Pegozafermin

Pegozafermin
Clinical data
Other names	BIO89-100; TEV-47948
Legal status
Legal status	Investigational;
Identifiers
CAS Number	2489589-60-6;
UNII	UO870O6MFS;

Pegozafermin (BIO89-100) is a long-acting, glycopegylated FGF21 analog developed for the treatment of nonalcoholic steatohepatitis and hypertriglyceridemia.^[1]^[2]^[3]^[4]

References[edit]

^ Loomba, Rohit; Sanyal, Arun J.; Kowdley, Kris V.; Bhatt, Deepak L.; Alkhouri, Naim; Frias, Juan P.; Bedossa, Pierre; Harrison, Stephen A.; Lazas, Donald; Barish, Robert; Gottwald, Mildred D.; Feng, Shibao; Agollah, Germaine D.; Hartsfield, Cynthia L.; Mansbach, Hank; Margalit, Maya; Abdelmalek, Manal F. (14 September 2023). "Randomized, Controlled Trial of the FGF21 Analogue Pegozafermin in NASH". New England Journal of Medicine. 389 (11): 998–1008. doi:10.1056/NEJMoa2304286. PMC 10718287.
^ Bhatt, Deepak L.; Bays, Harold E.; Miller, Michael; Cain, James E.; Wasilewska, Katarzyna; Andrawis, Nabil S.; Parli, Teresa; Feng, Shibao; Sterling, Lulu; Tseng, Leo; Hartsfield, Cynthia L.; Agollah, Germaine D.; Mansbach, Hank; Kastelein, John J. P. (July 2023). "The FGF21 analog pegozafermin in severe hypertriglyceridemia: a randomized phase 2 trial". Nature Medicine. 29 (7): 1782–1792. doi:10.1038/s41591-023-02427-z. ISSN 1546-170X. PMC 10353930.
^ Loomba, Rohit; Lawitz, Eric J; Frias, Juan Pablo; Ortiz-Lasanta, Grisell; Johansson, Lars; Franey, Bridgette Boggess; Morrow, Linda; Rosenstock, Moti; Hartsfield, Cynthia L; Chen, Chao-Yin; Tseng, Leo; Charlton, R Will; Mansbach, Hank; Margalit, Maya (February 2023). "Safety, pharmacokinetics, and pharmacodynamics of pegozafermin in patients with non-alcoholic steatohepatitis: a randomised, double-blind, placebo-controlled, phase 1b/2a multiple-ascending-dose study". The Lancet Gastroenterology & Hepatology. 8 (2): 120–132. doi:10.1016/S2468-1253(22)00347-8.
^ Alkhouri, Naim; Lazas, Donald; Loomba, Rohit; Frias, Juan P.; Feng, Shibao; Tseng, Leo; Balic, Kemal; Agollah, Germaine D.; Kwan, Tinna; Iyer, Janani S.; Morrow, Linda; Mansbach, Hank; Margalit, Maya; Harrison, Stephen A. (November 2023). "Clinical trial: Effects of pegozafermin on the liver and on metabolic comorbidities in subjects with biopsy‐confirmed nonalcoholic steatohepatitis". Alimentary Pharmacology & Therapeutics. 58 (10): 1005–1015. doi:10.1111/apt.17709.

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[1] Loomba, Rohit; Sanyal, Arun J.; Kowdley, Kris V.; Bhatt, Deepak L.; Alkhouri, Naim; Frias, Juan P.; Bedossa, Pierre; Harrison, Stephen A.; Lazas, Donald; Barish, Robert; Gottwald, Mildred D.; Feng, Shibao; Agollah, Germaine D.; Hartsfield, Cynthia L.; Mansbach, Hank; Margalit, Maya; Abdelmalek, Manal F. (14 September 2023). "Randomized, Controlled Trial of the FGF21 Analogue Pegozafermin in NASH". New England Journal of Medicine. 389 (11): 998–1008. doi:10.1056/NEJMoa2304286. PMC 10718287.

[2] Bhatt, Deepak L.; Bays, Harold E.; Miller, Michael; Cain, James E.; Wasilewska, Katarzyna; Andrawis, Nabil S.; Parli, Teresa; Feng, Shibao; Sterling, Lulu; Tseng, Leo; Hartsfield, Cynthia L.; Agollah, Germaine D.; Mansbach, Hank; Kastelein, John J. P. (July 2023). "The FGF21 analog pegozafermin in severe hypertriglyceridemia: a randomized phase 2 trial". Nature Medicine. 29 (7): 1782–1792. doi:10.1038/s41591-023-02427-z. ISSN 1546-170X. PMC 10353930.

[3] Loomba, Rohit; Lawitz, Eric J; Frias, Juan Pablo; Ortiz-Lasanta, Grisell; Johansson, Lars; Franey, Bridgette Boggess; Morrow, Linda; Rosenstock, Moti; Hartsfield, Cynthia L; Chen, Chao-Yin; Tseng, Leo; Charlton, R Will; Mansbach, Hank; Margalit, Maya (February 2023). "Safety, pharmacokinetics, and pharmacodynamics of pegozafermin in patients with non-alcoholic steatohepatitis: a randomised, double-blind, placebo-controlled, phase 1b/2a multiple-ascending-dose study". The Lancet Gastroenterology & Hepatology. 8 (2): 120–132. doi:10.1016/S2468-1253(22)00347-8.

[4] Alkhouri, Naim; Lazas, Donald; Loomba, Rohit; Frias, Juan P.; Feng, Shibao; Tseng, Leo; Balic, Kemal; Agollah, Germaine D.; Kwan, Tinna; Iyer, Janani S.; Morrow, Linda; Mansbach, Hank; Margalit, Maya; Harrison, Stephen A. (November 2023). "Clinical trial: Effects of pegozafermin on the liver and on metabolic comorbidities in subjects with biopsy‐confirmed nonalcoholic steatohepatitis". Alimentary Pharmacology & Therapeutics. 58 (10): 1005–1015. doi:10.1111/apt.17709.

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