Topiroxostat for gout and hyperuricemia

New Drug Approvals

 

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Topiroxostat

托匹司他

FUJI YAKUHIN  ……..INNOVATOR

Approved in japan PMDA JUNE 28 2013

Xanthine oxidase inhibitor

FOR GOUT AND HYPERURICEMIA

Launched – 2013, Fuji YakuhinSanwa, Topiloric  Uriadec

IUPAC Name: 4-(5-pyridin-4-yl-1H-1,2,4-triazol-3-yl)pyridine-2-carbonitrile

CAS Registry Number: 577778-58-6

4 – [5 – (pyridin-4 – yl)-1H-1, 2,4 – triazol-3 – yl] pyridine-2 – carbonitrile (1)

5-(2-cyano-4-pyridyl)-3-(4-pyridyl)-1,2,4-triazole

3-(3-cyano-4-pyridyl)-5-(4-pyridyl)-1,2,4-triazole
Synonyms: 4-(5-PYRIDIN-4-YL-1H-1,2,4-TRIAZOL-3-YL)PYRIDINE-2-CARBONITRILE,

AC1NRB9T, Topiroxostat (JAN/INN),  DB01685, D09786, FYX-051
SK-0910

4-[5-PYRIDIN-4-YL-1H-[1,2,4]TRIAZOL-3-YL]-PYRIDINE-2-CARBONITRILE,

C13H8N6 MF,248.2482 MW

TOPIROXOSTAT

托匹司他

A xanthine oxidase inhibitor used to treat gout and hyperuricemia.

PATENT EXP 3/12/22, US /EU/CN

 

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FYX-051, TOPIROXOSTAT is a xanthine oxidase inhibitor. This agent was approved in Japan by Fuji Yakuhin and Sanwa for the treatment of gout and hyperuricemia in 2013 and launched at the same year. In 2009, the compound was licensed to Sanwa by Fuji Yakuhin in Japan for the codevelopment and commercialization of gout.

The number of patients with hyperuricemia in Japan is reported…

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SUMATRIPTAN …Avanir files new drug application for migraine drug

New Drug Approvals

SUMATRIPTAN, GR-43175

1-[3-(2-dimethylaminoethyl)-1H-indol-5-yl]- N-methyl-methanesulfonamide

3-[2-(Dimethylamino)ethyl]-N-methyl-1H-indole-5-methanesulfonamide

Formula C14H21N3O2S 
Mol. mass 295.402 g/mol
CAS number 103628-46-2 
 
Melting point: mp 169-171°
Therap-Cat: Antimigraine.
Keywords: Antimigraine; Serotonin Receptor Agonist.
NDA 020626,GSK, IMITREX, 1997

Avanir Pharmaceuticals has filed a new drug application (NDA) with the US Food and Drug Administration (FDA) for approval of its new breath-powered investigational drug-device combination product, ‘AVP-825’, for the acute treatment of migraines.  click on title  Avanir files new drug application for migraine drug 

Sumatriptan moleculeSUMATRIPTAN

SUMATRIPTAN SUCCINATE

CAS Registry Number:
103628-48-4 ((1:1) salt), 103628-47-3 ((2:1) salt), 103628-46-2 (free base)
GlaxoSmithKline (Originator), Atrix (Formulation), Nastech (Formulation), NovaDel Pharma (Formulation)
Manufacturers’ Codes: GR-43175C
Trademarks: Imigran (GSK); Imitrex (GSK); Imiject (GSK)
Molecular Formula: C14H21N3O2S.C4H6O4
Molecular Weight: 413.49
Percent Composition: C 52.28%, H 6.58%, N 10.16%, O 23.22%, S 7.75%
Properties: mp 165-166°.
Melting point:

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How to Handle Drug Polymorphs… Case Study of Trelagliptin Succinate

New Drug Approvals

Pharmaceutical API Polymorphs… case study of Trelagliptin
CASE STUDY WITH..Compound I having the formula
Figure imgf000073_0001
Links
WO2008067465A1 OR US8084605  IS THE PATENT USED AND WITH FORM “A” AND AMORPHOUS FORM
Active pharmaceutical ingredients (APIs), frequently delivered to the patient in the solid-state as part of an approved dosage form, can exist in such diverse solid forms as polymorphs, pseudopolymorphs, salts, co-crystals and amorphous solids. Various solid forms often display different mechanical, thermal, physical and chemical properties that can remarkably influence the bioavailability, hygroscopicity, stability and other performance characteristics of the drug.
Hence, a thorough understanding of the relationship between the particular solid form of an active pharmaceutical ingredient (API) and its functional properties is important in selecting the most suitable form of the API for development into a drug product. In past decades, there have been significant efforts on the discovery, selection and control…

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