Carcinogenicity assessment of tegoprazan in Sprague-Dawley (Crl:CD) rats and ICR (Crl:CD1) mice.

Kim, M ; Kim, B ; et al.

In: Regulatory toxicology and pharmacology : RTP, Jg. 142 (2023-08-01), S. 105424

academicJournal

Tegoprazan is a novel potassium-competitive acid blocker (P-CAB) that reversibly inhibits the proton pump in gastric parietal cells and has been approved for the treatment of acid-related diseases in Korea. This study aimed to evaluate the carcinogenic potential of tegoprazan in Sprague-Dawley rats and CD-1 mice. Tegoprazan was administered daily by oral gavage to rats for up to 94 weeks and mice for up to 104 weeks. Evidence of carcinogenic potential of tegoprazan was identified in rats only and was limited to benign and/or malignant neuroendocrine cell tumors at exposures >7-fold of the recommended human dose. Glandular stomach findings were considered secondary to the expected pharmacology of tegoprazan, characterized by their location in the fundic and body regions of the stomach. Overall, tegoprazan induced gastric enterochromaffin-like (ECL) cell tumors in SD rats, but did not produce any treatment-related statistically significant increase in the incidence of neoplasms relevant to humans when administered to SD rats and CD-1 mice by gavage at doses up to 300 and 150 mg/kg/day, respectively. Gastric ECL cell tumors are thought to be induced by the exaggerated indirect pharmacological effect of tegoprazan, similar to that reported for proton pump inhibitors (PPIs) and other P-CABs.

Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:Dr. Myeongjoong Kim, Dr. Bongtae Kim, Dr. Ju-Hyun Lee, Mr. Donghyun Kim and Dr. Geun Seog Song are employed by HK inno.N Corporation.

Titel:	Carcinogenicity assessment of tegoprazan in Sprague-Dawley (Crl:CD) rats and ICR (Crl:CD1) mice.
Autor/in / Beteiligte Person:	Kim, M ; Kim, B ; Lee, JH ; Kim, D ; Song, GS ; Williams, SD ; Son, WC
Zeitschrift:	Regulatory toxicology and pharmacology : RTP, Jg. 142 (2023-08-01), S. 105424
Veröffentlichung:	<2003>- : Amsterdam : Elsevier ; <i>Original Publication</i>: New York : Academic Press, [c1981-, 2023
Medientyp:	academicJournal
ISSN:	1096-0295 (electronic)
DOI:	10.1016/j.yrtph.2023.105424
Schlagwort:	Rats Mice Humans Animals Rats, Sprague-Dawley Mice, Inbred ICR Carcinogens toxicity Imidazoles Stomach Neoplasms chemically induced
Sonstiges:	Nachgewiesen in: MEDLINE Sprachen: English Publication Type: Journal Article Language: English [Regul Toxicol Pharmacol] 2023 Aug; Vol. 142, pp. 105424. <i>Date of Electronic Publication: </i>2023 Jun 07. MeSH Terms: Imidazoles* ; Stomach Neoplasms* / chemically induced ; Rats ; Mice ; Humans ; Animals ; Rats, Sprague-Dawley ; Mice, Inbred ICR ; Carcinogens / toxicity Contributed Indexing: Keywords: Carcinogenicity; Mouse; P-CAB; Potassium-competitive acid blocker; Rat; Tegoprazan Substance Nomenclature: W017G7IF4S (tegoprazan) ; 0 (Imidazoles) ; 0 (Carcinogens) Entry Date(s): Date Created: 20230609 Date Completed: 20230717 Latest Revision: 20230718 Update Code: 20240514

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