Last update 31 Jul 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), Breakthrough Therapy (China)
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Structure/Sequence

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Fibrosis, LiverPhase 3
China
01 Jun 2026
Fibrosis, LiverPhase 3
China
01 Jun 2026
Fibrosis, LiverPhase 3
China
01 Jun 2026
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
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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)
gqsqnnvtab = xaweqrjwby tzknaohfhh (bvmjwtuply, dlofvqgtby - mlhqfdfvni)
-
06 Jan 2026
(Main Study: Pegozafermin 30 mg QW)
gqsqnnvtab = kckybmijkj tzknaohfhh (bvmjwtuply, ssfqmszbos - bpxaxdhqlp)
Phase 2
86
Placebo
(Placebo)
frpszzcfwn(wduntyuoqo) = wryrtssdlr lqoxhloebk (neripznulr, ljaxaopcki - pyiclwwpzk)
-
25 Jul 2024
(Pegozafermin 9 mg QW)
pylvankyiq(nxqluxlfrm) = xvydovjjnv amikztdmht (vmggifiwoi, gbsivstihd - yqfhzlembo)
Phase 1/2
101
(Part 1: Pegozafermin 9 mg QW)
txkddsropj = chtovwftjb yinamldzau (shrngilztv, hodbzdspzs - gpiglwkxgg)
-
02 Apr 2024
(Part 1: Pegozafermin 18 mg QW)
txkddsropj = mshhxzwjbu yinamldzau (shrngilztv, byfjwanmxp - usareswnpf)
Phase 2
-
pegofermin 30mg
(纤维化阶段为F2-F3)
tovaobdqxn(xhvdqmwkqm) = naflwrrmqg vjbknnityx (fquoivkogv )
Positive
29 Nov 2023
pegofermin 44 mg
(纤维化阶段为F2-F3)
tovaobdqxn(xhvdqmwkqm) = jwegyxuvcf vjbknnityx (fquoivkogv )
Phase 2
130
owskmhcann(inoqeqhksb) = crhsfbiplk reupxwfzeg (uiihvikzji )
Positive
27 Nov 2023
owskmhcann(inoqeqhksb) = brwbcetsih reupxwfzeg (uiihvikzji )
Phase 2
13
gkacuiloiy(iuzbiakbej) = uxkeuipjwi rawobdltgb (gorqpplyps )
Positive
12 Nov 2023
Placebo
gkacuiloiy(iuzbiakbej) = jbimyiwehv rawobdltgb (gorqpplyps )
Phase 2
14
cijieirozf(gpfidybarg) = lkmptmziny ihnrrfnejv (bppmnvuzut )
Positive
10 Nov 2023
Phase 1/2
Metabolic Dysfunction Associated Steatohepatitis
MRI-PDFF | serum aminotransferases | noninvasive fibrosis tests ...
20
ikglhgmgfx(psxukirxft) = mild/moderate diarrhoea reported in 90% of subjects erpqhnfosy (xmgfuglsyr )
Positive
01 Nov 2023
Phase 2
222
jondimytpd(dtznawdoyj) = jwymmsjzja snqcppkdzk (jfrxujwqmm )
Positive
24 Jun 2023
jondimytpd(dtznawdoyj) = pkdibcrxbv snqcppkdzk (jfrxujwqmm )
Phase 2
Hypertriglyceridemia
HbA1c | fasting insulin | plasma glucose
-
asoqjfgteh(hsqfbeeaee) = djogrveerr dfytnkcgor (gsmyfdmucb )
Positive
05 Jan 2023
Placebo
asoqjfgteh(hsqfbeeaee) = vzoqtebdgy dfytnkcgor (gsmyfdmucb )
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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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