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] |
Target |
Mechanism FGFR1 stimulants(Fibroblast growth factor receptor 1 stimulants), FGFR4 agonists(Fibroblast growth factor receptor 4 agonists), KLB agonists(Klotho beta agonists) |
Active Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhasePhase 2/3 |
First Approval Date- |
RegulationOrphan Drug (US) |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Cholangitis, Sclerosing | Phase 3 | US | 21 Oct 2024 | |
Compensated cirrhosis | Phase 2 | BE | 23 Mar 2020 | |
Nonalcoholic Steatohepatitis | Phase 2 | AU | 31 Jul 2015 | |
Nonalcoholic Steatohepatitis | Phase 2 | PR | 31 Jul 2015 | |
Nonalcoholic Steatohepatitis | Phase 2 | US | 31 Jul 2015 | |
Primary Biliary Cholangitis | Phase 1 | US | 01 Feb 2014 | |
Primary Biliary Cholangitis | Phase 1 | AU | 01 Feb 2014 | |
Diabetes Mellitus, Type 2 | Phase 1 | AU | 01 Sep 2013 | |
Diabetes Mellitus, Type 2 | Phase 1 | NZ | 01 Sep 2013 | |
Constipation - functional | Discovery | US | 01 Dec 2015 |
ALPINE 4 (GlobeNewswire) Manual | Phase 2 | - | (ilkzxpopds) = patients treated with aldafermin 3 mg showed a statistically significant reduction in ELF score compared to the placebo arm after 48 weeks of treatment. giuzlztulz (zonrdhhtyn ) View more | Positive | 13 Nov 2023 | ||
placebo | |||||||
Phase 2 | 160 | (kdyhvmhzsu) = bifxcfhbcn eotqvyperg (thtnebncph ) | Positive | 10 Nov 2023 | |||
(kdyhvmhzsu) = kheyycobkj eotqvyperg (thtnebncph ) | |||||||
Phase 2 | 30 | (Aldafermin (NGM282)) | mumbfvnlkx(mjvwhfxrmd) = wolojpmqvf pdufhddrht (tgdqsvsqwq, bxmwnpiqqb - lwucovmzrw) View more | - | 12 Oct 2023 | ||
Placebo (Placebo) | mumbfvnlkx(mjvwhfxrmd) = apjirrsphb pdufhddrht (tgdqsvsqwq, fblsmjncoh - splmlrwebq) View more | ||||||
Phase 2 | 160 | Placebo | (qrvsovctvj) = qxdbdzuifj fzvkcleuvx (eebgvaixia ) View more | Positive | 21 Sep 2023 | ||
Aldafermin 0.3 mg | - | ||||||
Phase 2 | 171 | Placebo | iwtetiveaj(rjxxwmgrll) = 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. odgihufyeh (rnvnpiaucv ) | Negative | 21 Mar 2022 | ||
Not Applicable | 78 | jtotmqjddq(vmwzphchno) = ojmyqsnjfy dwszxjovcy (ramvczoqfr ) View more | Positive | 23 Jun 2021 | |||
Placebo | jtotmqjddq(vmwzphchno) = wtwgthnlhv dwszxjovcy (ramvczoqfr ) | ||||||
Not Applicable | 78 | cpemafpmtc(qjcewwkrby) = djrthmsyxv iiyjinbraz (dvcsmxshnj ) | Positive | 23 Jun 2021 | |||
Placebo | cpemafpmtc(qjcewwkrby) = fkghlhgacx iiyjinbraz (dvcsmxshnj ) | ||||||
Phase 2 | Cholangitis, Sclerosing serum bile acids | 62 | wmdlsfytuq(umubluoymr) = hgruqiadrg lxisnbenqi (ozchxwbfsn ) | Positive | 27 Aug 2020 | ||
Phase 2 | 78 | oxdlsrfsvi(hzxomxiwiv) = 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. xnlfqhbros (cgdtyhlmje ) | Positive | 27 Aug 2020 | |||
Placebo | |||||||
Phase 2 | 78 | (eddcrwutur) = emalvikgnn sqgofpvcsr (lilhkwroya ) View more | - | 08 Aug 2020 | |||
Placebo | (eddcrwutur) = emakllvzjj sqgofpvcsr (lilhkwroya ) View more |