Global InformationNepidermin information
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| Trade names | Heberprot-P, Easyef, Genesoft, Kang He Su, Regen-D[1] |
| Other names | Recombinant human epidermal growth factor; rhEGF; DWP-401 |
| Routes of administration | intralesional injection; Topical |
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| ECHA InfoCard | 100.241.060 |
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| Formula | C270H401N73O83S7 |
| Molar mass | 6222.03 g·mol−1 |
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Nepidermin (INN proposed),[2] also known as recombinant human epidermal growth factor (rhEGF), is a recombinant form of human epidermal growth factor (EGF) and a cicatrizant (a drug that promotes wound healing through formation of scar tissue). As a recombinant form of EGF, nepidermin is an agonist of the epidermal growth factor receptor (EGFR), and is the first EGFR agonist to be marketed.[3][4] It was developed by Cuban Center for Genetic Engineering and Biotechnology (CIBG), and has been marketed by Heber Biotech as an intralesional injection for diabetic foot ulcer under the trade name Heberprot-P since 2006.[5][6] As of 2016, Heberprot-P had been marketed in 23 countries,[7] but remains unavailable in the United States. In 2015, preparations were made to conduct the Phase III trials required for FDA approval,[8][9] however as of 2023 developments in U.S.-Cuba relations have stymied importation of the drug from Cuba.
Various forms of rhEGF are marketed for the treatment of diabetic foot ulcers, wounds, and alopecia (hair loss) in Vietnam, the Philippines, Thailand, and China.[1][3][4]
- ^ a b Cite error: The named reference
Drugs.comwas invoked but never defined (see the help page). - ^ "INN Proposed List 97". www.who.int.
- ^ a b Cite error: The named reference
AdisInsightwas invoked but never defined (see the help page). - ^ a b Cite error: The named reference
LauKim2016was invoked but never defined (see the help page). - ^ Berlanga J, Fernández JI, López E, López PA, del Río A, Valenzuela C, et al. (January 2013). "Heberprot-P: a novel product for treating advanced diabetic foot ulcer". MEDICC Review. 15 (1): 11–15. doi:10.37757/MR2013V15.N1.4. PMID 23396236.
- ^ Fernández-Montequín JI, Betancourt BY, Leyva-Gonzalez G, Mola EL, Galán-Naranjo K, Ramírez-Navas M, et al. (February 2009). "Intralesional administration of epidermal growth factor-based formulation (Heberprot-P) in chronic diabetic foot ulcer: treatment up to complete wound closure". International Wound Journal. 6 (1): 67–72. doi:10.1111/j.1742-481X.2008.00561.x. PMC 7951202. PMID 19291119.
- ^ "Heberprot-P registered in 23 countries". National Network on Cuba. 10 June 2016. Retrieved 2023-01-16.
- ^ Brenner A (2018-03-22). "U.S. and Cuban companies reach agreement on Heberprot-p". The Cuban Handshake. Retrieved 2023-01-16.
- ^ Clinical trial number NCT02554851 for "Efficacy and Safety Evaluation of the Intralesional Recombinant Human Epidermal Growth Factor (rhEGF) in Subjects With Diabetic Foot Ulcer. Multicenter, Randomized, Double-blind, Placebo-controlled Study." at ClinicalTrials.gov The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)