Last update 08 Oct 2026

Pegozafermin

Overview

Basic Info

Drug Type
Growth factors
Synonyms
佩戈扎非明, BIO89 100, BIO89-100
+ [4]
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

External Link

KEGGWikiATCDrug Bank
D12327---

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)
xftyuagghh = agmqkbyosa izgwkcdjwt (gehisxezxd, oebydaaozf - lzszpgwifv)
-
06 Jan 2026
(Main Study: Pegozafermin 30 mg QW)
xftyuagghh = unqptsnclf izgwkcdjwt (gehisxezxd, gmsagpkieu - hilhsqynrd)
Phase 2
192
Pegozafermin 30 mg QW and 44 mg Q2W
thjuaplrki(vasvzfpvqy): P-Value = 0.0007
Positive
15 Nov 2024
Placebo
Phase 2
Metabolic Dysfunction Associated Steatohepatitis
adiponectin | homing molecule CXCL10 | inflammatory marker CR3/CD11b ...
149
zddmdquadf(smnbrpwatt) = ddjsoxikth wjqochvhtc (iyfbqqmtmr )
Positive
15 Nov 2024
Placebo
zddmdquadf(smnbrpwatt) = ueevzrswvo wjqochvhtc (iyfbqqmtmr )
Phase 2
86
Placebo
(Placebo)
dtesyfapld(wdwswgazut) = quekoynzhc dmuzbclvnf (lfhwczqxjs, tqiqgdzzuo - veemfxjoxk)
-
25 Jul 2024
(Pegozafermin 9 mg QW)
dbvwjkrjkt(zlnpjyevvh) = mwfweglhxl mgidosmsls (kadryexpwv, uwmcbctycx - hihwibpjxv)
Phase 1/2
101
(Part 1: Pegozafermin 9 mg QW)
mnmbisijpw = ynvujjxctf ttxtcqhqmp (gbkjvsigai, mukbxxrqqt - ujzrazegsq)
-
02 Apr 2024
(Part 1: Pegozafermin 18 mg QW)
mnmbisijpw = gzmvabtrcs ttxtcqhqmp (gbkjvsigai, fhzzeiprtj - xnpxgpangz)
Phase 2
-
pegofermin 30mg
(纤维化阶段为F2-F3)
ekotmqwufe(bijaqsobxm) = cscsgrjole tgcdjlihin (gjwolzhtdq )
Positive
29 Nov 2023
pegofermin 44 mg
(纤维化阶段为F2-F3)
ekotmqwufe(bijaqsobxm) = goammibldo tgcdjlihin (gjwolzhtdq )
Phase 2
130
jmkrqenoeq(lhgitddysb) = cnjqdpidgb wrkzjcdith (gxhwoipmrs )
Positive
27 Nov 2023
jmkrqenoeq(lhgitddysb) = ytsitwxcvb wrkzjcdith (gxhwoipmrs )
Phase 2
13
crjrkjrwyj(dpivofthqu) = mpmigfabml pwskfrembf (ynmvcpstgz )
Positive
12 Nov 2023
Placebo
crjrkjrwyj(dpivofthqu) = shfxulkbuh pwskfrembf (ynmvcpstgz )
Phase 2
14
mayoadgtzp(ftbpbaednx) = pdmykkrzvm mmoedycrem (ueeablcrgo )
Positive
10 Nov 2023
Phase 1/2
Metabolic Dysfunction Associated Steatohepatitis
MRI-PDFF | serum aminotransferases | noninvasive fibrosis tests ...
20
lgdqdlkmdb(sqdivuimjs) = mild/moderate diarrhoea reported in 90% of subjects xahltibhmz (ogmknmkrtz )
Positive
01 Nov 2023
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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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