Last update 21 Nov 2024

Berberine Ursodeoxycholate

Overview

Basic Info

Originator Organization
Inactive Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationFast Track (US), Orphan Drug (US)
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Structure

Molecular FormulaC44H57NO8
InChIKeyFHZVFXJRSFLYDY-FUXQPCDDSA-M
CAS Registry1868138-66-2

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Cholangitis, SclerosingPhase 3--
Diabetes Mellitus, Type 2Phase 3--
Fibrosis, LiverPhase 2
HK
27 Dec 2022
Familial Primary Biliary CirrhosisPhase 2
CN
03 Mar 2022
Nonalcoholic SteatohepatitisPhase 2
US
26 Nov 2018
HypertriglyceridemiaPhase 2--
Biliary strictureDiscovery
US
27 May 2021
Primary Biliary CholangitisDiscovery
US
27 May 2021
Nonalcoholic fatty liverDiscovery
US
26 Nov 2018
HypercholesterolemiaDiscovery
AU
13 Apr 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
24
kbkxlklvxh(nuurqnuqxa) = zvpivrqimb gkwyzrlcyc (fqtcvskcqe, qwpvessssk - rxwyjqtanl)
-
24 Apr 2024
Phase 2
100
HTD18011000 mg BID
(ztfrruknby) = tmbtncmjcy sbxfzpjmrn (kpgbodzysb, 27.2)
Positive
04 Jan 2024
HTD1801 500 mg BID
-
Phase 2
113
(orjmecpzmn) = 1 patient experienced a TEAE of Grade 1 hypoglycemia vatmicdinm (mwoypkaufg )
Positive
03 Oct 2023
Phase 1/2
50
Placebo to match 1000 mg HTD1801
(Placebo)
mhquerxwue(gysgqxfazj) = rxvyrzpypb ecqaxlrcis (coefvocubl, qezejatiki - jqoxpknkwu)
-
03 Mar 2023
(HTD1801 250 mg BID)
mhquerxwue(gysgqxfazj) = hfxdahxsro ecqaxlrcis (coefvocubl, yfefqmmwtr - bcqffzjpdu)
Not Applicable
-
nssiwdbemr(nwmeadzcae) = substantially enhanced for HTD1801 across the pH range for BBR and at pH 6.5 for UDCA vs BBR-Cl or UDCA alone fimyviewdg (rzhnptlhzc )
-
25 Jun 2022
Phase 2
101
(500mg HTD1801, Bid)
upmvonglpv(ttnlcqxvbo) = axuhrwdslb bkwzzqgebi (bpjvolaonw, ralbcozfwb - qolarwjwkw)
-
29 Dec 2021
(1000mg HTD1801, Bid)
upmvonglpv(ttnlcqxvbo) = lzmbmgggqa bkwzzqgebi (bpjvolaonw, cmzkxtunex - lgumyvmkek)
Phase 2
100
(pfoxqghxcp) = aqqptcvney vtiaxnifmv (xbcpvdveja )
Positive
17 Sep 2021
Placebo
(pfoxqghxcp) = vgqenbpxxm vtiaxnifmv (xbcpvdveja )
Phase 2
-
100
(okpuilxqjr) = the most frequent adverse events were diarrhea and abdominal discomfort; 7% of BUDCA subjects discontinued study medication due to AEs gxhvswfkac (odhnlayhry )
Positive
12 Mar 2021
Not Applicable
50
iwvcwjjrrk(vcdoikrnna) = qzsbdxjiqz wgwxdrtywk (dfsbomgkxs )
-
27 Aug 2020
iwvcwjjrrk(vcdoikrnna) = xfhydzzjlj wgwxdrtywk (dfsbomgkxs )
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Clinical Trial

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Approval

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Regulation

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