Chemistry:Nepidermin

From HandWiki
Short description: Chemical compound
Nepidermin
Clinical data
Trade namesEasyef, Genesoft, Kang He Su, Regen-D, Heberprot-P[1]
Other namesRecombinant human epidermal growth factor; rhEGF; DWP-401
Routes of
administration
Topical
Identifiers
CAS Number
PubChem CID
ChemSpider
UNII
Chemical and physical data
FormulaC270H401N73O83S7
Molar mass6222.03 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.[2][3] 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.[4][5] As of 2016, Heberprot‐P had been marketed in 23 countries,[6] but remains unavailable in the United States. In 2015, preparations were made to conduct the Phase III trials required for FDA approval,[7][8] 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.[1][2][3] 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 .[1][2][3] 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.[9]

See also

References

  1. 1.0 1.1 1.2 "Nepidermin". Drugs.com. https://www.drugs.com/international/nepidermin.html. 
  2. 2.0 2.1 2.2 "Nepidermin" (in en). AdisInsight. Springer Nature Switzerland AG. http://adisinsight.springer.com/drugs/800016134. 
  3. 3.0 3.1 3.2 "Transcriptional profiling of lung cell populations in idiopathic pulmonary arterial hypertension". Pulmonary Circulation 10 (1): 403–423. 2016. doi:10.1007/s40005-016-0268-6. PMID 32166015. 
  4. "Heberprot-P: a novel product for treating advanced diabetic foot ulcer". MEDICC Review 15 (1): 11–15. January 2013. doi:10.37757/MR2013V15.N1.4. PMID 23396236. 
  5. "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. February 2009. doi:10.1111/j.1742-481X.2008.00561.x. PMID 19291119. 
  6. "Heberprot-P registered in 23 countries". National Network on Cuba. 10 June 2016. https://nnoc.org/heberprot-p-registered-in-23-countries/. 
  7. "U.S. and Cuban companies reach agreement on Heberprot-p". The Cuban Handshake. 2018-03-22. https://www.thecubanhandshake.org/u-s-and-cuban-companies-reach-agreement-on-heberprot-p/. 
  8. 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)
  9. "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. 2017-01-03. doi:10.1371/journal.pone.0168854. PMID 28045958. Bibcode2017PLoSO..1268854K.