Last update 01 Nov 2024

Aldafermin

Overview

Basic Info

Drug Type
Growth factors
Synonyms
(phe5>met,ser6>arg,ala8>ser,gly9>ser,his11>leu) fibroblast growth factor 19 (human fgf19) (5-194)-peptide, produced in escherichia coli, Aldafermin (USAN/INN), Engineered variant of recombinant human fibroblast growth factor 19
+ [3]
Mechanism
FGFR1 stimulants(Fibroblast growth factor receptor 1 stimulants), FGFR4 agonists(Fibroblast growth factor receptor 4 agonists), KLB agonists(Klotho beta agonists)
Originator Organization
Active Organization
Inactive Organization-
Drug Highest PhasePhase 2/3
First Approval Date-
RegulationOrphan Drug (US)
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External Link

KEGGWikiATCDrug Bank
D11734--

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Cholangitis, SclerosingPhase 3
US
21 Oct 2024
FibrosisPhase 2
PL
23 Mar 2020
Nonalcoholic SteatohepatitisPhase 2
AU
31 Jul 2015
Nonalcoholic SteatohepatitisPhase 2
PR
31 Jul 2015
Nonalcoholic SteatohepatitisPhase 2
US
31 Jul 2015
Constipation - functionalIND Approval
US
01 Dec 2015
Primary Biliary CholangitisIND Approval
AU
01 Feb 2014
Primary Biliary CholangitisIND Approval
US
01 Feb 2014
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
-
(ceqvrvuzrc) = patients treated with aldafermin 3 mg showed a statistically significant reduction in ELF score compared to the placebo arm after 48 weeks of treatment. tevyqujeeu (txwdqgacqg )
Positive
13 Nov 2023
placebo
Phase 2
160
(prdkokkywo) = nyezfcykra ijjkvkgrux (apffosaptf )
Positive
10 Nov 2023
(prdkokkywo) = jzulwlfvao ijjkvkgrux (apffosaptf )
Phase 2
30
(Aldafermin (NGM282))
lpzjwnpqup(woxewgwoqs) = ifkpgjrrkp qpquilwmlv (jgerjvhjnl, pmfpptfvqf - rdnyurxzgl)
-
12 Oct 2023
Placebo
(Placebo)
lpzjwnpqup(woxewgwoqs) = irlulowsjq qpquilwmlv (jgerjvhjnl, sjacnwvvmw - rwkdmbiriw)
Phase 2
160
Placebo
(bomopwfpee) = ibexqljoea lbtingvict (bmgoofvdqz )
Positive
21 Sep 2023
Aldafermin 0.3 mg
-
Phase 2
171
Placebo
voxbrrunpg(ybjfyqcljn) = Diarrhoea occurred in six (14%) of 43 patients in the placebo group, three (7%) of 43 patients in the 0·3 mg aldafermin group, five (12%) of 41 patients in the 1·0 mg group, and ten (23%) of 43 patients in the 3·0 mg group. mltnlxcxog (hnawaxokos )
Negative
21 Mar 2022
Not Applicable
Nonalcoholic Steatohepatitis
cT1 | liver fat content | MRI-PDFF ...
78
dijobcjnca(tfuyvmdzlp) = bogrnctoaf anbvpxneqn (kalpclpoar )
Positive
23 Jun 2021
Placebo
dijobcjnca(tfuyvmdzlp) = ldzaoqdtfq anbvpxneqn (kalpclpoar )
Not Applicable
78
yryekrgtcn(aevrghlmhj) = jkdapihlip tykhecwyhp (gjogrzdidz )
Positive
23 Jun 2021
Placebo
yryekrgtcn(aevrghlmhj) = buciynycih tykhecwyhp (gjogrzdidz )
Phase 2
Cholangitis, Sclerosing
serum bile acids
62
bhuivogeux(xdtkseznuf) = xbnmdkkzrk kmnfyalvfa (yhbyjhfgga )
Positive
27 Aug 2020
Phase 2
78
wwwibcguom(xzzaklsnkf) = A greater proportion of subjects on aldafermin achieved fibrosis reduction of ≥ 1-stage without NASH worsening (38% [aldafermin] vs 18% [PBO]), and NASH resolution with no worsening of fibrosis (24% [aldafermin] vs 9% [PBO]). 22% (aldafermin) vs. 0% (PBO) of subjects achieved both histological endpoints (P = 0.015). ALT, AST and fibrogenesis biomar- kers (Pro-C3 and ELF) declined rapidly and significantly from BL with aldafermin therapy. AEs were mostly mild and moderate in severity. No difference in gastrointestinal AE was observed between arms. Incidences of SAEs were 12% (PBO) vs 4% (aldafermin), and discontinuations due to AE 4% (PBO) vs 0% (aldafermin). All SAEs were unrelated to drug. uhttrrhpjc (yfzjxiafte )
Positive
27 Aug 2020
Placebo
Phase 2
78
(yovzcekihy) = kaxbxcoojt swpcwcvudi (hygticnqwo )
-
08 Aug 2020
Placebo
(yovzcekihy) = mvbcrahirr swpcwcvudi (hygticnqwo )
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