obeticholic acid (ocaliva) Report issue

Small molecule Orphan Drug FDA Approved FDA Fast Track FDA Accelerated Approval FDA Priority Review FDA
AACT ChEMBL DrugBank Drug Central Drugs@FDA KEGG MeSH PubChem

Active Ingredient History

NOW
  • Now
Obeticholic acid (also known as INT-747), is a potent, orally bioavailable farnesoid X receptor (FXR) agonist. The key role of the farnesoid X receptor (FXR) as a regulator of bile and cholesterol metabolism in the liver, with preclinical data from numerous studies providing strong rationale for the advancement of FXR agonists as hepatoprotective therapeutics in chronic liver disease. Obeticholic acid is marketed under the trade name Ocaliva. Ocaliva is specifically indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.   NCATS

Chemistry

  • SMILES: CC[C@H]1[C@@H](O)[C@H]2[C@@H]3CC[C@H]([C@H](C)CCC(O)=O)[C@@]3(C)CC[C@@H]2[C@@]4(C)CC[C@@H](O)C[C@@H]14
  • InChIKey: ZXERDUOLZKYMJM-ZWECCWDJSA-N
  • Mol. Mass: 420.6252
  • ALogP: 5.11
  • ChEMBL Molecule:
    obeticholic acid  
More Chemistry

Pharmacology

  • Mechanism of Action:
  • Multi-specific: Missing data
  • Black Box: Yes
  • Availability: Prescription Only
  • Delivery Methods: Oral
  • Pro Drug: No

Drug Pricing (per unit)

United States

$166.2143 - $222.9703
More Pricing Detail

Note: This drug pricing data is preliminary, incomplete, and may contain errors.

Alternative names

6alpha-ethyl-3alpha,7alpha-dihydroxy-5beta-cholan-24-oic acid | 6alpha-ethyl-chenodeoxycholic acid | 6ecdca | 6-ecdca | 6-ethyl-3,7-dihydroxycholan-24-oic acid | 6-ethyl-cdca | 6-ethyl chenodeoxycholic acid | 6-ethylchenodeoxycholic acid | 6α-ethylchenodeoxycholic acid | cholan-24-oic acid, 6-ethyl-3,7-dihydroxy-, (3alpha,5beta,6alpha,7alpha)- | dsp1747 | dsp-1747 | int747 | int 747 | int-747 | obeticholic acid | ocaliva

Organizations (22)

Research & Development (18)

Organization Org Type FDA approvals Clinical Trials involvement Org ID Force Sort

Marketing (5)

Organization Org Type FDA approvals Clinical Trials involvement Org ID Force Sort

Indications (22)

Approved Indications (1)


 

Liver Cirrhosis, Biliary

Experimental Indications - Clinical Trial Phases 1-4 (22)


 

Adenomatous Polyposis Coli (Phase 2)

Barrett Esophagus (Phase 2)

Bile Acids and Salts (Phase 2)

Biliary Atresia (Phase 2/Phase 3)

Carcinoma (Phase 2)

Cholangitis (Phase 2)

Cholestasis (Phase 1)

Colorectal Neoplasms (Phase 2)

Diabetes Mellitus, Type 2 (Phase 2)

Diarrhea (Phase 2)

Fatty Liver (Phase 2)

Gallstones (Phase 2)

Healthy Volunteers (Phase 1)

Hepatitis, Alcoholic (Phase 2)

Intestinal Polyposis (Phase 2)

Lipodystrophy, Familial Partial (Phase 2)

Liver Cirrhosis (Phase 3)

Liver Cirrhosis, Biliary ()

Liver Diseases (Phase 1)

Non-alcoholic Fatty Liver Disease (Phase 3)

Obesity (Phase 2)

Pruritus (Phase 1)

Overview

  • Highest Phase: Phase 4
  • # of Trials: 36
  • # of Trial Organizations: 18

Trials by Phase

Trial Phase Start Date Organizations Indications

Feedback

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