Fibroblast Growth Factors (FGF)

Modality

FGF-1 (or acidic FGF, aFGF)

FGF-1 (or acidic FGF, aFGF), as an endothelial cell growth factor present extracted from bovine hypothalamic, was first introduced in 1979. The medicinal or physically applied FGF1’s functional repertoire includes angiogenesis, skeletal muscle regeneration, wound healing, and cardioprotection. Recently, FGF1 has attracted attention as an anti-diabetic agent.

FGF-2 (or basic FGF, bFGF)

Basic FGF, an 18 kDa protein, attracts division and mitogenesis of a wide range of neuroectodermal and mesodermal cells such as fibroblasts, smooth muscle cells, and endothelial cells. Due to its mitogenic effect on fibroblasts and chondrocytes, the first isolated bFGF was found in certain hormone preparations and was subsequently purified from the bovine pituitary.

Acidic and basic FGF are angiogenic in vivo and are thought to play a role in embryonic development. Both are single-chain polypeptides with approximately 17 kDa and share 55% amino acid sequence identity.

FGF-7

FGF-7, also known as palifermin or keratinocyte growth factor (KGF), is part of the FGF family. KGF can induce epithelial cell proliferation, differentiation, and migration by binding to its receptor. With a high level of receptor specificity, it performs important roles in maintaining tissue regeneration and mucosal barrier integrity. Researchers developed human recombinant KGF (palifermin) to promote the growth of damaged epithelial tissues.

FGF-19

FGF19 functions in the brain to decrease food intake and increase energy expenditure in addition to controlling lipid and glucose metabolism in the liver. Recombinant FGF-19 is developed for treating biliary cirrhosis and primary sclerosing cholangitis.

FGF-21

FGF-21 is produced primarily in the liver and secreted into the bloodstream because it lacks the canonical heparan binding domains characteristic of other nonendocrine FGF. The identified biological effects of FGF21 include weight loss through decreased food ingestion and increased energy consumption.

To increase the stability of the molecule, FGF21 is engineered by binding it to larger peptides (immunoglobulin fragments) or polyethylene glycols (PEG).

As of today, several clinical trials have been going on to evaluate the potential of FGF21-based therapies in patients with overweight or obesity, diabetes mellitus, and nonalcoholic steatohepatitis (NASH).

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Fibroblast Growth Factors (FGF) Pipelines

Types	Brand Name	Alternative Name	Expression System	Indication	Manufacturer	Stage
FGF-1	Recombinant human acidic fibroblast growth factor	艾夫吉夫, Acidic FGF	Escherichia coli (E. coli)	Wound healing	Shanghai Tenry Pharmaceutical	Approval
FGF-1	Fibroblast growth factor 1	CVBT-141, Acidic FGF, Cardio Vascu-Grow	Pending update	Wound healing	Venturis Therapeutics, Inc.	Phase II
FGF-1	TTHX-1114	NM141	Pending update	Corneal dystrophies	Trefoil Therapeutics, Inc.	Phase II
FGF-1	Human Fibroblast growth factor 1	FGF-1	Pending update	Parkinson's disease	Zhittya Genesis Medicine, Inc.	Phase I
FGF-2	Recombinant human basic fibroblast growth factor	Gaifu, 盖扶	E. coli	Trauma and Injury, Surgical Wounds	Langtide Biopharmaceutical	Approval
FGF-2	Recombinant bovine basic fibroblast growth factor gel	贝复新	E. coli	Trauma and Injury	Zhuhai Essex Bio-Pharmaceutical	Approval
FGF-2	Trafermin	Fiblast Spray, CAB 2001, KCB-1, Regroth, KCB-1D, 曲弗明, リグロス	E. coli	Periodontitis, Pressure Ulcer, Skin Ulcer	Kaken Pharmaceutical Co., Ltd.	Approval
FGF-2	Trafermin biosimilar	Retympa, NPC 18, リティンパ \| リティンパ耳科用250µgセット, Trafermin	Pending update	Tympanic membrane perforation	Translational Research Informatics Center \| Nobelpharma Co., Ltd.	Approval
FGF-2	Recombinant bovine basic fibroblast growth factor	见林	E. coli	Trauma and Injury	Changchun Changsheng Gene Pharmaceutical	Approval
FGF-2	Recombinant basic fibroblast growth facto	扶济复	E. coli	Burn	Beijing SL Pharmaceutical Co., Ltd.	Approval
FGF-2	Recombinant bovine basic fibroblast growth factor for external use	贝复济	E. coli	Burn, Skin Ulcer	Zhuhai Essex Bio-Pharmaceutical	Approval
FGF-2	Recombinant bovine basic fibroblast growth factor	贝复舒	E. coli	Corneal ulcer, Keratitis, Burn	Zhuhai Essex Bio-Pharmaceutical	Approval
FGF-2	Human Fibroblast Growth Factor 2	FGF-2	Pending update	Tympanic membrane perforation	NYU Elaine A. & Kenneth G. Langone Medical Center	Phase II
FGF-2	Recombinant bovine basic fibroblast growth factor	Pending update	Pending update	Stomatitis	Nanchang University	Phase II
FGF-2	Recombinant basic fibroblast growth factor	Pending update	Pending update	Trauma and Injury	China Gene PharmValley	Phase I
FGF-2	Recombinant Human Fibroblast Growth Factor-2	rhFGF-2	Pending update	gum recession	Universidade Federal Fluminense	Phase I
FGF-4	HST-001	Hair stimulating complex, HSC-660, HST 001	Pending update	Hair loss	Histogen, Inc.	Phase II
FGF-7	Palifermin	AMJ 9701, Kepivance	E. coli	Stomatitis	Swedish Orphan Biovitrum AB \| Biovitrum AB	Approval
FGF-7	Palifermin biosimilar	Pending update	Pending update	Mucositis	Chengdu Zhitian Biological Engineering	Phase II
FGF-7	Recombinant Human Keratinocyte Growth Factor	Pending update	Pending update	Pending	Jiangsu Aosaikang Pharmaceutical	Phase I
FGF-19	Aldafermin	NGM-282, M-70, M52, recombinant human FGF-19 variant	E. coli	Fibrosis, Nonalcoholic steatohepatitis, Type 2 diabetes	NGM Biopharmaceuticals, Inc.	Phase II
FGF-21	Pegbelfermin	BMS 986036, ARX-618, PEG-FGF21, Pegylated FGF21, FGF-21 mimetic proteins	Pending update	Cirrhosis, Liver disease, Fibrosis, Nonalcoholic steatohepatitis, Type 2 diabetes	Bristol Myers Squibb Co., Ambrx, Inc.	Phase II
FGF-21	Efruxifermin	AKR-001, AMG-876, Fc-FGF21(RGE), EFX	Pending update	Cirrhosis, Nonalcoholic Steatohepatitis, Type 2 Diabetes	Akero Therapeutics, Inc.	Phase II
FGF-21	Fazpilodemab	BFKB 8488A, RG 7992, RO 7040551	Pending update	Non-Alcoholic Steatohepatitis, Disease	Genentech, Inc.	Phase II
FGF-21	BOS-580	BOS 580, BOS-580-201, LLF 580, LLF-580	Pending update	Nonalcoholic Steatohepatitis, Obesity	Boston Pharmaceuticals, Inc.	Phase II
FGF-21	NN-9499	NN9499, NNC 0194 0499	Pending update	Metabolism and Nutrition Disorder, \|Obesity	Novo Nordisk A/S	Phase II
FGF-21	Pegozafermin	BIO89 100, TEV 47948	Pending update	Severe Hypertriglyceridemia NASH, Nonalcoholic Steatohepatitis	89bio, Inc.	Phase II
FGF-21	NGM-313	MK 3655	Pending update	Nonalcoholic steatohepatitis, Hepatitis, Obesity	Merck Sharp & Dohme Corp., Merck GmbH, Merck & Co., Inc., NGM Biopharmaceuticals, Inc., Werthenstein BioPharma GmbH	Phase II
FGF-21	Recombinant pegylated human FGF21	B1344, PEG recombinant human FGF21	Pending update	Type 2 diabetes, Nonalcoholic Steatohepatitis	Tasly Biopharmaceuticals Co., Ltd.	Phase I
FGF-21	DR10624	DR 10624	Pending update	Obese, Metabolic Syndrome, Type 2 Diabetes	Zhejiang Doer Biologics Co., Ltd \|Huadong Medicine Co.,Ltd	Phase I
FGF-21	HEC-88473	HEC 88473	Pending update	Obese, Type 2 Diabetes, Non-alcoholic Fatty Liver Disease, Fatty Liver, Liver Diseases, Digestive System Diseases	Dongguan HEC Biopharmaceutical R&D Co., Ltd., Dongguan HEC TaiGen Biopharmaceuticals Co., Ltd.	Phase I
FGF-21	AP-026	AP 026	Pending update	Type 2 diabetes, Nonalcoholic Steatohepatitis	Ampsource Biopharma Shanghai Inc., Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	Phase I
FGF-21	Recombinant FGF21-Fc fusion Protein	AP-025, long-acting FGF-21 analog	Pending update	Nonalcoholic Steatohepatitis	Ampsource Biopharma Shanghai Inc., Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	Phase I
FGF-21	LY-3025876	Pending update	Pending update	Type 2 Diabetes	Eli Lilly & Co.	Phase I

Reference:

[1] Gasser E, Sancar G, Downes M, Evans RM. Metabolic Messengers: fibroblast growth factor 1. Nat Metab. 2022 Jun;4(6):663-671. doi: 10.1038/s42255-022-00580-2.

[2] Geng L, Lam KSL, Xu A. The therapeutic potential of FGF21 in metabolic diseases: from bench to clinic. Nat Rev Endocrinol. 2020 Nov;16(11):654-667. doi: 10.1038/s41574-020-0386-0.

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Fibroblast Growth Factors (FGF)

Modality