Category «APPROVALS 2020»

Tucatinib

Tucatinib ツカチニブ; N6-(4,4-dimethyl-4,5-dihydro-1,3-oxazol-2-yl)-N4-(3-methyl-4-{[1,2,4]triazolo[1,5-a]pyridin-7-yloxy}phenyl)quinazoline-4,6-diamine Formula C26H24N8O2 CAS 937263-43-9 Mol weight 480.5212 To treat advanced unresectable or metastatic HER2-positive breast cancer Drug Trials Snapshot FDA APPROVED 4/17/2020 Tukysa ARRY 380 ARRY-380 ONT 380 ONT-380 Tucatinib (INN),[1] sold under the brand name Tukysa, is a small molecule inhibitor of HER2 for the treatment of HER2-positive breast cancer.[2][3] It was developed by Array BioPharma and licensed to Cascadian Therapeutics …

Ripretinib

Ripretinib リプレチニブ; Formula C24H21BrFN5O2 CAS 1442472-39-0 Mol weight 510.3582 Antineoplastic, Receptor tyrosine kinase inhibitor US FDA APPROVED 2020/5/15 QUINLOCK NAME DOSAGE STRENGTH ROUTE LABELLER MARKETING START MARKETING END Qinlock Tablet 50 mg Oral Deciphera Pharmaceuticals. Llc Not applicable Not applicable Qinlock Tablet 50 mg/1 Oral Deciphera Pharmaceuticals, LLC 2020-05-15 Not applicable SYN Ripretinib, sold under the …

Cetuximab sarotalocan sodium

Cetuximab Sarotalocan Sodium (Genetical Recombination) Cetuximab Sarotalocan Sodium is an antibody-drug-conjugate (molecular weight: 156,000-158,000) consisting of tetrasodium salt of Sarotalocan (6-({[3-({(OC-6-13)-bis({3-[bis(3-sulfopropyl)(3-sulfonatopropyl)azaniumyl]propyl}dimethylsilanolato-κO,κO‘)[(phtalocyaninato(2-)κN29,κN30,κN31,κN32)-1-yl]silicon}oxy)propoxy]carbonyl}amino)hexanoyl (C70H96N11O24S6Si3; molecular weight: 1,752.22)) attached to an average of 2-3 Lys residues of Cetuximab. [2166339-33-7 , Cetuximab sarotalocan] Cetuximab sarotalocan sodium JAPAN 2020/9/25APPROVED AKALUX Antineoplastic セツキシマブサロタロカンナトリウム (遺伝子組換え) Originator Aspyrian Therapeutics Developer Rakuten Medical Class Antineoplastics; Drug conjugates; Immunoconjugates; Monoclonal …

Enarodustat

Enarodustat エナロデュスタット JTZ 951 Formula C17H16N4O4 CAS 1262132-81-9 Mol weight 340.3333 PMDA 2020/9/25 APPROVED ENAROY Anti-anemic, Hypoxia inducible factor-prolyl hydroxylase (HIF-PH) inhibitor Originator Japan Tobacco Developer Japan Tobacco; JW Pharmaceutical Class Acetic acids; Amides; Antianaemics; Pyridones; Small molecules; Triazoles Mechanism of Action Hypoxia-inducible factor-proline dioxygenase inhibitors Preregistration Anaemia 27 Dec 2019 Japan Tobacco and SalubrisBio …

Sofpironium bromide ソフピロニウム臭化物

Sofpironium bromide ソフピロニウム臭化物 BBI 4000 [(3R)-1-(2-ethoxy-2-oxoethyl)-1-methylpyrrolidin-1-ium-3-yl] (2R)-2-cyclopentyl-2-hydroxy-2-phenylacetate;bromide Formula C22H32NO5. Br CAS 1628106-94-4 BASE 1628251-49-9 Mol weight 470.3972 PMDA APPROVED JAPAN 2020/9/25, Ecclock Anhidrotic Sofpironium Bromide 1-ambo-(3R)-3-{[(R)-(Cyclopentyl)hydroxy(phenyl)acetyl]oxy}-1-(2-ethoxy-2-oxoethyl)-1-methylpyrrolidinium bromide C22H32BrNO5 : 470.4 [1628106-94-4] SYN PATENT WO 2018026869 https://patents.google.com/patent/WO2018026869A1/en Certain glycopyrronium salts and related compounds, as well as processes for making and methods of using these glycopyrronium salts and related compounds, are known. See, …

Pralsetinib

Pralsetinib Formula C27H32FN9O2 CAS 2097132-94-8 Mol weight 533.6005 Cyclohexanecarboxamide, N-[(1S)-1-[6-(4-fluoro-1H-pyrazol-1-yl)-3-pyridinyl]ethyl]-1-methoxy-4-[4-methyl-6-[(5-methyl-1H-pyrazol-3-yl)amino]-2-pyrimidinyl]-, cis– 2097132-94-8 [RN] BLU-667 BS-15942 Other Names cis-N-[(1S)-1-[6-(4-Fluoro-1H-pyrazol-1-yl)-3-pyridinyl]ethyl]-1-methoxy-4-[4-methyl-6-[(5-methyl-1H-pyrazol-3-yl)amino]-2-pyrimidinyl]cyclohexanecarboxamide BLU 123244 BLU 667 Pralsetinib X 581238 cis-N-{(1S)-1-[6-(4-fluoro-1H-pyrazol-1-yl)pyridin-3-yl]ethyl}-1-methoxy-4-{4-methyl-6-[(5-methyl-1H-pyrazol-3-yl)amino]pyrimidin-2-yl}cyclohexane-1-carboxamide N-[(1S)-1-[6-(4-fluoropyrazol-1-yl)pyridin-3-yl]ethyl]-1-methoxy-4-[4-methyl-6-[(5-methyl-1H-pyrazol-3-yl)amino]pyrimidin-2-yl]cyclohexane-1-carboxamide FDA APPROVED GAVRETO, 2020/9/4 Pralsetinib, sold under the brand name Gavreto, is a medication for the treatment of metastatic RET fusion-positive non-small cell lung cancer (NSCLC).[1] Pralsetinib is a tyrosine kinase inhibitor. It is …

Somapacitan, ソマパシタン;

FPTIPLSRLF DNAMLRAHRL HQLAFDTYQE FEEAYIPKEQ KYSFLQNPQT SLCFSESIPT PSNREETQQK SNLELLRISL LLIQSWLEPV QFLRSVFANS CVYGASDSNV YDLLKDLEEG IQTLMGRLED GSPRTGQIFK QTYSKFDTNS HNDDALLKNY GLLYCFRKDM DKVETFLRIV QCRSVEGSCG F (Disulfide bridge: 53-165, 182-189) Somapacitan FDA APPROVED, 2020/8/28, SOGROYA Growth hormone (GH) receptor agonist CAS: 1338578-34-9 (2S)-5-[2-[2-[2-[[(2S)-1-amino-6-[[2-[(2R)-2-amino-2-carboxyethyl]sulfanylacetyl]amino]-1-oxohexan-2-yl]amino]-2-oxoethoxy]ethoxy]ethylamino]-2-[[(4S)-4-carboxy-4-[[2-[2-[2-[4-[16-(2H-tetrazol-5-yl)hexadecanoylsulfamoyl]butanoylamino]ethoxy]ethoxy]acetyl]amino]butanoyl]amino]-5-oxopentanoic acid Formula C1038H1609N273O319S9 Mol weight 23305.1048 JAP ソマパシタン; Treatment of growth hormone dificiency albumin-binding growth hormone UNII-8FOJ430U94 8FOJ430U94 NN8640 UNII-F1 …

Lactitol, ラクチトール

Lactitol ラクチトール; Formula C12H24O11 CAS 585-86-4 Mol weight 344.3124 To treat chronic idiopathic constipation (CIC) in adults FDA 2/12/2020, APPROVED, Pizensy Lactitol, NS-4, Portolac, Importal Lactitol CAS Registry Number: 585-86-4 CAS Name: 4-O-b-D-Galactopyranosyl-D-glucitol Additional Names: b-galactoside sorbitol; lactit; lactit M; lactite; lactobiosit; lactosit; lactositol Molecular Formula: C12H24O11 Molecular Weight: 344.31 Percent Composition: C 41.86%, H 7.03%, O 51.11% Literature References: Polyol sweetener; relative sweetness …

Eptinezumab エプチネズマブ;

Eptinezumab エプチネズマブ; (Heavy chain) EVQLVESGGG LVQPGGSLRL SCAVSGIDLS GYYMNWVRQA PGKGLEWVGV IGINGATYYA SWAKGRFTIS RDNSKTTVYL QMNSLRAEDT AVYFCARGDI WGQGTLVTVS SASTKGPSVF PLAPSSKSTS GGTAALGCLV KDYFPEPVTV SWNSGALTSG VHTFPAVLQS SGLYSLSSVV TVPSSSLGTQ TYICNVNHKP SNTKVDARVE PKSCDKTHTC PPCPAPELLG GPSVFLFPPK PKDTLMISRT PEVTCVVVDV SHEDPEVKFN WYVDGVEVHN AKTKPREEQY ASTYRVVSVL TVLHQDWLNG KEYKCKVSNK ALPAPIEKTI SKAKGQPREP QVYTLPPSRE EMTKNQVSLT CLVKGFYPSD IAVEWESNGQ PENNYKTTPP VLDSDGSFFL YSKLTVDKSR WQQGNVFSCS VMHEALHNHY TQKSLSLSPG K (Light chain) QVLTQSPSSL SASVGDRVTI NCQASQSVYH NTYLAWYQQK …

Teprotumumab-trbw

Tepezza (teprotumumab-trbw) Company: Horizon Therapeutics plc Date of Approval: January 21, 2020 Treatment for: Thyroid Eye Disease Labels for BLA 761143 UNIIY64GQ0KC0A CAS number1036734-93-6 R-1507 / R1507 / RG-1507 / RG1507 / RO-4858696 / RO-4858696-000 / RO-4858696000 / RO4858696 / RO4858696-000 / RV-001 / RV001 Tepezza (teprotumumab-trbw) is a fully human monoclonal antibody (mAb) and a targeted inhibitor of the insulin-like growth factor 1 receptor (IGF-1R) for the treatment of active thyroid eye disease (TED). FDA Approves Tepezza …