Peptides›Cognitive›NGF (Nerve Growth Factor)

NGF (Nerve Growth Factor)

/ Endogenous neurotrophin (beta-subunit homodimer of NGF complex); recombinant

TIER 2 · TranslationalN = 0 · TESTING PENDINGMW 26500.00 g·mol⁻¹

ALIAS · Nerve growth factor · Beta-NGF · Cenegermin (recombinant human NGF — Oxervate) · Oxervate (trade) · rhNGF

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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 · 26500.00CLASS · Endogenous neurotrophin (beta-subunit homodimer of NGF complex); recombinantCATEGORY · Cognitive

Tier 2. Cenegermin (recombinant human NGF, marketed as Oxervate) is FDA-approved (2018) for neurotrophic keratitis based on the REPARO Phase 2 and Phase 3 trials. Vendor research-grade NGF sold by peptide suppliers is not pharmaceutically equivalent to cenegermin and has no human use. Broader NGF investigation in Alzheimer disease (gene-therapy delivery) and peripheral neuropathy did not translate to approved indications.

§ B · Mechanism of action

Nerve growth factor (NGF) is the founding member of the neurotrophin family, discovered by Rita Levi-Montalcini and Stanley Cohen (Nobel Prize 1986). The biologically active form is a homodimer of the beta-subunit (~26 kDa) that signals through the high-affinity TrkA receptor tyrosine kinase and the low-affinity p75 neurotrophin receptor. NGF promotes survival and differentiation of basal forebrain cholinergic neurons, sympathetic neurons, and small-diameter sensory neurons. In the cornea, topical NGF supports trigeminal sensory neuron health and corneal epithelial regeneration, the mechanism underlying the cenegermin neurotrophic-keratitis indication.

§ C · Human clinical evidence

Tier 2. Cenegermin received FDA approval based on the REPARO Phase 2 and confirmatory Phase 3 trials (Bonini and colleagues) in neurotrophic keratitis showing improved corneal healing versus vehicle. Earlier intracerebroventricular and gene-therapy NGF trials in Alzheimer disease (CERE-110 / AAV2-NGF) reached Phase 2 without efficacy advantage. Vendor research-grade NGF protein has only preclinical use and no human clinical evidence.

§ D · Primary literature

PubMed29653858Bonini S et al. — Phase II randomized, double-masked, vehicle-controlled trial of recombinant human nerve growth factor for neurotrophic keratitis · Ophthalmology · human-phase-2Recombinant human NGF eye drops at 20 mcg/mL six times daily for eight weeks were associated with greater corneal healing rates than vehicle in moderate-to-severe neurotrophic keratitis.Limitations: Single Phase 2 trial; outcome was a binary corneal-healing endpoint; sponsor-affiliated steering committee.2018

PubMed31585826Pflugfelder SC et al. — Topical recombinant human nerve growth factor (cenegermin) for neurotrophic keratopathy: a multicenter randomized vehicle-controlled pivotal trial · Ophthalmology · human-phase-3-rctIn a US-based pivotal trial, cenegermin 20 mcg/mL eye drops eight weeks were associated with higher corneal healing rates than vehicle, supporting FDA approval for neurotrophic keratitis.Limitations: Modest sample size; specific neurotrophic-keratitis population; ocular indication only.2020

§ F · Safety signal

Cenegermin in REPARO trials produced ocular pain, conjunctival hyperemia, and eye inflammation as the most common local adverse events; systemic exposure was minimal with topical ocular dosing. Historical systemic NGF trials in peripheral neuropathy were limited by injection-site hyperalgesia from sensory neuron sensitisation, a class effect of administered NGF.

§ H · Regulatory status

Regulatory status

FDA status:: FDA-approved

§ I · Notable gaps and controversies

The most important practical distinction: vendor research-grade 'NGF' protein and the FDA-approved cenegermin (Oxervate) are different products despite both containing recombinant human NGF protein. Cenegermin is manufactured under GMP for ophthalmic dosing in a specific formulation; vendor research-grade material is for in-vitro use, has no purity or sterility guarantees suitable for human exposure, and is not interchangeable. AD-directed NGF programs (gene therapy, cell-based delivery) have not produced positive Phase 3 readouts despite robust preclinical biology.