FDA approved

Small Molecule: FDA approved in 2022

  • January 23, 2023
  • 2 mins read

A small molecule drug is a synthetic chemical derived from or inspired by natural products produced by bacteria, fungi, and plants. These drugs use biochemical processes to diagnose, treat, or prevent diseases. The Small molecules products are molecules with a molecular weight of < 900 Da. Small molecule drugs make up 90% of pharmaceutical drugs (like insulin, aspirin, and antihistamines). They also include biological molecules such as fatty acids, glucose, amino acids, and cholesterol and secondary metabolites for example lipids, glycosides, alkaloids, and natural phenols. Small molecules do not consist of larger molecules such as polysaccharides, proteins, and nucleic acids and can be involved in biological reactions as a product or substrate.

FDA-approved small molecule in 2022

The FDA approved the new innovator drug for more treatment options in 2022, including small molecule drugs. Regarding the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) provides drug developers with the necessary study design elements and other data needed in the drug application to support a complete and comprehensive assessment. To do so, CDER relies on its understanding of the science used to create new products, testing and manufacturing procedures, and the diseases and conditions that new products are designed to treat.

The list of small molecule drugs approved are:

Pharmaceutical company Name Active Ingredient Diseases
Pifzer Cibinquo Eczema
Mirati Krazati Non-small cell lung cancer
Polarean Xenoview MRI technique
CTI Biopharma Vonjo Myelofibrosis
Dermavant Vtama Plaque psoriasis
Mallinckrodt Terlivaz Improve kidney function
Rigel Rezlidhia Acute myeloid leukemia
Marinus Ztalmy Seizures
Phantom pharmaceuticals Voquezna Halicobacter pylori infection
Guerbet Elucirem MRI contrast agent
Amylyx Relyvrio Central Nervous System
Bristol Myers Squibb Sotyktu Plaque psoriasis
Taiho Oncology Lytgobi Bile duct cancer
Novartis Pluvicto Prostate cancer
Santen Omionti Glaucoma
Gilead Sunlenca HIV
Mycovia Pharmaceuticals Vivijoa Vulvovaginal candidiasis
Lilly Monjaro Blood sugar control
Idorsia Quviviq Insomania
Agios Pyrukynd Hemolytic anemia


Reference: https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2022