Ursodiol - PharmaKB

Ursodiol

Actigall, Urso, Ursodiol (ursodiol) is a small molecule pharmaceutical. Ursodiol was first approved as Actigall on 1987-12-31. It is used to treat biliary liver cirrhosis and cholelithiasis in the USA.

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Events Timeline

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
digestive system diseases	D004066
signs and symptoms pathological conditions	D013568

Trade Name

FDA

EMA

Actigall, Ursodiol (discontinued: Actigall, Urso, Ursodiol)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Ursodiol

Tradename	Company	Number	Date	Products
ACTIGALL	Teva	N-019594 RX	1987-12-31	1 products, RLD, RS

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Labels

FDA

EMA

Brand Name	Status	Last Update
festal plus	unapproved drug other	2018-11-22
reltone 200 mg reltone 400 mg	ANDA	2023-01-16
urso 250 urso forte	New Drug Application	2023-01-12
urso urso forte		2008-05-27
ursodiol	ANDA	2025-12-05
ursodiol 200 mg ursodiol 400 mg	ANDA	2024-11-26
ursodiol capsules	ANDA	2010-05-25
urusa	unapproved drug other	2018-11-19

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
biliary liver cirrhosis	—	D008105	K74.3
cholelithiasis	EFO_0004799	D002769	K80

Agency Specific

FDA

EMA

No data

Patent Expiration

No data

ATC Codes

A: Alimentary tract and metabolism drugs

— A05: Bile and liver therapy drugs

— A05A: Bile therapy drugs

— A05AA: Bile acids and derivatives for bile therapy

— A05AA02: Ursodeoxycholic acid

HCPCS

No data

Clinical

Clinical Trials

222 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Biliary liver cirrhosis	D008105	—	K74.3	4	27	31	8	14	78
Cholangitis	D002761	HP_0030151	K83.0	4	14	13	5	12	42
Fibrosis	D005355	—	—	4	10	11	1	9	33
Liver cirrhosis	D008103	EFO_0001422	K74.0	5	8	11	1	6	29
Liver diseases	D008107	EFO_0001421	K70-K77	2	8	2	3	6	18
Type 2 diabetes mellitus	D003924	EFO_0001360	E11	1	3	5	2	1	11
Gallstones	D042882	EFO_0004210	—	—	—	2	5	3	10
Hepatitis	D006505	—	K75.9	—	2	1	2	4	9
Diabetes mellitus	D003920	EFO_0000400	E08-E13	—	4	4	2	1	9
Non-alcoholic fatty liver disease	D065626	EFO_0003095	K75.81	—	2	—	3	4	9

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Cholestasis	D002779	—	K83.1	—	6	7	—	4	14
Healthy volunteers/patients	—	—	—	7	—	1	—	1	9
Intrahepatic cholestasis	D002780	—	—	—	4	4	—	1	7
Sclerosing cholangitis	D015209	EFO_0004268	K83.01	3	3	2	—	1	7
Hepatitis a	D006506	EFO_0007305	B15	—	2	1	—	2	5
Colorectal neoplasms	D015179	—	—	1	4	2	—	—	5
Digestive system diseases	D004066	EFO_0000405	K92.9	1	3	1	—	—	4
Neoplasms	D009369	—	C80	—	1	1	—	2	3
Pregnancy complications	D011248	—	—	—	1	2	—	1	3
Glucose intolerance	D018149	HP_0000833	R73.03	1	1	1	—	1	3

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Covid-19	D000086382	—	U07.1	1	2	—	—	3	5
Gastrointestinal diseases	D005767	—	—	1	3	—	—	—	3
Cardiomyopathies	D009202	EFO_0000318	I42	—	1	—	—	1	2
Disease progression	D018450	—	—	—	1	—	—	1	2
Amyloidosis	D000686	EFO_1001875	E85	—	1	—	—	1	2
Chronic chemical and drug induced liver injury	D056487	EFO_1000905	—	2	2	—	—	—	2
Rheumatoid arthritis	D001172	EFO_0000685	M06.9	—	2	—	—	—	2
Arthritis	D001168	EFO_0005856	M05-M14	—	2	—	—	—	2
Biliary tract diseases	D001660	EFO_0009534	K83.9	1	2	—	—	—	2
Parkinson disease	D010300	EFO_0002508	G20	1	1	—	—	—	2

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Clostridium infections	D003015	EFO_1000874	A05.2	1	—	—	—	1	2
Colonic neoplasms	D003110	—	C18	1	—	—	—	—	1
Rectal neoplasms	D012004	—	—	1	—	—	—	—	1
Liver function tests	D008111	—	—	1	—	—	—	—	1
Gastric bypass	D015390	EFO_0005244	—	1	—	—	—	—	1
Aging	D000375	GO_0007568	R41.81	1	—	—	—	—	1
Huntington disease	D006816	Orphanet_399	G10	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Alcoholic fatty liver	D005235	—	K70.0	—	—	—	—	2	2
Infections	D007239	EFO_0000544	—	—	—	—	—	2	2
Communicable diseases	D003141	—	—	—	—	—	—	2	2
Transjugular intrahepatic portasystemic shunt	D019168	—	—	—	—	—	—	2	2
Peroxisomal disorders	D018901	Orphanet_44	E71.5	—	—	—	—	1	1
Zellweger syndrome	D015211	Orphanet_912	E71.510	—	—	—	—	1	1
Infantile refsum disease	D052919	Orphanet_772	G60.1	—	—	—	—	1	1
Adrenoleukodystrophy	D000326	Orphanet_43	E71.52	—	—	—	—	1	1
Refsum disease	D012035	Orphanet_773	G60.1	—	—	—	—	1	1
Immunoglobulin light-chain amyloidosis	D000075363	—	—	—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Ursodiol
INN	ursodeoxycholic acid
Description	Ursodeoxycholic acid is a bile acid found in the bile of bears (Ursidae) as a conjugate with taurine. Used therapeutically, it prevents the synthesis and absorption of cholesterol and can lead to the dissolution of gallstones. It has a role as a human metabolite and a mouse metabolite. It is a bile acid, a dihydroxy-5beta-cholanic acid and a C24-steroid. It is a conjugate acid of an ursodeoxycholate.
Classification	Small molecule
Drug class	—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	C[C@H](CCC(=O)O)[C@H]1CC[C@H]2[C@@H]3[C@@H](O)C[C@@H]4C[C@H](O)CC[C@]4(C)[C@H]3CC[C@@]21C