Small Molecule FDA Novel Drug Approvals Increase by Over 50% in 2023
Small Molecule Drugs Continue to be Crucial in Advancing Healthcare with 34 New Approvals in 2023 Compared to 21 in 2022
The Food and Drug Administration (FDA) approved 55 new drugs in 2023, an increase of nearly 50% from the 37 approvals in 2022, the second highest number in the past 30 years [1].
34 out of the 55 approved new drugs are small molecules, representing 62% of the total. The growing number of small molecules from the previous years, corresponding to the 56% in 2021 (28 out of 50) and 57% in 2022 (21 out of 37), shows how this class of drugs continues to be crucial in advancing health care.
Oncology remains the therapeutic area with the highest percentage of approvals (24%), followed by neurology (16%), and infectious diseases and haematology (9%).
Availability in the Cambridge Structural Database
The Cambridge Structural Database (CSD) contains 8 of the 34 small molecule drugs approved by the FDA at the time of writing. These structures can be viewed using the CSD refcodes listed below.
Drug (brand name) – Bexagliflozin (Brenzavvy)
Bexagliflozin is a SGLT2 inhibitor used to improve glycaemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise [2]. CSD refcode: UVORAA.
Fezolinetant (Veozah)
Fezolinetant is a neurokinin 3 receptor antagonist used to treat moderate to severe hot flashes caused by menopause [2]. CSD refcode: PAHSID.
Sulbactam, durlobactam (Xacduro)
Xacduro consists of sulbactam, a drug structurally related to penicillin, and durlobactam. These are β-lactam antibacterial and β-lactamase inhibitors used to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex [2]. CSD refcodes for sulbactam: BAFVOT (penicillanic acid sulfone), BAFVOT01 (6,6-Dideutero-penicillanic acid sulfone).
Nirmatrelvir, ritonavir (Paxlovid)
Paxlovid contains nirmatrelvir and ritonavir which are SARS-CoV-2 main protease inhibitor and a CYP3A inhibitor. The drug is used to treat mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19 [2]. CSD refcodes for nirmatrelvir: ZIVMEA, ZIVMEA01. CSD refcodes for ritonavir: YIGPIO, YIGPIO01, YIGPIO02, YIGPIO03, YIGPIO04, YIGPIO05, YIGPIO06.
Sotagliflozin (Inpefa)
Sotagliflozin is a SGLT2 inhibitor used to treat heart failure [2]. CSD refcode: TEJGAT.
Vamorolone (Agamree)
Vamorolone is a corticosteroid used to treat Duchenne muscular dystrophy [2]. CSD refcode: SICZIQ.
Taurolidine, heparin (Defencath)
Defencath contains taurolidine and heparin which are a thiadiazinane antimicrobial and an anticoagulant. The drug is used to reduce the incidence of catheter-related bloodstream infections [2]. CSD refcode for taurolidine: HAHXOG.
Birch triterpenes (Filsuvez)
Birch triterpenes are used to treat wounds associated with dystrophic and junctional epidermolysis bullosa [2]. The CSD contains several birch triterpenes in their solvated and desolvated forms. Examples are: betulin hemihydrate, CSD refcode: VUTLOO; betulinic acid, CSD refcode: LIXQOA (propan-2-ol solvate); lupeol, CSD refcode: JOLBIW; oleanolic acid, CSD refcode: VUZVUI (ethanol solvate).
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