Category «FDA 2020»

Isatuximab

It’s only fair to share… (A chain) QVQLVQSGAE VAKPGTSVKL SCKASGYTFT DYWMQWVKQR PGQGLEWIGT IYPGDGDTGY AQKFQGKATL TADKSSKTVY MHLSSLASED SAVYYCARGD YYGSNSLDYW GQGTSVTVSS ASTKGPSVFP LAPSSKSTSG GTAALGCLVK DYFPEPVTVS WNSGALTSGV HTFPAVLQSS GLYSLSSVVT VPSSSLGTQT YICNVNHKPS NTKVDKKVEP KSCDKTHTCP PCPAPELLGG PSVFLFPPKP KDTLMISRTP EVTCVVVDVS HEDPEVKFNW YVDGVEVHNA KTKPREEQYN STYRVVSVLT VLHQDWLNGK EYKCKVSNKA LPAPIEKTIS KAKGQPREPQ VYTLPPSRDE LTKNQVSLTC LVKGFYPSDI AVEWESNGQP ENNYKTTPPV LDSDGSFFLY SKLTVDKSRW QQGNVFSCSV MHEALHNHYT QKSLSLSPGK (B chain) QVQLVQSGAE …

Berotralstat

It’s only fair to share… Berotralstat CAS  1809010-50-1 DIHCl 1809010-52-3 Molecular Formula, C30-H26-F4-N6-O, Molecular Weight, 562.5684 1-(3-(Aminomethyl)phenyl)-N-(5-((R)-(3-cyanophenyl)((cyclopropylmethyl)amino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-1H-pyrazole-5-carboxamide 1H-Pyrazole-5-carboxamide, 1-(3-(aminomethyl)phenyl)-N-(5-((R)-(3-cyanophenyl)((cyclopropylmethyl)amino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)- To treat patients with hereditary angioedema FDA APPROVED 12/4/2020, Orladeyo, 110MG CAPSULE 0RAL New Drug Application (NDA): 214094 Company: BIOCRYST PHARMACEUTICALS INC New Drug Application (NDA): 214094 Company: BIOCRYST PHARMACEUTICALS INC Berotralstat Hydrochloride 1-[3-(Aminomethyl)phenyl]-N-(5-{(1R)-(3-cyanophenyl)[(cyclopropylmethyl)amino]methyl}-2-fluorophenyl)-3-(trifluoromethyl)-1H-pyrazole-5-carboxamide dihydrochloride C30H26F4N6O▪2HCl : 635.48 [1809010-52-3] Berotralstat, also known as BCX-7353, is a kallikrein inhibitor. BCX7353 …

Viltolarsen

It’s only fair to share… Viltolarsen 维托拉生 ビルトラルセン Formula C244H381N113O88P20 CAS  2055732-84-6 Mol weight 6924.8155 APPROVED FDA 2020/8/12, Viltepso APPROVED JAPAN PMDA 2020/3/25, VILTEPSO   NCNP-01 NS-065 NS-065/NCNP-01 WHO 10771 WHO-10771 NAME DOSAGE STRENGTH ROUTE LABELLER MARKETING START MARKETING END Viltepso Injection, solution 250 mg/1 Intravenous Ns Pharma, Inc. 2020-08-13 Not applicable SYN Watanabe N, Nagata T, Satou …

Pemigatinib

It’s only fair to share…   Pemigatinib INCB054828 Formula C24H27F2N5O4 CAS 1513857-77-6 2379919-96-5  HCL Mol weight 487.4991 2020/4/17FDA APPROVED, PEMAZYRE 佩米替尼 [Chinese] [INN] 3-(2,6-Difluoro-3,5-dimethoxyphenyl)-1-ethyl-8-(morpholinomethyl)-1,3,4,6-tetrahydro-2H-pyrrolo[3′,2′:5,6]pyrido[4,3-d]pyrimidin-2-one 2H-Pyrrolo[3′,2′:5,6]pyrido[4,3-d]pyrimidin-2-one, 3-(2,6-difluoro-3,5-dimethoxyphenyl)-1-ethyl-1,3,4,7-tetrahydro-8-(4-morpholinylmethyl)- 3-(2,6-difluoro-3,5-dimethoxyphenyl)-1-ethyl-8-(morpholin-4-ylmethyl)-1,3,4,7-tetrahydro-2H-pyrrolo[3′,2′:5,6]pyrido[4,3-d]pyrimidin-2-one OriginatorIncyte Corporation DeveloperIncyte Corporation; Innovent Biologics ClassAntineoplastics; Ethers; Fluorobenzenes; Morpholines; Pyridines; Pyrimidinones; Pyrroles; Small molecules Mechanism of ActionType 1 fibroblast growth factor receptor antagonists; Type 3 fibroblast growth factor receptor …

Tucatinib

It’s only fair to share…   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 …

Ripretinib

It’s only fair to share… 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 …

Triheptanoin

It’s only fair to share…   Triheptanoin Approved US FDA 30/6/2020 Dojolvi UX 007 Triheptanoin is a source of heptanoate fatty acids, which can be metabolized without the enzymes of long chain fatty acid oxidation.4 In clinical trials, patients with long chain fatty acid oxidation disorders (lc-FAODs) treated with triheptanoin are less likely to develop hypoglycemia, cardiomyopathy, …

Abametapir アバメタピル , абаметапир , أباميتابير , 阿巴甲吡 ,

It’s only fair to share…   Abametapir アバアバメタピル , абаметапир , أباميتابير , 阿巴甲吡 , 5,5′-dimethyl-2,2′-bipyridine, 6,6′-Bi-3-picoline BRN 0123183 HA 44 HA-44 HA44 Formula C12H12N2 CAS 1762-34-1 Mol weight 184.2371 Xeglyze, FD APPROVED 24/7/2020 Pediculicide, Metalloproteinase inhibitor   Disease Head lice infestation Originator Hatchtech DeveloperDr Reddys Laboratories; Hatchtech ClassAntiparasitics; Heterocyclic compounds; Pyridines; Small molecules Mechanism of ActionChelating agents; Metalloprotease inhibitors Registered Pediculosis 27 Jul …

Nifurtimox

It’s only fair to share… Nifurtimox Formula C10H13N3O5S CAS 23256-30-6 Mol weight 287.2923 FDA APPROVED, 2020/8/6, LAMPIT Antiprotozoal   Disease Chagas disease IUPAC Name 3-methyl-4-[(E)-[(5-nitrofuran-2-yl)methylidene]amino]-1lambda6-thiomorpholine-1,1-dione SMILES CC1CS(=O)(=O)CCN1\N=C\C1=CC=C(O1)[N+]([O-])=O SYN Danong Chen, Glenn Rice. 2013. Novel formulations of nitrofurans including nifurtimox with enhanced activity with lower toxicity.US20150140089A1 melting point (°C) 177-183 https://www.chemicalbook.com/ChemicalProductProperty_US_CB3903922.aspx OriginatorBayer ClassAntiprotozoals; Nitrofurans; Small molecules; Thiamorpholines; Thiazines …

Pralsetinib

It’s only fair to share… 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 …