Luseogliflozin: First global approval

Drugs

Volumn 74, Issue 8, 2014, Pages 945-950

  Markham, Anthony ^b   Elkinson, Shelley ^a  

^a Adis R and D Insight   (New Zealand)

^b ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

LUSEFI; LUSEOGLIFLOZIN; UNCLASSIFIED DRUG; 1,5-ANHYDRO-1-(5-(4-ETHOXYBENZYL)-2-METHOXY-4-METHYLPHENYL)-1-THIOGLUCITOL; ANTIDIABETIC AGENT; SODIUM GLUCOSE COTRANSPORTER 2; SORBITOL;

ARTICLE; DIABETIC PATIENT; DRUG APPROVAL; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; GENITAL TRACT INFECTION; HUMAN; HYPOGLYCEMIA; JAPAN; JAPANESE (PEOPLE); MONOTHERAPY; NON INSULIN DEPENDENT DIABETES MELLITUS; NONHUMAN; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); POLLAKISURIA; RANDOMIZED CONTROLLED TRIAL (TOPIC); URINARY TRACT INFECTION; ANALOGS AND DERIVATIVES; ANIMAL; ANTAGONISTS AND INHIBITORS; DIABETES MELLITUS, TYPE 2; DRUG COMBINATION; ORAL DRUG ADMINISTRATION; PATHOPHYSIOLOGY;

ADMINISTRATION, ORAL; ANIMALS; DIABETES MELLITUS, TYPE 2; DRUG APPROVAL; DRUG THERAPY, COMBINATION; HUMANS; HYPOGLYCEMIC AGENTS; JAPAN; SODIUM-GLUCOSE TRANSPORTER 2; SORBITOL;

EID: 84902240389     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.1007/s40265-014-0230-8     Document Type: Article

References (23)

1. Abdul-Ghani MA, Norton L, DeFronzo RA. Efficacy and safety of SGLT2 inhibitors in the treatment of type 2 diabetes mellitus. Curr Diabetes Rep. 2012;12(3):230-8.
2. Vasilakou D, Karagiannis T, Athanasiadou E, et al. Sodium-glucose cotransporter 2 inhibitors for type 2 diabetes: A systematic review and meta-analysis. Ann Intern Med. 2013;159(4):262-74.
3. Taisho P. Acquisition of Manufacturing and Marketing Approval in Japan for SGLT2 Inhibitor Lusefi(Rm) Tablets 2.5 mg and Lusefi(Rm) Tablets 5 mg [media release. http://www.taisho-holdings.co.jp ]. 24 Mar 2014.
4. Novartis. Lusefi (luseogliflozin): Japanese prescribing information [In Japanese]. 2014. http://medical.taishotoyama.co.jp/cgi-bin/index2-n.cgi?mode= sel&rows=86&caut=tenp&page=/data/tenp/pdf/tenp-lsf.pdf. Accessed 11 May 2014.
5. Taisho Pharmaceutical Holdings Co L. Signing of Domestic Sales Rights Licensing Agreement Regarding SGLT2 Inhibitor TS-071 [media release]. http://www.taisho-holdings.co.jp. 30 Nov 2012.
6. Kakinuma H, Oi T, Hashimoto-Tsuchiya Y, et al. (1S)-1,5-anhydro-1-[5-(4- ethoxybenzyl)-2-methoxy-4-methylphenyl]-1-thio-D-glucitol (TS-071) is a potent, selective sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for type 2 diabetes treatment. J Med Chem. 2010;53(8):3247-61.
7. Teisuke T, Kozakai A, Kojima N, et al. Long-term treatment of TS-071, a novel, potent and selective SGLT2 inhibitor, improves hyperglycaemia and prevents the loss of beta cell in diabetic mice. Diabetologia. 2011;54:S345.
8. Yamamoto K, Uchida S, Kitano K, et al. TS-071 is a novel, potent and selective renal sodium-glucose cotransporter 2 (SGLT2) inhibitor with anti-hyperglycaemic activity. Br J Pharmacol. 2011;164(1):181-91.
9. Uchida S, Takahashi T, Tomoike H, et al. TS-071, a novel, potent and selective SGLT2 inhibitor, induces weight loss and a reduction in adipocyte size in diet-induced obese rats. Diabetes. 2011;60:A274.
10. Sasaki T, Seino Y, Fukatsu A, et al. Safety, pharmacokinetics, and pharmacodynamics of single and multiple luseogliflozin dosing in healthy Japanese males: a randomized, single-blind, placebo-controlled trial. Adv Ther. 2014;31(3):345-61.
11. Sasaki T, Seino Y, Fukatsu A, et al. TS-071, a novel potent and highly selective renal sodium-glucose co- transporter 2 (SGLT2) inhibitor, increases urinary glucose excretion and reduces plasma glucose levels in Japanese patients with type 2 diabetes mellitus. 47th Annual Meeting of the European Association for the Study of Diabetes. 2011:abstr. 846.
12. Morrow LA, Guttierrez MJ, Tanaka Y, et al. Luseogliflozin (TS-071), a novel, potent, and selective inhibitor of SGLT2 is safe and well-tolerated in type 2 diabetes mellitus and showed dosedependent PK/PD in both US/Japanese ethnicities. Diabetologia. 2012;55:S304.
13. Haneda M, Seino Y, Sasaki T, et al. The effect of luseogliflozin (TS-071), a selective SGLT2 inhibitor, on pharmacodynamics and pharmacokinetics in Japanese type 2 diabetic subjects with renal impairment. Diabetes. 2012;61:A273.
14. Sasaki T, Seino Y, Samukawa Y, et al. Effects of gender and age on the pharmacokinetics and pharmacodynamics of luseogliflozin (TS-071), a selective SGLT2 inhibitor. Diabetes. 2012;61:A275.
15. Nakai Y, Mutoh M. Luseogliflozin (TS-071) a novel, potent and selective sglt2 inhibitor, did not affect the PK of several oral diabetic agents in clinical. Diabetes. 2012;61:A607.
16. Inagaki N, Seino Y, Sasaki T, et al. Luseogliflozin, a selective SGLT2 inhibitor, added on to glimepiride for 52 weeks improves glycaemic control with no major hypoglycaemia in Japanese type 2 diabetes patients. 49th Annual Meeting of the European Association for the Study of Diabetes. 2013:abstr. 184.
17. Haneda M, Seino Y, Sasaki T, et al. Luseogliflozin, a SGLT2 inhibitor, as add-on therapy to 5 types of oral antidiabetic drugs improves glycaemic control and reduces body weight in Japanese patients with type 2 diabetes mellitus. 49th Annual Meeting of the European Association for the Study of Diabetes. 2013:abstr. 957.
18. Seino Y, Sasaki T, Fukatsu A, et al. Luseogliflozin, a selective SGLT2 inhibitor, improves glycemic control as monotherapy in Japanese patients with T2DM. World Diabetes Congress 2013. 2013:abstr. P-1472.
19. Seino Y, Sasaki T, Fukatsu A, et al. Efficacy and safety of luseogliflozin as monotherapy in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled, phase 3 study. Curr Med Res Opin. 2014. doi: 10.1185/03007995.2014.912983.
20. Seino Y, Sasaki T, Fukatsu A, et al. Dose-finding study of luseogliflozin in Japanese patients with type 2 diabetes mellitus: a 12-week, randomized, double-blind, placebo-controlled, phase II study. Curr Med Res Opin. 2014. doi: 10.1185/03007995.2014.909390:1-14.
21. Seino Y, Sasaki T, Fukatsu A, et al. TS-071, a Novel and Selective SGLT2 Inhibitor, Improved Glycemic Control and Decreased Body Weight in 12-Week Study of Japanese Patients with Type 2 Diabetes Mellitus. 71st Annual Scientific Sessions of the American Diabetes Association. 2011:abstr. 0998-P.
22. Seino Y, Sasaki T, Fukatsu A, et al. TS-071, a novel and selective SGLT2 inhibitor, improved glycemic control and decreased body weight in 12-week study of Japanese patients with type 2 diabetes mellitus. Diabetes. 2011;60:A274.
23. Seino Y, Sasaki T, Fukatsu A, et al. Luseogliflozin (TS-071), a selective SGLT2 inhibitor, improves glycaemic control and lowers body weight in a 12-week study in Japanese patients with type 2 diabetes mellitus. 48th Annual Meeting of the European Association for the Study of Diabetes. 2012:abstr. 740.