Drug Approvals International – Page 81 – All about Drugs Live by Dr Anthony Melvin Crasto

REPROXALAP

REPROXALAP レプロキサラップ; ADX-102 2-(3-amino-6-chloroquinolin-2-yl)propan-2-ol C12H13ClN2O, 236.7 g/mol CAS 916056-79-6 UNII-F0GIZ22IJH 2-(3-amino-6-chloroquinolin-2-yl)propan-2-ol Phase 3 Clinical Aldeyra Therapeutics is developing reproxalap, which binds and traps free aldehydes, formulated using Captisol technology licensed from Ligand Pharmaceuticals as an eye drop formulation, for treating acute noninfectious anterior uveitis, allergic conjunctivitis and dry eye syndrome. PATENT product case, WO2006127945 , EU …

Lercanidipine hydrochloride,

Lercanidipine CAS Registry Number: 100427-26-7 CAS Name: 1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic acid 2-[(3,3-diphenylpropyl)methylamino]-1,1-dimethylethyl methyl ester Additional Names: methyl 1,1,N-trimethyl-N-(3,3-diphenylpropyl)-2-aminoethyl 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylate; methyl 1,1-dimethyl-2-[N-(3,3-diphenylpropyl)-N-methylamino]ethyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate; masnidipine Molecular Formula: C36H41N3O6 Molecular Weight: 611.73 Percent Composition: C 70.68%, H 6.76%, N 6.87%, O 15.69% Literature References: Dihydropyridine calcium channel blocker. Prepn: D. Nardi et al., EP 153016; eidem, US 4705797 (1985, 1987 both to Recordati). Pharmacology: G. Bianchi et al., Pharmacol. Res. 21, 193 (1989). Clinical evaluation in hypertension: E. …

Spinosad

Spinosad Spinosyn A: The chemical name is: 1H-as-Indaceno[3,2- d]oxacyclododecin-7,a5-dione, 2-[(6-deoxy-2,3,4-tri-O-methyl-alphaL-mannopyranosyl)oxy]-13-[[2R,5S,6R)-5-(dimethylamino) tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-metyl-, (2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)- Spinosyn D: The chemical name is: 1H-as-Indaceno[3,2- d]oxacyclododecin-7,15-dione, 2-[(6-deoxy-2,3,4-tri-O-methyl-alphaL-mannopyranosyl)oxy]-13-[[2R,5S,6R)-5-(dimethylamino) tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimetyl-, (2S,3aSR,5aS,5bS,9S,13S,14R,16aS,16bS)- 168316-95-8 Molecular FormulaC83H132N2O20 Average mass1477.938 Da Comfortis Conserve EC 434-300-1 Natroba NaturaLyte Spinosad Tracer Tracer Naturalyte UNII-XPA88EAP6V XDE 105 Natroba (Spinosad) Suspension 0.9% ParaPro Pharma New Drug Application (NDA): 022408 appr 01/18/2011 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022408Orig1s000ChemR.pdf spinosad, …

Triheptanoin

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, rhabdomyolysis, and hepatomegaly.1,2 Complications in lc-FAOD …

MILVEXIAN

MILVEXIAN ミルベクシアン; Molecular Formula,C28-H23-Cl2-F2-N9-O2 Molecular Weight, 626.4441 BMS-986177, JNJ-70033093; JNJ-3093, WHO 11401 CAS 1802425-99-5 (5R,9S)-9-(4-(5-Chloro-2-(4-chloro-1H-1,2,3-triazol-1-yl)phenyl)-6-oxopyrimidin-1(6H)-yl)-21-(difluoromethyl)-5-methyl-21H-3-aza-1(4,2)-pyridina-2(5,4)-pyrazolacyclonaphan-4-one Prevention and Treatment of Thromboembolic Disorders Milvexian, also known as BMS-986177, is a blood coagulation factor XIa inhibitor.Bristol-Myers Squibb , in collaboration with Janssen , is developing milvexian (BMS-986177, JNJ-70033093; JNJ-3093), an antithrombotic factor XIa (FXIa) inhibitor, for the oral …

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 …

ENZALUTAMIDE

4-(6-chloro-1-oxo-3-thioxo-9,9a-dihydro-1H-imidazo[1,5-a]indol-2(3H)-yl)-2-(trifluoromethyl)-benzonitrile Drug Name： Enzalutamide Research Code： MDV-3100 Trade Name： Xtandi® MOA： Androgen receptor inhibitor Indication： Prostate cancer Status： Approved Company： Medivation (Originator) , Astellas Sales： $2,100.8 Million (Y2015); $1,247.3 Million (Y2014); $546 Million (Y2013); $148.8 Million (Y2012); ATC Code： L01 Approved Countries or AreaUpdate Date：2015-07-29 US EU JP Approval Date Approval Type Trade Name …

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, …

Tetrahydrobiopterin

Sapropterin Sapropterin dihydrochloride, Dapropterin dihydrochloride, R-THBP, 6R-BH4, SUN-0588, Phenoptin, Biopten, Biobuden, Bipten Approval:US: Dec’07, EU: Dec’08 INNOVATOR BIOMARIN IUPAC Name (6R)-2-amino-6-[(1R,2S)-1,2-dihydroxypropyl]-3,4,5,6,7,8-hexahydropteridin-4-one SMILES [H][C@@]1(CNC2=C(N1)C(=O)NC(N)=N2)[C@@H](O)[C@H](C)O сапроптерин [Russian] [INN] سابروبتيرين [INN] 沙丙蝶呤 [Chinese] [INN] 17528-72-2 27070-47-9 Sun 0588 6R-BH4 R-THBP Sapropterin Sapropterina sapropterinum Tetrahydrobiopterin Title: Sapropterin CAS Registry Number: 62989-33-7 CAS Name: (6R)-2-Amino-6-[(1R,2S)-1,2-dihydroxypropyl]-5,6,7,8-tetrahydro-4(1H)-pteridinone Additional Names: (6R)-L-erythro-tetrahydrobiopterin; dapropterin; R-THBP; 6R-BH4 Molecular Formula: C9H15N5O3 Molecular Weight: 241.25 Percent Composition: C 44.81%, H …