Nepidermin
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Nepidermin (
INN Inns are generally establishments or buildings where travelers can seek lodging, and usually, food and drink. Inns are typically located in the country or along a highway. Before the advent of motorized transportation, they also provided accomm ...
proposed), also known as recombinant human epidermal growth factor (rhEGF), is a recombinant form of
human Humans (''Homo sapiens'') or modern humans are the most common and widespread species of primate, and the last surviving species of the genus ''Homo''. They are Hominidae, great apes characterized by their Prehistory of nakedness and clothing ...
epidermal growth factor (EGF) and a
cicatrizant D03A Cicatrizants D03AA Cod-liver oil ointments D03AX Other cicatrizants :D03AX01 Cadexomer iodine :D03AX02 Dextranomer :D03AX03 Dexpanthenol :D03AX04 Calcium pantothenate :D03AX05 Hyaluronic acid :D03AX06 Becaplermin :D03AX09 Crilanomer : ...
(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 The epidermal growth factor receptor (EGFR; ErbB-1; HER1 in humans) is a transmembrane protein that is a receptor (biochemistry), receptor for members of the epidermal growth factor family (EGF family) of extracellular protein ligand (biochemistry ...
(EGFR), and is the first EGFR agonist to be marketed. It was developed by
Cuba Cuba, officially the Republic of Cuba, is an island country, comprising the island of Cuba (largest island), Isla de la Juventud, and List of islands of Cuba, 4,195 islands, islets and cays surrounding the main island. It is located where the ...
n
Center for Genetic Engineering and Biotechnology The Center for Genetic Engineering and Biotechnology (, CIGB) is a research institute in Havana, Cuba. Founding In 1982, the United Nations Industrial Development Organization (UNIDO) offered grant funding via a competitive application process ...
(CIBG), and has been marketed by Heber Biotech as an intralesional injection for
diabetic foot ulcer Diabetic foot ulcer is a breakdown of the skin and sometimes deeper tissues of the foot that leads to sore formation. It is thought to occur due to abnormal pressure or mechanical stress chronically applied to the foot, usually with concomitant pre ...
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. Various forms of rhEGF are marketed for the treatment of
diabetic foot ulcer Diabetic foot ulcer is a breakdown of the skin and sometimes deeper tissues of the foot that leads to sore formation. It is thought to occur due to abnormal pressure or mechanical stress chronically applied to the foot, usually with concomitant pre ...
s,
wound A wound is any disruption of or damage to living tissue, such as skin, mucous membranes, or organs. Wounds can either be the sudden result of direct trauma (mechanical, thermal, chemical), or can develop slowly over time due to underlying diseas ...
s, and
alopecia Hair loss, also known as alopecia or baldness, refers to a loss of hair from part of the head or body. Typically at least the head is involved. The severity of hair loss can vary from a small area to the entire body. Inflammation or scarring ...
(hair loss) in
Vietnam Vietnam, officially the Socialist Republic of Vietnam (SRV), is a country at the eastern edge of mainland Southeast Asia, with an area of about and a population of over 100 million, making it the world's List of countries and depende ...
, the
Philippines The Philippines, officially the Republic of the Philippines, is an Archipelagic state, archipelagic country in Southeast Asia. Located in the western Pacific Ocean, it consists of List of islands of the Philippines, 7,641 islands, with a tot ...
,
Thailand Thailand, officially the Kingdom of Thailand and historically known as Siam (the official name until 1939), is a country in Southeast Asia on the Mainland Southeast Asia, Indochinese Peninsula. With a population of almost 66 million, it spa ...
, and
China China, officially the People's Republic of China (PRC), is a country in East Asia. With population of China, a population exceeding 1.4 billion, it is the list of countries by population (United Nations), second-most populous country after ...
.


Production

According to Heber Biotech, nepidermin is made by insering the 53-amino acid human EGF sequence into
yeast Yeasts are eukaryotic, single-celled microorganisms classified as members of the fungus kingdom (biology), kingdom. The first yeast originated hundreds of millions of years ago, and at least 1,500 species are currently recognized. They are est ...
. A 1991 paper from Cuba seems to describe its production in more detail. An improved process was described in 2009.


Other rhEGFs

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. Instead of measuring by mass, the
international unit In pharmacology, the international unit (IU) is a unit of measurement for the effect or biological activity of a substance, for the purpose of easier comparison across similar ''forms'' of substances. International units are used to quantify vi ...
system from the
World Health Organization The World Health Organization (WHO) is a list of specialized agencies of the United Nations, specialized agency of the United Nations which coordinates responses to international public health issues and emergencies. It is headquartered in Gen ...
provides a way to describe the potency-adjusted amount of rhEGF. However, the WHO does not prescribe a specific way of measuring the potency. rhEGF
bioassay A bioassay is an analytical method to determine the potency or effect of a substance by its effect on animal testing, living animals or plants (''in vivo''), or on living cells or tissues (''in vitro''). A bioassay can be either quantal or quantit ...
remains a field in active development.


Other preparations


See also

*
Becaplermin Becaplermin, sold under the brand name Regranex, is a cicatrizant, available as a topical gel. Regranex is a human platelet-derived growth factor indicated along with good wound care for the treatment of lower extremity diabetic neuropathic ...
*
Murodermin Murodermin (INN), also known as recombinant murine epidermal growth factor (rmEGF), is a recombinant form of mouse epidermal growth factor (EGF) and an EGF receptor agonist An agonist is a chemical that activates a Receptor (biochemistry), r ...


References

{{Growth factor receptor modulators Growth factors Hair loss medications Human proteins Recombinant proteins Cuban inventions