21.38	16.89	8	5744	1261	34949918
Compulsive shopping	21.09	16.89	6	5746	398	34950781
Implant site pruritus	21.06	16.89	3	5749	3	34951176
CNS germinoma	21.06	16.89	3	5749	3	34951176
Polydipsia	20.87	16.89	11	5741	3904	34947275
Toxic neuropathy	19.16	16.89	6	5746	553	34950626
Urinary retention	18.26	16.89	26	5726	36262	34914917
Akathisia	17.94	16.89	13	5739	8096	34943083
Therapeutic response decreased	17.78	16.89	23	5729	29290	34921889
Hyperthermia malignant	17.21	16.89	8	5744	2169	34949010
Muscle rigidity	17.01	16.89	14	5738	10504	34940675
Product use in unapproved indication	16.92	16.89	50	5702	117449	34833730

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Hyponatraemia	891.95	15.02	432	9268	177416	79557272
Hyponatraemic encephalopathy	214.58	15.02	37	9663	303	79734385
Craniopharyngioma	195.35	15.02	35	9665	365	79734323
Water intoxication	148.85	15.02	31	9669	743	79733945
Hypernatraemia	132.84	15.02	54	9646	14397	79720291
Diabetes insipidus	126.31	15.02	40	9660	5197	79729491
Seizure	125.94	15.02	134	9566	188700	79545988
Osmotic demyelination syndrome	107.91	15.02	27	9673	1486	79733202
Hyponatraemic seizure	99.63	15.02	21	9679	534	79734154
Recalled product administered	96.13	15.02	22	9678	825	79733863
Renal salt-wasting syndrome	94.30	15.02	21	9679	695	79733993
Pharyngeal haemorrhage	81.59	15.02	21	9679	1295	79733393
Germ cell cancer	69.35	15.02	13	9687	177	79734511
Labelled drug-disease interaction medication error	68.23	15.02	14	9686	311	79734377
Polyuria	58.65	15.02	31	9669	14983	79719705
Blood sodium decreased	55.77	15.02	40	9660	33215	79701473
Poor quality product administered	52.86	15.02	19	9681	3626	79731062
Brain injury	51.38	15.02	26	9674	11491	79723197
Hypopituitarism	50.35	15.02	18	9682	3381	79731307
Neoplasm recurrence	50.17	15.02	19	9681	4195	79730493
Product prescribing error	45.24	15.02	40	9660	44773	79689915
Adrenocortical insufficiency acute	44.65	15.02	16	9684	3027	79731661
Blood sodium increased	44.32	15.02	18	9682	4780	79729908
Tonsillar disorder	40.43	15.02	12	9688	1254	79733434
Inappropriate antidiuretic hormone secretion	38.15	15.02	29	9671	26284	79708404
Apnoeic attack	38.13	15.02	10	9690	664	79734024
Chorioretinopathy	37.58	15.02	13	9687	2218	79732470
Head titubation	34.85	15.02	10	9690	928	79733760
Insulin-like growth factor decreased	34.64	15.02	9	9691	576	79734112
Oligohydramnios	32.20	15.02	13	9687	3399	79731289
Electrolyte imbalance	32.03	15.02	28	9672	30853	79703835
Flushing	31.73	15.02	46	9654	88222	79646466
Oesophageal disorder	31.66	15.02	12	9688	2655	79732033
Urine osmolarity decreased	31.04	15.02	6	9694	97	79734591
Nephrogenic diabetes insipidus	30.48	15.02	11	9689	2123	79732565
Epiphysiolysis	30.03	15.02	6	9694	116	79734572
Duplicate therapy error	29.67	15.02	7	9693	300	79734388
Hyperadrenocorticism	28.62	15.02	7	9693	350	79734338
Insulin-like growth factor increased	27.98	15.02	10	9690	1876	79732812
Polydipsia	26.82	15.02	14	9686	6591	79728097
Abortion induced	25.86	15.02	14	9686	7095	79727593
Contraindicated product prescribed	25.06	15.02	9	9691	1712	79732976
Urine osmolarity increased	24.67	15.02	6	9694	293	79734395
Hypothalamo-pituitary disorder	24.22	15.02	8	9692	1186	79733502
Thoracotomy	24.12	15.02	5	9695	117	79734571
Epistaxis	23.79	15.02	46	9654	111469	79623219
Hypoosmolar state	23.79	15.02	6	9694	341	79734347
Cogwheel rigidity	23.20	15.02	10	9690	3078	79731610
Rebound effect	22.91	15.02	13	9687	7213	79727475
Therapeutic response decreased	22.81	15.02	34	9666	66819	79667869
Reaction to excipient	21.98	15.02	8	9692	1581	79733107
CNS germinoma	21.97	15.02	3	9697	3	79734685
Urine sodium increased	21.53	15.02	5	9695	200	79734488
Headache	21.24	15.02	144	9556	653628	79081060
Hepatitis toxic	21.16	15.02	11	9689	5136	79729552
Joint swelling	20.41	15.02	5	9695	288641	79446047
Cutaneous lupus erythematosus	20.21	15.02	9	9691	2994	79731694
Urine output decreased	20.03	15.02	17	9683	18005	79716683
Drug intolerance	19.83	15.02	4	9696	264115	79470573
Gastrointestinal infection	19.70	15.02	14	9686	11447	79723241
Drug interaction	19.64	15.02	101	9599	415082	79319606
Drug hypersensitivity	19.60	15.02	6	9694	298910	79435778
Product use in unapproved indication	18.80	15.02	70	9630	250289	79484399
Pituitary tumour benign	18.24	15.02	8	9692	2568	79732120
Urinary retention	18.18	15.02	28	9672	56602	79678086
Metastases to pituitary gland	17.94	15.02	3	9697	20	79734668
Akathisia	17.88	15.02	14	9686	13245	79721443
Nasal discomfort	17.75	15.02	10	9690	5473	79729215
Toxic neuropathy	17.63	15.02	6	9694	974	79733714
Generalised tonic-clonic seizure	17.42	15.02	24	9676	43886	79690802
Hyperthermia malignant	17.28	15.02	8	9692	2909	79731779
Pollakiuria	17.28	15.02	22	9678	37295	79697393
Extrapyramidal disorder	16.68	15.02	17	9683	22662	79712026
Foetal growth restriction	16.37	15.02	7	9693	2112	79732576
Arthralgia	16.17	15.02	28	9672	571775	79162913
Pain	16.06	15.02	39	9661	703763	79030925
Rheumatoid arthritis	15.98	15.02	3	9697	208467	79526221
Urine output increased	15.95	15.02	7	9693	2249	79732439
Dihydrotestosterone increased	15.93	15.02	3	9697	42	79734646
Astrocytoma	15.86	15.02	4	9696	227	79734461
Off label use	15.80	15.02	174	9526	907041	78827647
Anticholinergic syndrome	15.66	15.02	8	9692	3603	79731085
Thirst	15.63	15.02	15	9685	18604	79716084
Blood growth hormone increased	15.20	15.02	5	9695	731	79733957
Astrocytoma, low grade	15.17	15.02	3	9697	55	79734633
Brain oedema	15.16	15.02	17	9683	25246	79709442

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	H01BA02	SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES POSTERIOR PITUITARY LOBE HORMONES Vasopressin and analogues
FDA CS	M0022562	Vasopressins
CHEBI has role	CHEBI:33295	diagnostic aid
CHEBI has role	CHEBI:35846	renal agents
CHEBI has role	CHEBI:59727	arginine vasopressin receptor agonist
MeSH PA	D050034	Antidiuretic Agents
MeSH PA	D003029	Coagulants
MeSH PA	D006401	Hematologic Agents
MeSH PA	D006490	Hemostatics
MeSH PA	D045283	Natriuretic Agents
FDA EPC	N0000175905	Vasopressin Analog
FDA PE	N0000175914	Increased Coagulation Factor VIII Activity
FDA PE	N0000175915	Increased Coagulation Factor VIII Concentration
FDA EPC	N0000175916	Factor VIII Activator

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Nocturnal enuresis	indication	8009008
Hereditary factor VIII deficiency disease	indication	28293008	DOID:12134
Polyuria	indication	28442001
von Willebrand disorder	indication	128105004	DOID:12531
Partial Central Diabetes Insipidus	indication
Uremic Bleeding Tendency	off-label use
Psychogenic polydipsia	contraindication	15945005
Hypertensive disorder	contraindication	38341003	DOID:10763
Chronic heart failure	contraindication	48447003
Upper respiratory infection	contraindication	54150009
Allergic rhinitis	contraindication	61582004
Nasal discharge	contraindication	64531003
Nasal congestion	contraindication	68235000
Water intoxication syndrome	contraindication	71785001
Hyponatremia	contraindication	89627008
Cystic fibrosis	contraindication	190905008	DOID:1485
Impaired renal function disorder	contraindication	197663003
Finding of excessive fluid intake	contraindication	267026004
Hereditary von Willebrand disease type 2B	contraindication	359717002
Disorder of coronary artery	contraindication	414024009
Severe Allergic Rhinitis	contraindication

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.65	acidic
pKa2	12.27	acidic
pKa3	12.64	acidic
pKa4	12.94	acidic
pKa5	13.39	acidic
pKa6	13.43	acidic
pKa7	13.8	acidic
pKa8	10.75	Basic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
0.0277MG	NOCDURNA	FERRING PHARMS INC	N022517	June 21, 2018	RX	TABLET	SUBLINGUAL	9220747	May 7, 2023	TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS
0.0277MG	NOCDURNA	FERRING PHARMS INC	N022517	June 21, 2018	RX	TABLET	SUBLINGUAL	9504647	May 7, 2023	TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS
0.0277MG	NOCDURNA	FERRING PHARMS INC	N022517	June 21, 2018	RX	TABLET	SUBLINGUAL	9919025	May 7, 2023	TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS
0.0553MG	NOCDURNA	FERRING PHARMS INC	N022517	June 21, 2018	RX	TABLET	SUBLINGUAL	9220747	May 7, 2023	TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS
0.0553MG	NOCDURNA	FERRING PHARMS INC	N022517	June 21, 2018	RX	TABLET	SUBLINGUAL	9504647	May 7, 2023	TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS
0.0553MG	NOCDURNA	FERRING PHARMS INC	N022517	June 21, 2018	RX	TABLET	SUBLINGUAL	9919025	May 7, 2023	TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS
0.0277MG	NOCDURNA	FERRING PHARMS INC	N022517	June 21, 2018	RX	TABLET	SUBLINGUAL	8802624	Dec. 29, 2023	TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS
0.0553MG	NOCDURNA	FERRING PHARMS INC	N022517	June 21, 2018	RX	TABLET	SUBLINGUAL	8802624	Dec. 29, 2023	TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS
0.0277MG	NOCDURNA	FERRING PHARMS INC	N022517	June 21, 2018	RX	TABLET	SUBLINGUAL	7560429	Feb. 2, 2024	TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS
0.0553MG	NOCDURNA	FERRING PHARMS INC	N022517	June 21, 2018	RX	TABLET	SUBLINGUAL	7560429	Feb. 2, 2024	TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS
0.0277MG	NOCDURNA	FERRING PHARMS INC	N022517	June 21, 2018	RX	TABLET	SUBLINGUAL	11020448	May 21, 2029	TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS, COMPRISING MONITORING A PATIENTS SERUM SODIUM CONCENTRATION
0.0553MG	NOCDURNA	FERRING PHARMS INC	N022517	June 21, 2018	RX	TABLET	SUBLINGUAL	10137167	May 21, 2029	TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS, COMPRISING MONITORING A PATIENTS SERUM SODIUM CONCENTRATION
0.0277MG	NOCDURNA	FERRING PHARMS INC	N022517	June 21, 2018	RX	TABLET	SUBLINGUAL	9974826	April 13, 2030	TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS
0.0553MG	NOCDURNA	FERRING PHARMS INC	N022517	June 21, 2018	RX	TABLET	SUBLINGUAL	9974826	April 13, 2030	TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS, COMPRISING MONITORING A PATIENTS SERUM SODIUM CONCENTRATION
0.00083MG/SPRAY	NOCTIVA	ACERUS PHARMS	N201656	March 3, 2017	DISCN	SPRAY, METERED	NASAL	11419914	June 15, 2030	TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS WHO AWAKEN AT LEAST 2 TIMES PER NIGHT TO VOID BY INDUCING AN ANTIDIURETIC EFFECT BY INTRANASALLY ADMINISTERING A PLUME OF DROPLETS COMPRISING A DOSE OF ABOUT 0.05-5 MCG DESMOPRESSIN
0.00166MG/SPRAY	NOCTIVA	ACERUS PHARMS	N201656	March 3, 2017	DISCN	SPRAY, METERED	NASAL	11419914	June 15, 2030	TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS WHO AWAKEN AT LEAST 2 TIMES PER NIGHT TO VOID BY INDUCING AN ANTIDIURETIC EFFECT BY INTRANASALLY ADMINISTERING A PLUME OF DROPLETS COMPRISING A DOSE OF ABOUT 0.05-5 MCG DESMOPRESSIN

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Vasopressin V2 receptor	GPCR	P30518	V2R_HUMAN	AGONIST	Ki	8.30	CHEMBL	SCIENTIFIC LITERATURE
Vasopressin V1b receptor	GPCR	P47901	V1BR_HUMAN		Ki	9.43	CHEMBL
Oxytocin receptor	GPCR	P30559	OXYR_HUMAN	AGONIST	Ki	7.60	IUPHAR
Vasopressin V1a receptor	GPCR	P37288	V1AR_HUMAN		Ki	8.42	CHEMBL
Oxytocin receptor	GPCR		OXYR_RAT		Ki	9.01	CHEMBL
Vasopressin V1a receptor	GPCR		V1AR_RAT		Ki	7.97	CHEMBL
Vasopressin V1b receptor	GPCR		V1BR_RAT		Ki	9.70	CHEMBL
Vasopressin V2 receptor	GPCR		V2R_RAT		Ki	9.10	CHEMBL

External reference:

ID	Source
4019709	VUID
N0000170340	NUI
D00291	KEGG_DRUG
62357-86-2	SECONDARY_CAS_RN
203658	RXNORM
4018750	VANDF
4019709	VANDF
C0011701	UMLSCUI
CHEBI:4450	CHEBI
CHEMBL376685	ChEMBL_ID
CHEMBL1429	ChEMBL_ID
CHEMBL1200556	ChEMBL_ID
DB00035	DRUGBANK_ID
2182	IUPHAR_LIGAND_ID
3799	INN_ID
ENR1LLB0FP	UNII
5311065	PUBCHEM_CID
1069	MMSL
4548	MMSL
48087	MMSL
772	MMSL
d00583	MMSL
002125	NDDF
004784	NDDF
126189002	SNOMEDCT_US
126190006	SNOMEDCT_US
73454001	SNOMEDCT_US
D003894	MESH_DESCRIPTOR_UI

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Stimate	HUMAN PRESCRIPTION DRUG LABEL	1	0053-6871	SPRAY, METERED	1.50 mg	NASAL	NDA	23 sections
Desmopressin Acetate	HUMAN PRESCRIPTION DRUG LABEL	1	0517-4310	INJECTION, SOLUTION	4 ug	INTRAVENOUS	ANDA	20 sections
Desmopressin Acetate	HUMAN PRESCRIPTION DRUG LABEL	1	0591-2464	TABLET	0.10 mg	ORAL	ANDA	19 sections
Desmopressin Acetate	HUMAN PRESCRIPTION DRUG LABEL	1	0591-2464	TABLET	0.10 mg	ORAL	ANDA	19 sections
Desmopressin Acetate	HUMAN PRESCRIPTION DRUG LABEL	1	0591-2464	TABLET	0.10 mg	ORAL	ANDA	19 sections
Desmopressin Acetate	HUMAN PRESCRIPTION DRUG LABEL	1	0591-2465	TABLET	0.20 mg	ORAL	ANDA	19 sections
Desmopressin Acetate	HUMAN PRESCRIPTION DRUG LABEL	1	0591-2465	TABLET	0.20 mg	ORAL	ANDA	19 sections
Desmopressin Acetate	HUMAN PRESCRIPTION DRUG LABEL	1	0591-2465	TABLET	0.20 mg	ORAL	ANDA	19 sections
Desmopressin acetate	HUMAN PRESCRIPTION DRUG LABEL	1	0703-5051	INJECTION	4 ug	INTRAVENOUS	ANDA	21 sections
Desmopressin acetate	HUMAN PRESCRIPTION DRUG LABEL	1	0703-5054	INJECTION	4 ug	INTRAVENOUS	ANDA	21 sections
Desmopressin Acetate	HUMAN PRESCRIPTION DRUG LABEL	1	10702-169	TABLET	0.10 mg	ORAL	ANDA	11 sections
Desmopressin Acetate	HUMAN PRESCRIPTION DRUG LABEL	1	10702-170	TABLET	0.20 mg	ORAL	ANDA	11 sections
Desmopressin Acetate	Human Prescription Drug Label	1	16714-015	INJECTION, SOLUTION	4 ug	INTRAVENOUS	ANDA	19 sections
Desmopressin Acetate	HUMAN PRESCRIPTION DRUG LABEL	1	16714-883	TABLET	0.10 mg	ORAL	ANDA	19 sections
Desmopressin Acetate	HUMAN PRESCRIPTION DRUG LABEL	1	16714-884	TABLET	0.20 mg	ORAL	ANDA	19 sections
Desmopressin Acetate	HUMAN PRESCRIPTION DRUG LABEL	1	23155-489	TABLET	0.10 mg	ORAL	ANDA	20 sections
Desmopressin Acetate	HUMAN PRESCRIPTION DRUG LABEL	1	23155-489	TABLET	0.10 mg	ORAL	ANDA	20 sections
Desmopressin Acetate	HUMAN PRESCRIPTION DRUG LABEL	1	23155-490	TABLET	0.20 mg	ORAL	ANDA	20 sections
Desmopressin Acetate	HUMAN PRESCRIPTION DRUG LABEL	1	23155-490	TABLET	0.20 mg	ORAL	ANDA	20 sections
Desmopressin Acetate	HUMAN PRESCRIPTION DRUG LABEL	1	24208-342	SOLUTION	0.10 mg	NASAL	ANDA	27 sections
desmopressin acetate	HUMAN PRESCRIPTION DRUG LABEL	1	25021-460	INJECTION, SOLUTION	4 ug	INTRAVENOUS	ANDA	21 sections
desmopressin acetate	HUMAN PRESCRIPTION DRUG LABEL	1	25021-461	INJECTION, SOLUTION	40 ug	INTRAVENOUS	ANDA	20 sections
Desmopressin Acetate	HUMAN PRESCRIPTION DRUG LABEL	1	43598-053	INJECTION, SOLUTION	4 ug	INTRAVENOUS	ANDA	25 sections
DESMOPRESSIN ACETATE	HUMAN PRESCRIPTION DRUG LABEL	1	43598-931	INJECTION	4 ug	SUBCUTANEOUS	ANDA	13 sections
Desmopressin Acetate	Human Prescription Drug Label	1	47335-788	SOLUTION	0.10 mg	NASAL	ANDA	24 sections
Desmopressin Acetate	HUMAN PRESCRIPTION DRUG LABEL	1	50268-220	TABLET	0.10 mg	ORAL	ANDA	19 sections
Desmopressin Acetate	HUMAN PRESCRIPTION DRUG LABEL	1	50268-221	TABLET	0.20 mg	ORAL	ANDA	19 sections
Desmopressin Acetate	HUMAN PRESCRIPTION DRUG LABEL	1	51655-461	TABLET	0.20 mg	ORAL	ANDA	11 sections
NOCDURNA	HUMAN PRESCRIPTION DRUG LABEL	1	54436-325	TABLET	27.70 ug	SUBLINGUAL	NDA	29 sections
NOCDURNA	HUMAN PRESCRIPTION DRUG LABEL	1	54436-350	TABLET	55.30 ug	SUBLINGUAL	NDA	29 sections