Category «FDA 2025»

ATRASENTAN

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 Atrasentan hydrochloride E4G31X93ZA 195733-43-8 IJFUJIFSUKPWCZ-SQMFDTLJSA-N …

Taletrectinib

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, is an anti-cancer medication used for the …

Nerandomilast

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 of phosphodiesterase 4B (PDE4B) and …

ETRIPAMIL

ETRIPAMIL CAS 1593673-23-4 AS ACETATE 512.64 CAS 2891832-59-8 HCL SALT 2560549-35-9 WeightAverage: 452.595Monoisotopic: 452.267507647 Chemical FormulaC27H36N2O4 12/12/2025, FDA 2025, APPROVALS 2025 Benzoic acid, 3-[2-[[(4S)-4-cyano-4-(3,4-dimethoxyphenyl)-5-methylhexyl]methylamino]ethyl]-, methyl ester methyl 3-[2-[[(4S)-4-cyano-4-(3,4-dimethoxyphenyl)-5-methylhexyl]-methylamino]ethyl]benzoate Etripamil has been used in trials studying the treatment of Paroxysmal Supraventricular Tachycardia (PSVT). Etripamil (MSP-2017) is a short-acting, L-type calcium-channel antagonist. Etripamil inhibits calcium influx through slow calcium …

Fitusiran

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 interfering ribonucleic acid.[1] It is given …

Gepotidacin

Gepotidacin CAS 1075236-89-3 GSK-2140944GSK2140944 WeightAverage: 448.527Monoisotopic: 448.222288786 Chemical FormulaC24H28N6O3(3R)-3-({4-[({2H,3H,4H-pyrano[2,3-c]pyridin-6-yl}methyl)amino]piperidin-1-yl}methyl)-1,4,7-triazatricyclo[6.3.1.0^{4,12}]dodeca-6,8(12),9-triene-5,11-dione FDA APPROVED 3/25/2025,Blujepa, To treat uncomplicated urinary tract infections Ingredient UNII CAS InChI Key Gepotidacin hydrochloride 30Z5B7ACV6 1075235-46-9 DPAHPKBTWARMFG-FSRHSHDFSA-N Gepotidacin mesylate 5P7X0H2O6B 1624306-20-2 MTLHHQWYERWLIX-RGFWRHHQSA-N Gepotidacin, sold under the brand name Blujepa, is an antibiotic medication used for the treatment of urinary tract infection.[1] Gepotidacin is a triazaacenaphthylene bacterial type II topoisomerase inhibitor.[1][2] It …

Vimseltinib

Vimseltinib 1628606-05-2 DCC-3014 2/14/2025 FDA APPROVED, Romvimza 3-methyl-5-[6-methyl-5-[2-(1-methylpyrazol-4-yl)pyridin-4-yl]oxypyridin-2-yl]-2-(propan-2-ylamino)pyrimidin-4-one C23H25N7O2, 431.5 To treat symptomatic tenosynovial giant cell tumor for which surgical resection will potentially cause worsening functional limitation or severe morbidity Vimseltinib is an orally bioavailable inhibitor of the tyrosine kinase receptor colony stimulating factor 1 receptor (CSF1R; CSF-1R; C-FMS; CD115; M-CSFR), with potential antineoplastic, macrophage checkpoint-inhibitory and …

TREOSULFAN

TREOSULFAN C6H14O8S2 MW 278.29 FDA APPROVED 1/21/2025 Grafapex CAS 299-75-2 Treosulfan299-75-2TreosulphanOvastatTreosulfano NSC-39069 [(2S,3S)-2,3-dihydroxy-4-methylsulfonyloxybutyl] methanesulfonate Trecondi, Treosulfan was authorized for medical use in the European Union in June 2019 For use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation for acute myeloid leukemia and myelodysplastic syndrome Treosulfan, sold under the …

Suzetrigine

Suzetrigine CAS 2649467-58-1 WeightAverage: 473.4Monoisotopic: 473.137396951Chemical FormulaC21H20F5N3O4 FDA 1/30/2025, Journavx To treat moderate to severe acute painPress Release Suzetrigine, sold under the brand name Journavx, is a medication used for the management of pain.[1][2] It is a non-opioid, small-molecule analgesic that works as a selective inhibitor of Nav1.8-dependent pain-signaling pathways in the peripheral nervous system,[3][4] avoiding the addictive potential of opioids. Suzetrigine is taken by mouth.[1] The most common adverse reactions include …

MIRDAMETINIB

MIRDAMETINIB 391210-10-9 Chemical Formula: C16H14F3IN2O4 Molecular Weight: 482.19 PD0325901; PD 0325901; PD-325901; mirdametinib FDA APPROVED 2/11/2025, Gomekli, To treat neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection IUPAC/Chemical Name: (R)-N-(2,3-dihydroxypropoxy)-3,4-difluoro-2-((2-fluoro-4-iodophenyl)amino)benzamide SpringWorks Therapeutics (a spin out of Pfizer ) is developing mirdametinib, a second-generation, non-ATP competitive, allosteric MEK1 and MEK2 inhibitor derived …