Tag «FDA 2025»

Aceclidine

It’s only fair to share… Aceclidine WeightAverage: 169.224Monoisotopic: 169.110278727 Chemical FormulaC9H15NO2 CAS 827-61-2, 3-Acetoxyquinuclidine, 3-Quinuclidinol acetate (ester), Aceclidina, 0578K3ELIO APROVAL 7/31/2025, Vizz. To treat presbyopia 1-azabicyclo[2.2.2]octan-3-yl acetate Acetic acid 1-aza-bicyclo[2.2.2]oct-3-yl ester(aceclidine) MW: 169.22 MF: C9H15NO2LD50: 78 mg/kg (M, i.p.); 36 mg/kg (M, i.v.); 165 mg/kg (M, p.o.); 102 mg/kg (M, s.c.);45 mg/kg (R, i.v.); 225 …

Sepiapterin

It’s only fair to share… Sepiapterin 17094-01-8 Molecular Weight 237.22 Formula C9H11N5O3 2-amino-6-[(2S)-2-hydroxypropanoyl]-7,8-dihydro-3H-pteridin-4-one (S)-2-Amino-6-(2-hydroxypropanoyl)-7,8-dihydropteridin-4(3H)-one 7/28/2025 fda approved, Sephience, To treat hyperphenylalaninemia in patients with sepiapterin-responsive phenylketonuria, in conjunction with a phenylalanine-restricted diet Sepiapterin, sold under the brand name Sephience, is a medication used for the treatment of hyperphenylalaninemia.[2][3] Sepiapterin is a phenylalanine hydroxylase activator.[1] The most common side effects are upper respiratory …

Sebetralstat

It’s only fair to share… Sebetralstat, KVD 900 CAS 1933514-13-6 491.5 g/mol O5ZD2TU2B7 FDA 7/3/2025, Ekterly, To treat acute attacks of hereditary angioedema N-[(3-fluoro-4-methoxypyridin-2-yl)methyl]-3-(methoxymethyl)-1-[[4-[(2-oxopyridin-1-yl)methyl]phenyl]methyl]pyrazole-4-carboxamide Sebetralstat, sold under the brand name Ekterly, is a medication used for the treatment of hereditary angioedema.[1] Sebetralstat is a plasma kallikrein inhibitor.[1] Sebetralstat was approved for medical use in the United States in July 2025.[1][2] SYN https://pubs.acs.org/doi/10.1021/acs.jmedchem.2c00921 aReagents …

Sunvozertinib

It’s only fair to share… Sunvozertinib CAS 2370013-12-8 DZD9008, 584.1 g/mol, C29H35ClFN7O3, A-1801, L1Q2K5JYO8 N-[5-[[4-[5-chloro-4-fluoro-2-(2-hydroxypropan-2-yl)anilino]pyrimidin-2-yl]amino]-2-[(3R)-3-(dimethylamino)pyrrolidin-1-yl]-4-methoxyphenyl]prop-2-enamide FDA Zegfrovy, 7/2/2025 To treat locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test, with disease progression on or after platinum-based chemotherapy Sunvozertinib (DZD9008) is a potent ErbBs (EGFR, …

PALTUSOTINE

It’s only fair to share… PALTUSOTINE CAS 2172870-89-0 WeightAverage: 456.497Monoisotopic: 456.17616767 Chemical FormulaC27H22F2N4O 3-[4-(4-Amino-1-piperidinyl)-3-(3,5-difluorophenyl)-6-quinolinyl]-2-hydroxybenzonitrile fda 2025, approvals 2025 To treat acromegaly in adults who had an inadequate response to surgery and/or for whom surgery is not an option Paltusotine is a selective somatostatin receptor type 2 (SST2) agonist in development by Crinetics Pharmaceuticals for the treatment of acromegaly and certain …

ATRASENTAN

It’s only fair to share… Atrasentan A-147627, (+)-A-127722, ABT-627,173937-91-2, (2R,3R,4S)-4-(1,3-benzodioxol-5-yl)-1-[2-(dibutylamino)-2-oxoethyl]-2-(4-methoxyphenyl)pyrrolidine-3-carboxylic acid Endothelin ET-A antagonist Diabetic nephropathy; End stage renal disease; Renal disease FDA APPROVED 4/02/2025, Vanrafia, To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression 1-(N,N-Dibutylcarbamoylmethyl)-2(R)-(4-methoxyphenyl)-4(S)-(3,4-methylenedioxyphenyl)pyrrolidine-3(R)-carboxylic acid (2R,3R,4S)-(+)-2-(4-Methoxyphenyl)-4-(1,3-benzodioxol-5-yl)-1-(N,N-di(n-butyl)aminocarbonylmethyl)pyrrolidine-3-carboxylic acid (2R,3R,4S)-(+)-2-(4-methoxyphenyl)-4-(1,3-benzodioxol-5-yl)-1-(N,N-di(n-butyl)aminocarbonylmethyl)-pyrrolidine-3-carboxylic acid C29H38N2O6, 510.631 Ingredient UNII CAS InChI Key …

Taletrectinib

It’s only fair to share… Taletrectinib CAS 1505514-27-1 as salt: 1505515-69-4, Taletrectinib adipate  FDA 6/11/2025, Ibtrozi, To treat locally advanced or metastatic ROS1-positive non-small cell lung cancer, ALSO CHINA 2024 AB-106, DS-6051a 405.5 g/mol, C23H24FN5O, UNII-W4141180YD 3-[4-[(2R)-2-aminopropoxy]phenyl]-N-[(1R)-1-(3-fluorophenyl)ethyl]imidazo[1,2-b]pyridazin-6-amine Taletrectinib adipate  WeightAverage: 551.619Monoisotopic: 551.254397378 Chemical FormulaC29H34FN5O5 DS-6051B, CAS 1505515-69-4, 6KLL51GNBG, 3-{4-[(2R)-2-aminopropoxy]phenyl}-N-[(1R)-1-(3-fluorophenyl)ethyl]imidazo[1,2-b]pyridazin-6-amine; hexanedioic acid Taletrectinib, sold under the brand name Ibtrozi, …

Acoltremon

It’s only fair to share… Acoltremon AR-15512 CAS 68489-09-8 WeightAverage: 289.419Monoisotopic: 289.204179113 Chemical FormulaC18H27NO2 FDA 2025, 5/28/2025, To treat the signs and symptoms of dry eye disease Tryptyr WS-12WS 12(1R,2S,5R)-N-(4-methoxyphenyl)-5-methyl-2-(propan-2-yl)cyclohexane-1-carboxamideFema No. 4681N-(4-methoxyphenyl)-p-menthanecarboxamide 1L7BVT4Z4Z Acoltremon sold under the brand name Tryptyr, is a medication used for the treatment of dry eye syndrome.[1] PATENT US 217370 https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2023114986&_fid=RU437402572 https://patentscope.wipo.int/search/en/detail.jsf?docId=US193167995&_cid=P11-MCE7BB-27500-1 https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2012032209&_fid=US193167995 Medical uses Acoltremon …

Nerandomilast

It’s only fair to share… Nerandomilast CAS 1423719-30-5 C20H25ClN6O2S Molecular Weight 448.97 Formula C20H25ClN6O2S I5DGT51IB8 fda 2025, approvals 2025, Jascayd,10/7/2025, To treat idiopathic pulmonary fibrosis [1-[[(5R)-2-[4-(5-chloropyrimidin-2-yl)piperidin-1-yl]-5-oxo-6,7-dihydrothieno[3,2-d]pyrimidin-4-yl]amino]cyclobutyl]methanol Cyclobutanemethanol, 1-[[(5R)-2-[4-(5-chloro-2-pyrimidinyl)-1-piperidinyl]-6,7-dihydro-5-oxidothieno[3,2-d]pyrimidin-4-yl]amino]- 1-[[(5R)-2-[4-(5-Chloro-2-pyrimidinyl)-1-piperidinyl]-6,7-dihydro-5-oxidothieno[3,2-d]pyrimidin-4-yl]amino]cyclobutanemethanol Nerandomilast (BI 1015550) is an investigational oral medication being studied for the treatment of idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). It is a preferential inhibitor …

Fitusiran

It’s only fair to share… Fitusiran 1711.0 g/mol, C78H139N11O30 FDA APPROVED 3/28/2025, Qfitlia, To prevent or reduce the frequency of bleeding episodes in hemophilia A or BPress Release Fitusiran Sodium 43 Sodium salt of duplex of [(2S,4R)-1-{1-[(2-acetamido-2-deoxy-β-D-galactopyranosyl)oxy]-16,16-bis({3-[(3-{5-[(2-acetamido-2-deoxy-β-D-galactopyranosyl)oxy]pentanamido}propyl)amino]-3-oxopropoxy}methyl)-5,11,18-trioxo-14-oxa-6,10,17-triazanonacosan-29-oyl}-4-hydroxypyrrolidin-2-yl]methyl hydrogen all–P–ambo-2′-deoxy-2′-fluoro-P-thioguanylyl-(3’→5′)-2′-O-methyl-P-thioguanylyl-(3’→5′)-2′-deoxy-2′-fluorouridylyl-(3’→5′)-2′-O-methyluridylyl-(3’→5′)-2′-deoxy-2′-fluoroadenylyl-(3’→5′)-2′-O-methyladenylyl-(3’→5′)-2′-deoxy-2′-fluorocytidylyl-(3’→5′)-2′-O-methyladenylyl-(3’→5′)-2′-deoxy-2′-fluorocytidylyl-(3’→5′)-2′-deoxy-2′-fluorocytidylyl-(3’→5′)-2′-deoxy-2′-fluoroadenylyl-(3’→5′)-2′-O-methyluridylyl-(3’→5′)-2′-deoxy-2′-fluorouridylyl-(3’→5′)-2′-O-methyluridylyl-(3’→5′)-2′-deoxy-2′-fluoroadenylyl-(3’→5′)-2′-O-methylcytidylyl-(3’→5′)-2′-deoxy-2′-fluorouridylyl-(3’→5′)-2′-O-methyluridylyl-(3’→5′)-2′-deoxy-2′-fluorocytidylyl-(3’→5′)-2′-O-methyladenylyl-(3’→5′)-2′-deoxy-2′-fluoro-3′-adenylate and all–P–ambo-2′-O-methyl-P-thiouridylyl-(3’→5′)-2′-deoxy-2′-fluoro-P-thiouridylyl-(3’→5′)-2′-O-methylguanylyl-(3’→5′)-2′-deoxy-2′-fluoroadenylyl-(3’→5′)-2′-O-methyladenylyl-(3’→5′)-2′-deoxy-2′-fluoroguanylyl-(3’→5′)-2′-O-methyluridylyl-(3’→5′)-2′-deoxy-2′-fluoroadenylyl-(3’→5′)-2′-O-methyladenylyl-(3’→5′)-2′-deoxy-2′-fluoroadenylyl-(3’→5′)-2′-O-methyluridylyl-(3’→5′)-2′-O-methylguanylyl-(3’→5′)-2′-O-methylguanylyl-(3’→5′)-2′-deoxy-2′-fluorouridylyl-(3’→5′)-2′-O-methylguanylyl-(3’→5′)-2′-deoxy-2′-fluorouridylyl-(3’→5′)-2′-O-methyluridylyl-(3’→5′)-2′-deoxy-2′-fluoroadenylyl-(3’→5′)-2′-O-methyladenylyl-(3’→5′)-2′-deoxy-2′-fluorocytidylyl-(3’→5′)-2′-O-methyl-P-thiocytidylyl-(3’→5′)-2′-O-methyl-P-thioadenylyl-(3’→5′)-2′-O-methylguanosine C520H636F21N175Na43O309P43S6  : 17193.39[1609016-97-8] Fitusiran, sold under the brand name Qfitlia, is a medication used for the treatment of hemophilia.[1] It is an antithrombin-directed small …