Peptides›Cosmetic, Healing›FGF-2 (Basic Fibroblast Growth Factor)

FGF-2 (Basic Fibroblast Growth Factor)

/ Recombinant basic fibroblast growth factor; FGFR1c agonist (and FGFR2/3/4 binding)

TIER 2 · TranslationalN = 0 · TESTING PENDINGMW 17200.00 g·mol⁻¹

ALIAS · Trafermin (trade — Japan) · Fiblast (trade — Japan) · Recombinant bFGF · FGF-2 · Basic FGF

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Research use onlyAny dose figures below describe what specific cited studies used, reported factually. Nothing on this page is guidance for human use.READ FIRST →

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§ A · Identity

Primary sequence— sequence not captured —

MW · 17200.00CLASS · Recombinant basic fibroblast growth factor; FGFR1c agonist (and FGFR2/3/4 binding)CATEGORY · Cosmetic, Healing

Tier 2. Recombinant human FGF-2 (trafermin / Fiblast Spray) is approved in Japan for decubitus ulcers, burns, and skin ulcers (since 2001). Not FDA-approved in the United States. Phase 3 trials in Japan supported the approval; vendor research-grade FGF-2 protein is preclinical material and not equivalent to the approved trafermin formulation.

§ B · Mechanism of action

Basic fibroblast growth factor (FGF-2 / bFGF) is a heparin-binding protein of approximately 18 kDa (155 residues in the predominant secreted isoform) that signals through the FGFR family of receptor tyrosine kinases (FGFR1 through FGFR4) with preference for the FGFR1c isoform, requiring heparan sulfate as an obligate co-receptor. FGFR activation drives Ras-MAPK, PI3K-Akt, and PLC-gamma signalling, promoting fibroblast proliferation, angiogenesis, granulation tissue formation, and re-epithelialisation in wound healing. In dermal pharmacology FGF-2 supplementation is hypothesised to accelerate wound bed maturation through coordinated mitogenic and angiogenic effects.

§ C · Human clinical evidence

Tier 2. The Japanese Phase 3 program for trafermin in pressure ulcers and burns supported the 2001 approval (Akita 2008 and earlier reports). Robson 1992 was an early Phase 1/2 in pressure ulcers reporting wound bed improvement with topical FGF-2. Western development for chronic wounds did not produce an FDA approval; oncological theoretical concerns (FGFR signalling is dysregulated in several cancers) and inconsistent Western trial replication contributed.

§ D · Primary literature

PubMed19128258Akita S et al. — Basic fibroblast growth factor accelerates and improves second-degree burn wound healing · Wound Repair and Regeneration · human-phase-2Topical recombinant FGF-2 (trafermin) accelerated re-epithelialisation and improved scar quality versus standard care in second-degree burn wounds in a Japanese clinical study.Limitations: Modest sample size; single-centre; surrogate endpoints; Japanese approved-product setting.2008

PubMed1417189Robson MC et al. — The safety and effect of topically applied recombinant basic fibroblast growth factor on the healing of chronic pressure sores · Annals of Surgery · human-phase-2Topical recombinant bFGF was generally well tolerated and was associated with greater pressure-sore healing than placebo over the study period in this early Phase 1/2 trial.Limitations: Modest sample size; surrogate wound-closure endpoint; pre-modern Western chronic-wound trial design.1992

§ F · Safety signal

Topical trafermin in Japanese clinical use has produced contact dermatitis, pruritus, and granuloma formation in some recipients; systemic adverse events have been rare with topical dosing. Theoretical concerns about FGFR-driven proliferation in occult malignancy at the wound site have led to labelled cautions but no observed clinical oncology signal in published follow-up. Heparin co-binding requirement means that activity in vivo depends on local heparan sulfate availability.

§ H · Regulatory status

Regulatory status

FDA status:: Not FDA-approved
Compounding:: Compounding eligibility ambiguous

§ I · Notable gaps and controversies

As with EGF, the most important practical distinction is between the Japanese approved formulation (Fiblast Spray, manufactured under pharmaceutical GMP) and vendor research-grade recombinant FGF-2 protein sold by peptide suppliers, which has no human pharmaceutical specification. Western chronic-wound replication has been inconsistent. Theoretical FGFR oncology concerns persist as a regulatory backdrop. Cosmetic-marketing claims for topical FGF-2 in serums or after-procedure skincare exceed the Japanese-approved indications by a wide margin and are not supported by controlled trials of the cosmetic products.