Tag «FDA 2022»

Gadopiclenol

It’s only fair to share… Gadopiclenol ガドピクレノール; Formula C35H54N7O15. Gd CAS 933983-75-6 Mol weight 970.0912 FDA APPROVED 2022/9/21, Elucirem Diagnostic agent (MR imaging), WHO 10744, P 03277, UNII: S276568KOY EluciremTM; G03277; P03277; VUEWAY (alpha3,alpha6,alpha9-Tris(3-((2,3-dihydroxypropyl)amino)-3-oxopropyl)-3,6,9,15-tetraazabicyclo(9.3.1)pentadeca-1(15),11,13-triene-3,6,9-triacetato(3-)-kappaN3,kappaN6,kappaN9,kappaN15,kappaO3,kappaO6,kappaO9)gadolinium OriginatorGuerbet ClassDiagnostic agents; Gadolinium-containing contrast agents; Macrocyclic compounds; Propylamines; Pyridines Mechanism of ActionMagnetic resonance imaging enhancers RegisteredCNS disorders Phase IIIUnspecified Phase IILiver cancer 21 Sep …

Eflapegrastim

It’s only fair to share…   Eflapegrastim エフラペグラスチム; Molecular Formula C15-H28-N2-O6(C2-H4-O)n Molecular Weight 376.4468 Formula C3070H4764N806O927S23.(C2H4O)n UNII: UT99UG9QJX HM10460A SPI-2012 HNK460 Reducing neutropenia and the incidence of infecton in patients with cancer (2S)-1-{3-[2-(3-{[(1S,2R)-1-carboxy-2-hydroxypropyl]amino}propoxy)ethoxy]propyl}pyrrolidine-2-carboxylic acid APPROVED FDA 2022/9/9, Rolvedon CAS: 1384099-30-2 LAPS-GCSF, ROLONTIS Antineutropenic, Leukocyte growth factor Poly(oxy-1,2-ethanediyl), α-hydro-ω-hydroxy-, 1-ether with immunoglobulin G4 [1-[1-(3-hydroxypropyl)proline]] (human Fc fragment), (3→3′)–disulfide with immunoglobulin G4 …

Terlipressin acetate

It’s only fair to share…   Terlipressin acetate テルリプレシン酢酸塩 C52H74N16O15S2. (C2H4O2)x CAS:  914453-96-6 ACETATEFREE  FORM 14636-12-5 Terlipressin acetate (JAN); Heamopressin (TN); Terlivaz (TN) Cardiovascular agent Antidiuretic, Vasoconstrictor, Arginine vasopressin receptor agonist USFDA APPROVED 2022/9/14 An inactive peptide prodrug that is slowly converted in the body to lypressin. It is used to control bleeding of ESOPHAGEAL VARICES and …

Betibeglogene autotemcel

It’s only fair to share…   Betibeglogene autotemcel ベチベグロゲンアウトテムセル 2022/8/17, FDA APPROVED Zynteglo Cellular therapy product Treatment of betathalassemia BB305 LVV, bb 1111 BB305 transduced SCD CD34+ HSCs bb1111 LentiGlobin BB305 LVV-transduced autologous SCD CD34+ HSCs bb1111 LentiGlobin drug product for SCD LentiGlobin drug product for sickle cell disease LentiGlobin for SCD bb1111 Betibeglogene autotemcel, sold under …

Spesolimab

It’s only fair to share… (Heavy chain) QVQLVQSGAE VKKPGASVKV SCKASGYSFT SSWIHWVKQA PGQGLEWMGE INPGNVRTNY NENFRNKVTM TVDTSISTAY MELSRLRSDD TAVYYCTVVF YGEPYFPYWG QGTLVTVSSA STKGPSVFPL APSSKSTSGG TAALGCLVKD YFPEPVTVSW NSGALTSGVH TFPAVLQSSG LYSLSSVVTV PSSSLGTQTY ICNVNHKPSN TKVDKRVEPK SCDKTHTCPP CPAPEAAGGP SVFLFPPKPK DTLMISRTPE VTCVVVDVSH EDPEVKFNWY VDGVEVHNAK TKPREEQYNS TYRVVSVLTV LHQDWLNGKE YKCKVSNKAL PAPIEKTISK AKGQPREPQV YTLPPSREEM TKNQVSLTCL VKGFYPSDIA VEWESNGQPE NNYKTTPPVL DSDGSFFLYS KLTVDKSRWQ QGNVFSCSVM HEALHNHYTQ KSLSLSPGK (Light chain) QIVLTQSPGT …

Vutrisiran sodium, ALN 65492, Votrisiran

It’s only fair to share… RNA, (Um-sp-(2′-deoxy-2′-fluoro)C-sp-Um-Um-Gm-(2′-deoxy-2′-fluoro)G-Um-Um-(2′-deoxy-2′-fluoro)A-Cm-Am-Um-Gm-(2′-deoxy-2′-fluoro)A-Am-(2′-deoxy-2′-fluoro)A-Um-Cm-Cm-Cm-Am-sp-Um-sp-Cm), complex with RNA (Um-sp-Gm-sp-Gm-Gm-Am-Um-(2′-deoxy-2′-fluoro)U-Um-(2′-deoxy-2′-fluoro)C-(2′-deoxy-2′-fluoro)A-(2′-deoxy-2′-fluoro)U-Gm-Um-Am-Am-Cm-Cm-Am-Am-Gm-Am) 3′-[[(2S,4R)-1-[29-[[2-(acetylamino)-2-deoxy-β-D-galactopyranosyl]oxy]-14,14-bis[[3-[[3-[[5-[[2-(acetylamino)-2-deoxy-β-D-galactopyranosyl]oxy]-1-oxopentyl]amino]propyl]amino]-3-oxopropoxy]methyl]-1,12,19,25-tetraoxo-16-oxa-13,20,24-triazanonacos-1-yl]-4-hydroxy-2-pyrrolidinyl]methyl hydrogen phosphate] (1:1) Vutrisiran Sodium Nucleic Acid Sequence Sequence Length: 44, 23, 2113 a 9 c 8 g 14 umultistranded (2); modified Vutrisiran sodium ALN 65492 Votrisiran C530H672F9N171Na43O323P43S6 : 17289.77 [1867157-35-4 , Vutrisiran] Formula C530H672F9N171O323P43S6.43Na  OR C530H672F9N171Na43O323P43S6 CAS 1867157-35-4 , VURISIRAN Mol weight 17289.7661 FDA APPROVED, AMVUTTRA, 2022/6/13 …

Tirzepatide

It’s only fair to share… YXEGTFTSDY SIXLDKIAQK AFVQWLIAGG PSSGAPPPS Tirzepatide チルゼパチド LY3298176, Formula C225H348N48O68 CAS 2023788-19-2 Mol weight 4813.4514 FDA APPROVED 2022/5/13, Mounjaro Class Antidiabetic agent GLP-1 receptor agonist Efficacy Antidiabetic, Gastric inhibitory polypeptide receptor agonist, Glucagon-like peptide 1 (GLP-1) receptor agonist   Disease Type 2 diabetes mellitus L-Serinamide, L-tyrosyl-2-methylalanyl-L-α-glutamylglycyl-L-threonyl-L-phenylalanyl-L-threonyl-L-seryl-L-α-aspartyl-L-tyrosyl-L-seryl-L-isoleucyl-2-methylalanyl-L-leucyl-L-α-aspartyl-L-lysyl-L-isoleucyl-L-alanyl-L-glutaminyl-N6-[(22S)-22,42-dicarboxy-1,10,19,24-tetraoxo-3,6,12,15-tetraoxa-9,18,23-triazadotetracont-1-yl]-L-lysyl-L-alanyl-L-phenylalanyl-L-valyl-L-glutaminyl-L-tryptophyl-L-leucyl-L-isoleucyl-L-alanylglycylglycyl-L-prolyl-L-seryl-L-serylglycyl-L-alanyl-L-prolyl-L-prolyl-L-prolyl- Other Names L-Tyrosyl-2-methylalanyl-L-α-glutamylglycyl-L-threonyl-L-phenylalanyl-L-threonyl-L-seryl-L-α-aspartyl-L-tyrosyl-L-seryl-L-isoleucyl-2-methylalanyl-L-leucyl-L-α-aspartyl-L-lysyl-L-isoleucyl-L-alanyl-L-glutaminyl-N6-[(22S)-22,42-dicarboxy-1,10,19,24-tetraoxo-3,6,12,15-tetraoxa-9,18,23-triazadotetracont-1-yl]-L-lysyl-L-alanyl-L-phenylalanyl-L-valyl-L-glutaminyl-L-tryptophyl-L-leucyl-L-isoleucyl-L-alanylglycylglycyl-L-prolyl-L-seryl-L-serylglycyl-L-alanyl-L-prolyl-L-prolyl-L-prolyl-L-serinamide Tirzepatide is an agonist of human …

Lutetium Lu 177 vipivotide tetraxetan

It’s only fair to share… Lutetium Lu 177 vipivotide tetraxetan FDA APPROVED 2022/3/23, Pluvicto To treat prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer following other therapies Formula C49H65N9O16. Lu. 3H CAS 1703749-62-5 Mol weight 1214.0819 Antineoplastic, Radioactive agent   Disease Prostate cancer (PSMA positive) ルテチウム(177Lu)ビピボチドテトラキセタン; UNII-G6UF363ECX, WHO 11429 G6UF363ECX 177Lu-Psma-617 Vipivotide tetraxetan Lu-177 177Lu-Labeled PSMA-617 2-[4-[2-[[4-[[(2S)-1-[[(5S)-5-carboxy-5-[[(1S)-1,3-dicarboxypropyl]carbamoylamino]pentyl]amino]-3-naphthalen-2-yl-1-oxopropan-2-yl]carbamoyl]cyclohexyl]methylamino]-2-oxoethyl]-7,10-bis(carboxylatomethyl)-1,4,7,10-tetrazacyclododec-1-yl]acetate;lutetium-177(3+) (177Lu)Lutetium 2,2′,2′‘-[10-(2-{[(trans-4-{[(2S)-1-{[(5S)-5-carboxy-5-({[(1S)-1,3-dicarboxypropyl]carbamoyl}amino)pentyl]amino}-3-(2-naphthyl)-1-oxo-2-propanyl]carbamoyl}cyclohexyl)methyl]amino}-2- oxoethyl)-1,4,7,10-tetraazacyclododecane-1,4,7-triyl]triacetate …

Ganaxolone

It’s only fair to share… Ganaxolone Molecular FormulaC22H36O2 Average mass332.520 Da (3a,5a)-3-Hydroxy-3-methylpregnan-20-one (3α,5α)-3-Hydroxy-3-methylpregnan-20-one 38398-32-2 [RN] 3α-hydroxy-3β-methyl-5α-pregnan-20-one 7476 CCD-1042 FDA APPROVED 3/18/2022, Ztalmy To treat seizures in cyclin-dependent kinase-like 5 deficiency disorder Ganaxolone, sold under the brand name Ztalmy, is a medication used to treat seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD).[1][2] Ganaxolone was approved for medical use in …

Ciltacabtagene autoleucel

It’s only fair to share… Ciltacabtagene autoleucel FDA APPROVED, 2022/2/28,  Carvykti   Treatment of multiple myeloma   JNJ-68284528 LCAR-B38M CAR-T cells   Ciltacabtagene autoleucel is a BCMA-directed CAR T-cell therapy used in the treatment of relapsed or refractory multiple myeloma in previously treated patients. U.S. FDA Approves CARVYKTI™ (ciltacabtagene autoleucel), Janssen’s First Cell Therapy, a BCMA-Directed CAR-T …