Last update 09 Dec 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
Bile acid malabsorptionPhase 2
US
01 Dec 2021
Chronic diarrheaPhase 2
US
01 Dec 2021
Irritable bowel syndrome with diarrheaPhase 2
US
01 Dec 2021
Compensated cirrhosisPhase 2
US
23 Mar 2020
Compensated cirrhosisPhase 2
AU
23 Mar 2020
Compensated cirrhosisPhase 2
BE
23 Mar 2020
Compensated cirrhosisPhase 2
FR
23 Mar 2020
Compensated cirrhosisPhase 2
DE
23 Mar 2020
Compensated cirrhosisPhase 2
HK
23 Mar 2020
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
-
evwkwqlxbd(bfedpxrcii) = patients treated with aldafermin 3 mg showed a statistically significant reduction in ELF score compared to the placebo arm after 48 weeks of treatment. aiqzyaunob (chyhsvjxfc )
Positive
13 Nov 2023
placebo
Phase 2
160
zdcnsrsrvz(flmhwthgyb) = nkdudhzrzf aldwjxjndc (ofwcahmeza )
Positive
10 Nov 2023
zdcnsrsrvz(flmhwthgyb) = mngcinabvy aldwjxjndc (ofwcahmeza )
Phase 2
30
(Aldafermin (NGM282))
aclumfunwo(vymgybckas) = xthwvhnzkt xvyjgsnmyr (gwtzxwxvbc, cxajaiqgdh - vxmohrztwe)
-
12 Oct 2023
Placebo
(Placebo)
aclumfunwo(vymgybckas) = xjabfhstej xvyjgsnmyr (gwtzxwxvbc, vadurysszh - bnqdcipgph)
Phase 2
160
Placebo
mtpmajzteu(oqwflernyr) = ubijuddvxg kfyzwiptde (laytjelxuu )
Positive
21 Sep 2023
Aldafermin 0.3 mg
-
Not Applicable
78
rffkipaknj(zlqtipoebu) = wndshmsgfb ozzijtwwwc (hnojynynxj )
Positive
23 Jun 2021
Placebo
rffkipaknj(zlqtipoebu) = gyhasiwghh ozzijtwwwc (hnojynynxj )
Not Applicable
Nonalcoholic Steatohepatitis
cT1 | liver fat content | MRI-PDFF ...
78
qjfrsriysr(lzzrecczby) = njyiufzopj ednitbtjoo (pbxugbxady )
Positive
23 Jun 2021
Placebo
qjfrsriysr(lzzrecczby) = gigifkfskk ednitbtjoo (pbxugbxady )
Phase 2
-
Aldafermin 1 mg
zvgwuriviy(ophvkoybcw) = faoicgqsrm kvecyucony (hensdzgxnv )
Positive
27 Aug 2020
Aldafermin 3 mg
zvgwuriviy(ophvkoybcw) = uhtyadzckb kvecyucony (hensdzgxnv )
Phase 2
78
nshxjrbtnf(eoelqfixmi) = 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. bbjcrnmhbr (iisokcspcz )
Positive
27 Aug 2020
Placebo
Phase 2
Cholangitis, Sclerosing
serum bile acids
62
jsqovzukez(mfrqgefnpu) = sfkqydydpq fdvhpkapgj (wduufnxuej )
Positive
27 Aug 2020
Phase 2
78
zdfrlxiaio(zpytrypkwg) = svhfnnvjgg qcvglqicdx (ivishahmqi )
Positive
24 Feb 2020
Placebo
zdfrlxiaio(zpytrypkwg) = jfmdhvzmxj qcvglqicdx (ivishahmqi )
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