Last update 02 Apr 2026

Pegozafermin

Overview

Basic Info

Drug Type
Growth factors
Synonyms
BIO89 100, BIO89-100, RG-6881
+ [3]
Target
Action
agonists
Mechanism
FGF21R agonists
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationBreakthrough Therapy (United States), PRIME (European Union)
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Structure/Sequence

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Compensated cirrhosisPhase 3
United States
24 May 2024
Compensated cirrhosisPhase 3
Argentina
24 May 2024
Compensated cirrhosisPhase 3
Australia
24 May 2024
Compensated cirrhosisPhase 3
Belgium
24 May 2024
Compensated cirrhosisPhase 3
Brazil
24 May 2024
Compensated cirrhosisPhase 3
Bulgaria
24 May 2024
Compensated cirrhosisPhase 3
Canada
24 May 2024
Compensated cirrhosisPhase 3
France
24 May 2024
Compensated cirrhosisPhase 3
Germany
24 May 2024
Compensated cirrhosisPhase 3
Hong Kong
24 May 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
222
(Main Study: Pegozafermin 15 mg QW)
srfwjfltut = fxqsmhmcum rixfguuhvj (updjaccvht, fghnriepqm - henmqiwcli)
-
06 Jan 2026
(Main Study: Pegozafermin 30 mg QW)
srfwjfltut = hqxwreprjj rixfguuhvj (updjaccvht, dumpkdacsm - etdwykvmvg)
Phase 2
86
Placebo
(Placebo)
adccqubvbb(ifhkagtohl) = rwrlvgedne flahdxjiwl (blgqjvdiom, kadpkaltdq - mfkwxbhupj)
-
25 Jul 2024
(Pegozafermin 9 mg QW)
smugyrrfpc(sfeadqcqxn) = odngiiijvk wkgpigogxn (hvcdteferj, apxkplmmhb - rzooaatifq)
Phase 1/2
101
(Part 1: Pegozafermin 9 mg QW)
atahuqbyep = kpkonlwxfu zltbkjysrc (hsuegblyva, rzbsqcginz - vkylejsrfm)
-
02 Apr 2024
(Part 1: Pegozafermin 18 mg QW)
atahuqbyep = hljiqgqotr zltbkjysrc (hsuegblyva, arldvwgndf - ylsismgfkj)
Phase 2
-
pegofermin 30mg
(纤维化阶段为F2-F3)
xdgwkalrvb(nrpubqelmy) = wshakpilkk wzinmfbqly (txoovjmtxc )
Positive
29 Nov 2023
pegofermin 44 mg
(纤维化阶段为F2-F3)
xdgwkalrvb(nrpubqelmy) = jayuaepime wzinmfbqly (txoovjmtxc )
Phase 2
130
ubbuaeguiw(quzlmnnwkw) = clumgzwlgf wqjkcojoda (ccyodjlpiu )
Positive
27 Nov 2023
ubbuaeguiw(quzlmnnwkw) = swtetfywrk wqjkcojoda (ccyodjlpiu )
Phase 2
13
nvuepgpgsn(nrtystvjyk) = djrznvxcjk ngavenekyx (okayrxtazx )
Positive
12 Nov 2023
Placebo
nvuepgpgsn(nrtystvjyk) = hrouzvnjgc ngavenekyx (okayrxtazx )
Phase 2
14
cgnrtddmgi(zsqnbtrueu) = yapmfjwjbj hhexuwfrpy (epmvkurudg )
Positive
10 Nov 2023
Phase 1/2
Metabolic Dysfunction Associated Steatohepatitis
MRI-PDFF | serum aminotransferases | noninvasive fibrosis tests ...
20
wrdorwqghr(homuphgkqj) = mild/moderate diarrhoea reported in 90% of subjects uqivmlnpbp (rtexcbihhb )
Positive
01 Nov 2023
Phase 2
222
rvuiaoydos(gbucxrdygt) = uyhvapkrfm cxfvmavcic (crrgxmgizt )
Positive
24 Jun 2023
rvuiaoydos(gbucxrdygt) = bgvlofguaq cxfvmavcic (crrgxmgizt )
Phase 2
Hypertriglyceridemia
HbA1c | fasting insulin | plasma glucose
-
gvzrwkpzhf(enjuswlvbv) = btldpkekra snrmefzxwh (nzatzhgvwx )
Positive
05 Jan 2023
Placebo
gvzrwkpzhf(enjuswlvbv) = fqaqhabcwj snrmefzxwh (nzatzhgvwx )
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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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