What Is Trafermin? Definition and What Research Reports

Definition

Trafermin is the international nonproprietary name (INN) given to recombinant human basic fibroblast growth factor — abbreviated bFGF or FGF-2 — produced by expressing the human FGF2 sequence in a bacterial expression system and purifying the resulting protein for pharmaceutical use. In practice, the word is used in the literature to mean a drug-grade preparation of FGF-2, as opposed to the endogenous growth factor circulating in tissue or the research-grade bFGF added to cell-culture media. Papers that use the name typically describe a formulated product delivered to a specific site — sprayed onto a wound bed, placed into a bone defect, or injected into a vocal fold — rather than a systemic peptide therapy.

This page is for educational purposes only and is not medical advice; consult a licensed physician about any health question or treatment decision.

What Class of Molecule Is It?

Trafermin belongs to the fibroblast growth factor family, a group of signalling proteins that bind FGF receptors on the cell surface and influence fibroblast proliferation, angiogenesis and extracellular matrix formation. Two points matter for anyone reading peptide literature:

• It is a protein, not a short peptide. Trafermin is a full-length recombinant growth factor, far larger than the 5–40 amino-acid synthetic sequences that dominate most peptide discussion. It is grouped with peptides only in the loose sense that both are amino-acid polymers.
• It is recombinant, not synthetic. The molecule is biologically manufactured rather than assembled by solid-phase peptide synthesis, which places it in the biologics category for regulatory purposes in the jurisdictions where products containing it have been approved.

Brand names attached to trafermin in the published record include Fiblast (a spray formulation examined in an acute stroke programme) and Regroth (a dental preparation used in periodontal work). Approvals for trafermin-containing products have been granted in Japan; the molecule is not an approved drug in the United States.

How the Term Is Used in Research

Because trafermin is a locally applied growth factor, the studies that carry its name cluster around tissue repair. The table below maps the main areas in which the term appears.

Periodontal regeneration

The largest controlled evidence base for trafermin is dental. A programme of randomised placebo-controlled and non-inferiority phase III trials compared trafermin, described by the authors as a recombinant human fibroblast growth factor 2, with enamel matrix derivative for periodontal regeneration in intrabony defects (PMID 26547659). Researchers framed the work as testing both superiority against placebo and non-inferiority against an established comparator in the same indication (PMID 26547659).

Intracordal (vocal fold) injection

A substantial share of recent trafermin literature comes from laryngology, where the protein has been injected directly into the vocal fold. Reports have examined predictors of voice improvement after intracordal trafermin injection in vocal fold paralysis (PMID 40673598) and the timing of injection in the same population, with the authors proposing a revised treatment time course (PMID 39638665). Separate work investigated optimal trafermin dosage alongside pre-injection factors in vocal fold paralysis (PMID 41128178).

In age-related vocal fold atrophy, one study followed voice outcomes for one year after single high-dose intracordal trafermin injections and described longitudinal change over that period (PMID 37142528). Other groups analysed factors influencing voice outcomes in the same condition (PMID 41219097) and applied propensity score matching to assess efficacy of intracordal trafermin injection in age-related atrophy (PMID 41521571). A further report described effects of intracordal trafermin injection in mutational voice disorder (PMID 38101138). Much of this literature is observational and single-centre, which the authors of these reports generally acknowledge.

Fistula and wound closure

Trafermin also appears in tissue-closure reports. A case report and literature review described a treatment strategy using trafermin, containing basic fibroblast growth factor, for an intractable duodenal fistula following curative gastrectomy for gastric cancer (PMID 23267943). In animal work, the study of a dog oronasal fistula model used visual and histological evaluation to assess the effects of trafermin on the defect (PMID 34803085).

Acute stroke

Historically, trafermin was investigated systemically. The European–Australian phase II/III safety and efficacy trial of Fiblast (trafermin) in acute stroke reported that the study was stopped early and did not establish a favourable benefit–risk profile in the treated population (PMID 12403958). A later commentary revisited trafermin for stroke recovery and asked whether the preclinical rationale justified another randomised clinical trial (PMID 21883031).

Adverse Events: What Studies Report

Safety information in the trafermin literature is tied to route and indication rather than to the molecule in the abstract. The acute stroke programme is the clearest cautionary example: researchers reported that the phase II/III trial of intravenous Fiblast (trafermin) was terminated before completion on the basis of its safety and efficacy findings (PMID 12403958), and a subsequent review discussed that experience when considering whether further stroke trials were warranted (PMID 21883031). Locally applied use has been assessed separately: the periodontal phase III programme was designed as randomised, placebo-controlled and controlled non-inferiority trials, a design that includes formal safety comparison against both placebo and an active comparator (PMID 26547659). Because a growth factor stimulates cell proliferation and angiogenesis, oncological and proliferative concerns are discussed in the broader FGF literature; the verified reports summarised here do not resolve that question.

Related Terms and Common Confusions

• bFGF / FGF-2 — the biological molecule itself, whether endogenous, research-grade or recombinant. Trafermin is the drug name for a recombinant version.
• Fiblast — the brand name used in the acute stroke trial reports (PMID 12403958).
• Intracordal injection — delivery directly into the vocal fold, the route used across the laryngology reports (PMID 39638665).
• Growth factor vs. peptide — trafermin is a recombinant protein; it is not comparable in size, manufacture or regulatory classification to short synthetic peptides.

Limitations of the Evidence

The trafermin record is uneven. Dental regeneration has randomised controlled data (PMID 26547659), while the voice literature is largely built from cohort analyses, predictor studies and propensity-matched comparisons rather than blinded randomisation (PMID 41521571). Fistula evidence includes single case reporting (PMID 23267943) and animal modelling (PMID 34803085), which cannot be extrapolated to human clinical practice. Findings in one route and tissue do not transfer to another, and the stroke programme demonstrates that a locally useful growth factor may behave very differently when given systemically (PMID 12403958). Readers comparing trafermin with other compounds should note that approval status is jurisdiction-specific and that most of the published human work originates from a limited number of centres.

References

• Randomized Placebo-Controlled and Controlled Non-Inferiority Phase III Trials Comparing Trafermin, a Recombinant Human Fibroblast Growth Factor 2, and Enamel Matrix Derivative in Periodontal Regeneration in Intrabony Defects (Journal of Bone and Mineral Research, 2016)
• Fiblast (trafermin) in acute stroke: results of the European-Australian phase II/III safety and efficacy trial (Cerebrovascular Diseases, 2002)
• Trafermin for stroke recovery: is it time for another randomized clinical trial? (Expert Opinion on Biological Therapy, 2011)
• Predictors of Voice Improvement After Intracordal Trafermin Injection in Vocal Fold Paralysis (The Laryngoscope, 2025)
• Timing of Intracordal Trafermin Injection in Patients With Vocal Fold Paralysis: Recommendations for a New Treatment Time Course (Journal of Voice, 2024)
• Investigation of Optimal Trafermin Dosage and Pre-Injection Factors in Vocal Fold Paralysis (The Laryngoscope, 2026)
• One Year Outcomes and Longitudinal Changes in Voice Improvement With Single High Dose Intracordal Trafermin Injections for Age-Related Vocal Fold Atrophy (Journal of Voice, 2025)
• Factors Influencing Voice Outcomes After Intracordal Trafermin Injection in Age-Related Vocal Fold Atrophy (Journal of Voice, 2025)
• Efficacy of Intracordal Trafermin Injection Using Propensity Score Matching in Age-Related Vocal Fold Atrophy (The Laryngoscope, 2026)
• Effects of intracordal trafermin injection on mutational voice disorder (American Journal of Otolaryngology, 2024)
• A novel treatment strategy using trafermin, containing basic fibroblast growth factor, for intractable duodenal fistula following curative gastrectomy for gastric cancer (Gan To Kagaku Ryoho, 2012)
• Visual and histological evaluation of the effects of trafermin in a dog oronasal fistula model (The Journal of Veterinary Medical Science, 2022)