| Clinical data | |
|---|---|
| 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 |
| Identifiers | |
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| CAS Number | |
| PubChemCID | |
| ChemSpider | |
| UNII | |
| CompTox Dashboard(EPA) | |
| ECHA InfoCard | 100.241.060 |
| Chemical and physical data | |
| Formula | C270H401N73O83S7 |
| Molar mass | 6222.03 g·mol−1 |
| 3D model (JSmol) | |
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Nepidermin (INN proposed),[2] also known asrecombinant human epidermal growth factor (rhEGF), is arecombinant form ofhumanepidermal growth factor (EGF) and acicatrizant (a drug that promotes wound healing through formation of scar tissue). As a recombinant form of EGF, nepidermin is an agonist of theepidermal growth factor receptor (EGFR), and is the first EGFR agonist to be marketed.[3][4] It was developed byCubanCenter for Genetic Engineering and Biotechnology (CIBG), and has been marketed byHeber Biotech as an intralesional injection fordiabetic foot ulcer under the trade nameHeberprot-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 2023developments in U.S.-Cuba relations have stymied importation of the drug from Cuba.
Various forms of rhEGF are marketed for the treatment ofdiabetic foot ulcers,wounds, andalopecia (hair loss) inVietnam, thePhilippines,Thailand, andChina.[1][3][4]
According to Heber Biotech, nepidermin is made by insering the 53-amino acid human EGF sequence intoyeast.[10] A 1991 paper from Cuba seems to describe its production in more detail.[11] An improved process was described in 2009.[12]
Several other products containing recombinant human EGF have been marketed. The potencies of these products can differ by the expression system used, despite all intending to match the structure of human EGF.[13]
Instead of measuring by mass, theinternational unit system from theWorld Health Organization provides a way to describe the potency-adjusted amount of rhEGF.[14][15] However, the WHO does not prescribe a specific way of measuring the potency. rhEGFbioassay remains a field in active development.[16]
 | This sectionis missing information about approval status, specifically for this one. Please expand the section to include this information. Further details may exist on thetalk page.(December 2023) |
A topical spray formulation has been developed under the brandEasyef byDaewoong Pharmaceutical.[1][3][4]
ADaewoong-funded Phase II study evaluating nepidermin oral spray forchemotherapy-induced oralmucositis did not reduce incidence or duration of moderate or severe oral mucositis, howeverper-protocol analysis suggested nepidermin oral spray might reduce pain associated with oral mucositis.[17]
Easyef is made by expression inE. coli. It appears to be less potent than an equivalent concentration of Heberprot in zebrafish.[13]
| Brand name | Manufacturer | Form | Indication | Description |
|---|---|---|---|---|
| Heberprot-P | Heber (Cuba) | Lyophilized powder | Ulcer | See above. Drugs.com reports marketing in Vietnam and Georgia.[1] |
| Easyef | Daewoong (Korea) | Spray | Ulcer, wounds | See above. Drugs.com reports marketing in Thailand and Vietnam.[1] |
| Genesoft (金因舒)[18] | Uni-Bio (Hong Kong); Licensed to GeneTech (China) | Eye drop | Corneal damage (?) | Approved in China (Rx, 国药准字 S20040006). Yeast expression system.[19] |
| GeneTime (金因肽) | Spray | Approved in China (Rx, 国药准字 S20010037–8).E. coli expression system.[20] | ||
| Kang He Su (康合素)[21] | Haohai (China) | Lyophilized powder | second-degree burns, wounds, ulcers | Approved in China (Rx, 国药准字 S20010094–6, S20010099). To be used as a part of wound dressing, soaked in gauze.E. coli expression system.[22] |
| Yi Fu (易孚)[23] | Gel | second-degree burns, wounds, ulcers | Approved in China (Rx). Yeast expression system.[24] | |
| Regen-D[25] | Bharat Biotech (India) | Gel | Diabetic foot ulcer | Approved in India and Thailand.[1]E. coli expression system.[26] Bharat also markets a gel withsilver sulfadiazine andchlorhexidine for burns.[27] |