|Trade names||Easyef, Genesoft, Kang He Su, Regen-D, Heberprot-P|
|Other names||Recombinant human epidermal growth factor; rhEGF; DWP-401|
|CompTox Dashboard (EPA)|
|Chemical and physical data|
|Molar mass||6222.03 g·mol−1|
|3D model (JSmol)|
Nepidermin, 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. 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. As of 2016, Heberprot‐P had been marketed in 23 countries, but remains unavailable in the United States. In 2015, preparations were made to conduct the Phase III trials required for FDA approval, however as of 2023 developments in U.S.-Cuba relations have stymied importation of the drug from Cuba.
A topical spray formulation has been developed under the brand Easyef by Daewoong Pharmaceutical. It is marketed as an ointment for the treatment of diabetic foot ulcers, wounds, and alopecia (hair loss) in Vietnam, the Philippines, Thailand, and China. A Daewoong-funded Phase II study evaluating nepidermin oral spray for chemotherapy-induced oral mucositis did not reduce incidence or duration of moderate or severe oral mucositis, however per-protocol analysis suggested nepidermin oral spray might reduce pain associated with oral mucositis.
- "Nepidermin". Drugs.com. Archived from the original on 2017-12-13. Retrieved 3 June 2017.
- "Nepidermin". AdisInsight. Springer Nature Switzerland AG. Retrieved 3 June 2017.
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- 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. 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)
- Kim JW, Kim MG, Lee HJ, Koh Y, Kwon JH, Kim I, et al. (2017-01-03). "Topical Recombinant Human Epidermal Growth Factor for Oral Mucositis Induced by Intensive Chemotherapy with Hematopoietic Stem Cell Transplantation: Final Analysis of a Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial". PLOS ONE. 12 (1): e0168854. Bibcode:2017PLoSO..1268854K. doi:10.1371/journal.pone.0168854. PMC 5207736. PMID 28045958.