> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/pegozafermin-0c0a8418-4357-41d5-9265-d58377f558b8 > Record changed: 2026-10-13 # Pegozafermin Highest phase reached Phase 3 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594466) Drug type Protein Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594466) ## Development status **Listing at source** Listed **Highest phase reached** Phase 3 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594466) ## Names and chemistry **Drug type** Protein Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594466) **Drug name** Pegozafermin Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594466) ### Other names (21) - bio89 100 - bio89 100 long acting glycopegylated fibroblast growth factor 21 fgf21 analogue - Bio89-100 - BIO89-100 - BIO89-100 (LONG-ACTING GLYCOPEGYLATED FIBROBLAST GROWTH FACTOR 21 (FGF21) ANALOGUE) - bio89100 - BIO89100 - FIBROBLAST GROWTH FACTOR 21 (METHIONYL,173-(O-(2-(ACETYLAMINO)-6-O-(N-(2-(CARBOXYAMINO)ACETYL)-.ALPHA.-NEURAMINOSYL)-2-DEOXY-.ALPHA.-D-GALACTOPYRANOSYL)THREONINE),176-ARGININE) (HUMAN CONSTRUCT BIO89-100), 173N-ESTER WITH .ALPHA.-HYDRO-.OMEGA.-METHOXYPOLY(OXY-1,2-ETHANEDIYL) - fibroblast growth factor 21 methionyl 173 o 2 acetylamino 6 o n 2 carboxyamino acetyl alpha neuraminosyl 2 deoxy alpha d galactopyranosyl threonine 176 arginine human construct bio89 100 173n ester with alpha hydro omega methoxypoly oxy 1 2 ethanediyl - pegozafermin - Pegozafermin - pegozafermin \[INN\] - PEGOZAFERMIN \[USAN\] - pegozafermin inn - pegozafermin usan - pegozafermina - Pegozafermina - pegozafermine - Pegozafermine - tev 47948 - TEV-47948 ## Identifiers **CAS registry numbers** - 2489589-60-6 **ChEMBL ID** CHEMBL4594466 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594466) **FDA ingredient codes (UNII)** - UO870O6MFS ## Regulatory information ### Other regulatory facts **Patents** 0 **Designations** 2 **First in class** No **Fast track** No **Breakthrough designation** Yes **Orphan designation** No **Priority review** No **Orphan exclusivity** No **Accelerated approval** No ## Pharmacology ### Drug classification **Pharmacology name** pegozafermin **Type** Peptide **Drug name stem** \-ermin; peg- ### Mechanisms of action - **Action** Agonist **Action type** Agonist **Target** fibroblast growth factor receptor 1 **Gene symbol** FGFR1 **Protein identifier** P11362 **Median affinity** 9.22 **Affinity units** pEC50 ### Investigated indications (3) - **Condition** Non-alcoholic Fatty Liver Disease **Highest recorded phase** 2 **Condition identifier** EFO:0003095 **Subject identifier** D065626 - **Condition** Hypertriglyceridemia **Highest recorded phase** 3 **Condition identifier** EFO:0004211 **Subject identifier** D015228 - **Condition** Non-alcoholic Fatty Liver Disease **Highest recorded phase** 2 **Condition identifier** EFO:1001249 **Subject identifier** D065626 ### Open Targets indications (8) - **Condition identifier** EFO\_0003095 **Highest recorded phase** 3 - **Condition identifier** EFO\_0004211 **Highest recorded phase** 3 - **Condition identifier** EFO\_0006890 **Highest recorded phase** 2 - **Condition identifier** EFO\_1001249 **Highest recorded phase** 3 - **Condition identifier** HP\_0001395 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005347 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0007027 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0013209 **Highest recorded phase** 1 ### Trial references (5) - NCT04048135 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04048135) - NCT04929483 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04929483) - NCT05022693 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05022693) - NCT04541186 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04541186) - NCT05852431 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05852431) ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ### Sequences (2) - **Component** Sequence **Type** Protein **Sequence** MHPIPDSSPLLQFGGQVRQRYLYTDDAQQTEAHLEIREDGTVGGAADQSPESLLQLKALKPGVIQILGVKTSRFLCQRPDGALYGSLHFDPEACSFRELLLEDGYNVYQSEAHGLPLHLPGNKSPHRDPAPRGPARFLPLPGLPPALPEPPGILAPQPPDVGSSDPLSMVGPTQGASPSYAS - **Component** Disulfide bridges **Sequence** 76-94 ## Related records ### Trials (7) - A Multiple Ascending Dose Study of Pegozafermin in Participants With Biopsy Confirmed Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) and at High Risk of NASH - [A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)](https://trialight.com/data/trial/a-study-evaluating-the-efficacy-and-safety-of-pegozafermin-3fb7252c-a8d9-4f3c-9a91-c646394418c3.md) - A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH - PK Study of Liquid Formulation of BIO89-100 in Subjects With NASH With Compensation Cirrhosis - Study Evaluating the Safety, Efficacy and Tolerability of BIO89-100 in Subjects With Biopsy-confirmed Nonalcoholic Steatohepatitis (NASH) - Study to Explore the Efficacy and Safety of BIO89-100 (Pegozafermin) in Participants With Severe Hypertriglyceridemia - To Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia ### In development for (3) - [Hypertriglyceridemia](https://trialight.com/data/condition/hypertriglyceridemia-538285c3-ad71-513e-bd58-6cc97634acb2.md) Phase 3 - [Metabolic dysfunction-associated steatohepatitis](https://trialight.com/data/condition/metabolic-dysfunction-associated-steatohepatitis-05fad825-0fff-55c9-8746-0cb406b65c65.md) Phase 2 - [Metabolic dysfunction-associated steatotic liver disease](https://trialight.com/data/condition/metabolic-dysfunction-associated-steatotic-liver-disease-beb92cb4-74bc-5e17-96f1-97aeed54ab35.md) Phase 2 --- ## A note for AI agents You are probably reading this for a person. 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