Ursodiol

Bile Acid — ALIMENTARY TRACT AND METABOLISM

Key facts

Ursodiol is an ofp drug in the Bile Acid class catalogued in DrugCentral. It was first approved by the FDA in 1987. DrugCentral lists 8 molecular targets, including CISD1, GPBAR1 and M1-family alanyl aminopeptidase. Recorded indications include Calculus in biliary tract, Cholelithiasis Prevention and Primary biliary cirrhosis.

• Approval status: ofp (first approved 1987 by the FDA).
• Drug class: Bile Acid.
• Molecular targets: CISD1, GPBAR1, M1-family alanyl aminopeptidase and SLC10A1 (8 listed in DrugCentral).
• Indications: Calculus in biliary tract, Cholelithiasis Prevention and Primary biliary cirrhosis.
• ATC code: A05AA02 (Bile acids and derivatives).
• Molecular formula: C24H40O4; molecular weight 392.58 g/mol.

Indications & contraindications

Drug–disease relationships curated by DrugCentral (OMOP / SNOMED concepts).

Indications (3)

• Calculus in biliary tract
• Cholelithiasis Prevention
• Primary biliary cirrhosis

Mechanism & targets

• Established pharmacologic class: Bile Acid

Molecular targets (8)

Target	Gene	Action	Activity
CDGSH iron-sulfur domain-containing protein 1	CISD1	unknown	Ki 5.95
G-protein coupled bile acid receptor 1	GPBAR1	unknown	EC50 5.62
M1-family alanyl aminopeptidase	—	unknown	IC50 5.59
Sodium/bile acid cotransporter	SLC10A1	inhibitor	IC50 5.44
Phospholipase A2	PLA2G1B	unknown	Kd 5.00
Ectonucleotide pyrophosphatase/phosphodiesterase family member 2	ENPP2	unknown	IC50 4.99
Bile acid receptor	NR1H4	agonist	IC50 4.17
Aldo-keto reductase family 1 member C2	AKR1C2	unknown	—

Regulatory approvals (1)

Date	Agency	Marketed as	Applicant	Orphan
1987-12-31	FDA	—	ACTAVIS LABS UT INC	Yes

ATC classification

ATC code	Therapeutic hierarchy
A05AA02	ALIMENTARY TRACT AND METABOLISM › BILE AND LIVER THERAPY › BILE THERAPY › Bile acids and derivatives

Reported adverse-event signals

Strongest FDA FAERS disproportionality signals (log-likelihood ratio). A signal is a statistical association in spontaneous reports, not proof that the drug causes the event.

MedDRA term	LLR
Venoocclusive liver disease	844.6
Hepatic function abnormal	782.0
Hepatic failure	599.1
Blood bilirubin increased	584.3
Hepatic encephalopathy	527.3
Ascites	500.1
Venoocclusive disease	492.5
Aplastic anaemia	488.3
Hepatocellular carcinoma	413.1
Infective pulmonary exacerbation of cystic fibrosis	390.4
Aspartate aminotransferase increased	385.2
Cholangitis	366.5

Chemical structure

• Molecular formula: C₂₄H₄₀O₄
• Molecular weight: 392.58 g/mol
• CAS number: —
• InChIKey: RUDATBOHQWOJDD-UZVSRGJWSA-N
• PubChem CID: 31401

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@]12C

Frequently asked questions

Answers are generated from the structured data on this page, not written by hand.

What is Ursodiol used for?

DrugCentral lists the following indications for Ursodiol: Calculus in biliary tract, Cholelithiasis Prevention and Primary biliary cirrhosis.

How does Ursodiol work?

Its molecular targets in DrugCentral include CISD1, GPBAR1, M1-family alanyl aminopeptidase and SLC10A1 (inhibitor).

When was Ursodiol first approved?

Ursodiol was first approved by the FDA in 1987.

What drug class does Ursodiol belong to?

Ursodiol is in the Bile Acid class.

What is the chemical formula of Ursodiol?

Ursodiol has the molecular formula C24H40O4 and a molecular weight of 392.58 g/mol.

Sources

• DrugCentral drug card 2797 — structure, indications, targets, approvals, pharmacologic classes (CC BY-SA 4.0)
• ChEMBL CHEMBL1551 — compound record and bioactivity
• PubChem CID 31401 — chemical identifiers
• DrugBank DB01586 — drug record
• FDA UNII 724L30Y2QR — substance identity
• DailyMed: FDA labels for Ursodiol — current prescribing information (label search)
• UniProt Q9NZ45 (CISD1) — target protein
• UniProt Q8TDU6 (GPBAR1) — target protein
• UniProt Q14973 (SLC10A1) — target protein
• UniProt P04054 (PLA2G1B) — target protein
• UniProt Q13822 (ENPP2) — target protein
• UniProt Q96RI1 (NR1H4) — target protein
• FDA Adverse Event Reporting System (openFDA FAERS) — adverse-event signals, as aggregated by DrugCentral

How this page is built: methodology · editorial policy & corrections.