Drugs / berberine ursodeoxycholate

Trials 10 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/21 trial
Phase 1/2 NCT03381287 Apr → Dec 2018 hyperlipidemia HighTide Biopharma Pty Ltd Completed No outcome recorded
Phase 26 trials
Phase 2 NCT07496177 Jul 2026 → May 2027 expected chronic kidney disease, type 2 diabetes mellitus Institute of Medicinal Biotechnology, Chinese Academy of Medical Sciences Recruiting No outcome recorded
Phase 2 NCT05623189 Dec 2022 → Apr 2025 metabolic dysfunction-associated steatohepatitis, type 2 diabetes mellitus HighTide Biopharma Pty Ltd Completed No outcome recorded
Phase 2 NCT06411275 Mar 2022 → Jan 2023 type 2 diabetes mellitus HighTide Biopharma Pty Ltd Completed No outcome recorded
Phase 2 NCT04604652 May 2021 → May 2022 cholangitis, cholestasis, primary biliary cholangitis HighTide Biopharma Pty Ltd Completed No outcome recorded
Phase 2 NCT03678480 Mar → Oct 2021 primary sclerosing cholangitis HighTide Biopharma Pty Ltd Withdrawn No outcome recorded
Phase 2 NCT03656744 Nov 2018 → Feb 2020 NAFLD1, metabolic dysfunction-associated steatohepatitis, type 2 diabetes mellitus HighTide Biopharma Pty Ltd Completed No outcome recorded
Phase 33 trials
Phase 3 NCT06415773 Jun 2024 → Jun 2025 type 2 diabetes mellitus HighTide Biopharma Pty Ltd Completed No outcome recorded
Phase 3 NCT06353347 Nov 2023 → Dec 2024 type 2 diabetes mellitus HighTide Biopharma Pty Ltd Completed No outcome recorded
Phase 3 NCT06350890 Nov 2023 → Dec 2024 type 2 diabetes mellitus HighTide Biopharma Pty Ltd Completed No outcome recorded
Also used as a comparator or background therapy in 2 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT03099603 Comparator Mar → Jul 2017 primary sclerosing cholangitis HighTide Biopharma Pty Ltd Completed No outcome recorded
Phase 21 trial
Phase 2 NCT03333928 Comparator Feb 2018 → Apr 2020 primary sclerosing cholangitis HighTide Biopharma Pty Ltd Completed No outcome recorded

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 14 sources stand behind the page.

FieldValueCited text
Known as berberine ursodeoxycholate “Here we report on a prospective, randomised, double-blind, placebo-controlled trial of two doses of HTD1801 (berberine ursodeoxycholate, an ionic salt of berberine and...” PMID 34535644 Sep 2021
2

“Pharmacokinetics and pharmacodynamics of HTD1801 (berberine ursodeoxycholate, BUDCA) in patients with hyperlipidemia.” PMID 33183320 Nov 2020

Berberine ursodeoxycholate (HTD1801) is an ionic salt of berberine and ursodeoxycholic acid with” PMID 36327436 Aug 2022

Known as BUDCA “Pharmacokinetics and pharmacodynamics of HTD1801 (berberine ursodeoxycholate, BUDCA) in patients with hyperlipidemia.” PMID 33183320 Nov 2020
1

“HTD1801 (BUDCA) 250 mg tablets. Dose 1000 mg twice daily with food for 12 weeks.” NCT04604652

Known as HTD1801 “Here we report on a prospective, randomised, double-blind, placebo-controlled trial of two doses of HTD1801 (berberine ursodeoxycholate, an ionic salt of berberine and...” PMID 34535644 Sep 2021
11

“Berberine ursodeoxycholate (HTD1801) is an ionic salt of berberine and ursodeoxycholic acid with” PMID 36327436 Aug 2022

NCT04604652

NCT06350890

NCT05623189

NCT03099603

NCT06415773

NCT06353347

NCT07496177

NCT06411275

NCT03381287

NCT03678480

Known as HTD1801 capsules HTD1801 capsulesNCT05623189
Known as Ursodeoxycholate de berberine ChEMBL registry synonym — accepted as the source's own label CHEMBL5314422
Known as Ursodeoxycholato de berberina ChEMBL registry synonym — accepted as the source's own label CHEMBL5314422
Modality Small molecule “A small molecular compound for the treatment of primary sclerosing cholangitis” NCT03099603
Route Oral “administered orally” NCT06350890