drugset
Drugs / berberine ursodeoxycholate
last change Jul 2026 re-read 9 days ago

berberine ursodeoxycholate

also known as HTD1801 · BUDCA · HTD1801 capsules · Ursodeoxycholate de berberine · Ursodeoxycholato de berberina

Small molecule

Developed for
type 2 diabetes mellitus · metabolic dysfunction-associated steatohepatitis · chronic kidney disease · hyperlipidemia · NAFLD1 · primary biliary cholangitis · primary sclerosing cholangitis
Investigated by
HighTide Biopharma Pty Ltd · Shenzhen HighTide Biopharmaceutical Ltd. · Institute of Medicinal Biotechnology, Chinese Academy of Medical Sciences · Weifang People's Hospital

Trials 10

today NCT07496177 · Ph 2 NCT06415773 · Ph 3 NCT06353347 · Ph 3 NCT06350890 · Ph 3 NCT05623189 · Ph 2 NCT06411275 · Ph 2 NCT04604652 · Ph 2 NCT03678480 · Ph 2 NCT03656744 · Ph 2 NCT03381287 · Ph 1/2
201920202021202220232024202520262027
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 · 2 met primary
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 Met primary
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Phase 2 NCT03678480 Mar → Oct 2021 primary sclerosing cholangitis HighTide Biopharma Pty Ltd Withdrawn No outcome recorded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 Met primary
Phase 33 trials · 1 met primary
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 Met primary
Phase 3 NCT06350890 Nov 2023 → Dec 2024 type 2 diabetes mellitus HighTide Biopharma Pty Ltd Completed No outcome recorded
Comparator or background therapy2 trials
Phase 1 NCT03099603 Comparator Mar → Jul 2017 primary sclerosing cholangitis HighTide Biopharma Pty Ltd Completed No outcome recorded
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

NCT06411275 ↗

NCT06353347 ↗

NCT07496177 ↗

NCT03678480 ↗

NCT04604652 ↗

NCT03099603 ↗

NCT03381287 ↗

NCT06350890 ↗

NCT06415773 ↗

Show 1 more source
Known as HTD1801 capsules “HTD1801 capsules” NCT05623189 ↗
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 ↗