Category «APPROVALS 2026»

Zidesamtinib

Zidesamtinib CAS 2739829-00-4 MF C22H22FN7O MW419.5 g/mol (19R)-3-ethyl-16-fluoro-10,19-dimethyl-20-oxa-3,4,9,10,11,23-hexazapentacyclo[19.3.1.02,6.08,12.013,18]pentacosa-1(25),2(6),4,8,11,13(18),14,16,21,23-decaen-22-amine To treat adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer after receiving a ROS1 kinase inhibitor FDA 2026, APPROVALS 2026, Jideytro, NVL-520, NUV-520, NU-520, NVL 520, NUV 520, NU 520, MX5KQV5XHC Zidesamtinib (sold under the brand name Jideytro) is an oral, highly selective, next-generation kinase …

Gedatolisib

Gedatolisib Approvals 3026, FDA 2026, 7/14/2026, Revtorpyk PF-05212384; PF-5212384; PKI-587CAS 1197160-78-3Chemical Formula: C32H41N9O4Molecular Weight: 615.721-(4-{[4-(Dimethylamino)-1-piperidinyl]carbonyl}phenyl)-3-{4-[4,6-di(4-morpholinyl)-1,3,5-triazin-2-yl]phenyl}urea3-{4-[bis(morpholin-4-yl)-1,3,5-triazin-2-yl]phenyl}-1-{4-[4-(dimethylamino)piperidine-1-carbonyl]phenyl}ureaN-[4-[[4-(Dimethylamino)-1-piperidinyl]carbonyl]phenyl]-N’-[4-[4,6-di(4-morpholinyl)-1,3,5-triazin-2-yl]phenyl]ureaгедатолисиб [Russian] [INN]غيداتوليسيب [Arabic] [INN]吉达利塞 [Chinese] [INN] 1-(4-(4-(Dimethylamino)piperidine-1-carbonyl)phenyl)-3-(4-(4,6-dimorpholino-1,3,5-triazin-2-yl)phenyl)urea Urea, N-[4-[[4-(dimethylamino)-1-piperidinyl]carbonyl]phenyl]-N’-[4-(4,6-di-4-morpholinyl-1,3,5-triazin-2-yl)phenyl]- 96265TNH2R In combination with fulvestran, to treat hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line …

Gadoquatrane

Gadoquatrane CAS2048221-65-2MW2579.0 g/mol FDA 2026, APPROVALS 2026, Ambelvist, OZG7J613HK, BAY-1747846, BAY 1747846 2-[4,10-bis(carboxylatomethyl)-7-[1-oxo-1-[[2-oxo-2-[[3-[[2-[2-[4,7,10-tris(carboxylatomethyl)-1,4,7,10-tetrazacyclododec-1-yl]propanoylamino]acetyl]amino]-2,2-bis[[[2-[2-[4,7,10-tris(carboxylatomethyl)-1,4,7,10-tetrazacyclododec-1-yl]propanoylamino]acetyl]amino]methyl]propyl]amino]ethyl]amino]propan-2-yl]-1,4,7,10-tetrazacyclododec-1-yl]acetate;tetrakis(gadolinium(3+)) TETRAGADOLINIUM (4,10-BIS(CARBOXYLATOMETHYL)-7-(3,6,12,15-TETRAOXO-16-(4,7,10-TRIS-(CARBOXYLATOMETHYL)-1,4,7,10-TETRAAZACYCLODODECAN-1-YL)-9,9-BIS(((((2-(4,7,10-TRIS-(CARBOXYLATOMETHYL)-1,4,7,10-TETRAAZACYCLODODECAN-1-YL)PROPANOYL)AMINO)ACETYL)-AMINO)METHYL)-4,7,11,14-TETRAAZAHEPTADECAN-2-YL)-1,4,7,10-TETRAAZACYCLODODECAN-1-YL)ACETATE To detect and visualize lesions with abnormal vascularity, in conjunction with MRI Gadoquatrane (marketed as AMBELVIST®) is a low-dose, macrocyclic gadolinium-based contrast agent (GBCA) developed by Bayer for use in magnetic resonance imaging (MRI). It is designed to enhance the visualization …

Sonrotoclax

Sonrotoclax CAS 2383086-06-2 MW 890.1 g/mol, MFC49H59N7O7S FDA APPROVED 5/13/2026, Beqalzi, APPROVALS 2026, BGB-11417, BGB 11417, 30R67U9KYS N-[4-[(4-hydroxy-4-methylcyclohexyl)methylamino]-3-nitrophenyl]sulfonyl-4-[2-[(2S)-2-(2-propan-2-ylphenyl)pyrrolidin-1-yl]-7-azaspiro[3.5]nonan-7-yl]-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide To treat adults with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase inhibitor Sonrotoclax is a potent, orally active Bcl2 inhibitor. Sonrotoclax has effective cell killing effect against a …

Vepdegestrant

Vepdegestrant CAS 2229711-08-2 MW 723.9 g/mol, C45H49N5O4 (3S)-3-[6-[4-[[1-[4-[(1R,2S)-6-hydroxy-2-phenyl-1,2,3,4-tetrahydronaphthalen-1-yl]phenyl]piperidin-4-yl]methyl]piperazin-1-yl]-3-oxo-1H-isoindol-2-yl]piperidine-2,6-dione 5/1/2026, FDA 2026, APROVALS 2026, Veppanu, ARV 471, WC1U3R1YMI, PF 07850327 To treat estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy On May 1, 2026, the FDA approved vepdegestrant (Veppanu), a …

Navepegritide

Navepegritide Cas 2413551-27-4 Molecular Formula: C₂₃₁H₃₈₆N₆₄O₆₇S₅ + (C₂H₄O)₄ₙ (approx. 45 kDa), 1804.0 g/mol MOLECULAR FORMULA C231H386N64O67S5 + (C2H4O)4nMOLECULAR WEIGHT approx. 45 kDa The structure of navepegritide (YUVIWEL®) is built using a “prodrug” design. It is not a simple small molecule, but rather a complex conjugate consisting of three distinct components designed to release the active drug slowly over time. 1. …

Oveporexton

Oveporexton APPROVED FDA 2026, To treat narcolepsy type 1 CAS 2460722-04-5 MF C23H25F5N2O4S MW 520.5 N-[(2S,3R)-2-[[3-(3,5-difluorophenyl)-2-fluorophenyl]methyl]-4,4-difluoro-1-(2-hydroxy-2-methylpropanoyl)pyrrolidin-3-yl]ethanesulfonamide N-[(2S,3R)-1-(2-ヒドロキシ-2-メチルプロピオニル)-2-(2,3′,5′-トリフルオロビフェニル-3-イルメチル)-4,4-ジフルオロピロリジン-3-イル]エタンスルホンアミド ETHANESULFONAMIDE, N-((2S,3R)-4,4-DIFLUORO-1-(2-HYDROXY-2-METHYL-1-OXOPROPYL)-2-((2,3′,5′-TRIFLUORO(1,1′-BIPHENYL)-3-YL)METHYL)-3-PYRROLIDINYL)- N-[(2S,3R)-2-[[3-(3,5-difluorophenyl)-2-fluorophenyl]methyl]-4,4-difluoro-1-(2-hydroxy-2-methylpropanoyl)pyrrolidin-3-yl]ethanesulfonamide N-{(2S,3R)-4,4-difluoro-1-(2-hydroxy-2-methylpropanoyl)-2-[(2,3′,5′-trifluoro-[1,1′-biphenyl]-3-yl)methyl]pyrrolidin-3-yl}ethane-1-sulfonamideorexin type 2 receptor agonist, TAK-861, TAK 861, 59MF6P2ATF Oveporexton is a small molecule drug. The usage of the INN stem ‘-orexton’ in the name indicates that Oveporexton is a orexin receptor agonist. Oveporexton has …

Milsaperidone

Milsaperidone CAS 501373-88-2 C24H29FN2O4 MW 428.50 FDA APPROVED 2/20/2026, Bysanti, To treat schizophrenia and to treat manic or mixed episodes associated with bipolar I disorder (1S)-1-[4-[3-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]propoxy]-3-methoxyphenyl]ethanol 7SV1ZOG031, P-88-8991, (-)-, (S)-Hydroxy Iloperidone, P-88, VHX 869, VHX-896 Milsaperidone (INNTooltip International Nonproprietary Name, USANTooltip United States Adopted Name), also known by its developmental code name VHX-896 and its tentative brand name Bysanti, is …

Copper histidinate

Copper histidinate CAS 12561-67-0 AND 13870-80-9 MF C12H16CuN6O4 FDA 2026, JAN/12/26, Zycubo, To treat Menkes disease, APPROVALS 2026, 9078K3MO9U, MN 88, CUTX 101 copper bis((2S)-2-amino-3-(1H-imidazol-5-yl)propanoate) Copper histidinate, sold under the brand name Zycubo, is a medication used for the treatment of Menkes disease.[1] Copper histidinate is a copper replacement therapy given by subcutaneous injection.[1][2] The most common side effects …

Olorigliflozin, Rongliflozin

Rongliflozin Olorigliflozin, 6FP3NST6ZQ, DJT1116PG Cas 2035989-50-3 450.9 g/mol, C23H27ClO7 1-C-{4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl}-1-O,5-Cmethylene-D-glycero-α-D-gluco-heptopyranosesodium glucose co-transporter inhibitor, antihyperglycaemic, (1R,2S,3S,4R,5S)-5-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-1-[(1R)-1-hydroxyethyl]-6,8-dioxabicyclo[3.2.1]octane-2,3,4-triol Rongliflozin 화학구조 CAS No. : 2648020-91-9 MW 602.55 MF C23H27ClO7.C5H7NO3.5/4H2O HEC Pharma announced that its independently developed Olorigliflozin (previously known as rongliflozin pyroglutamate) capsules, has been approved for marketing by the China NMPA. It can be used as a monotherapy or in combination …