This resource page compiles all of the 2022 drug approvals and our articles on the novel small molecule and large molecule drugs approved by the FDA. You can find the structures and read more about each group in the articles below. (Last updated Apr. 4, 2022)
January 2022 FDA Novel Drug Approvals
Mitapivat – An Allosteric PKR Kinase Activator
February 2022 FDA Novel Drug Approvals
March 2022 FDA Novel Drug Approvals
April 2022 FDA Novel Drug Approvals
List of 2022 Drug Approvals (Novel Drugs)
Novel small molecule FDA drug approvals of 2022:
- Quviviq (daridorexant): Oral dual orexin receptor blocker (OX1/OX2); for insomnia in adults; antagonizes orexin neuropeptide mediated wakefulness.
- CibinqoTM (abrocitinib): Oral JAK1-selective inhibitor (9-28x); 100 or 200 mg QD; for refractory atopic dermatitis in adults; reduces inflammatory cytokines.
- Pyrukynd (mitapivat): An oral pyruvate kinase activator approved for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency.
- Vonjo (pacritinib): An oral (200 mg BID) JAK2/IRAK1 kinase inhibitor with selectivity over JAK1 for treatment of myelofibrosis
- Ztalmy® (ganaxolone): An oral GABA-A receptor modulator to treat seizures in cyclin-dependent kinase-like 5 deficiency disorder
- PluvictoTM (lutetium Lu 177 vipivotide tetraxetan): An injectable, therapeutically active radioligand to treat prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer following other therapies
- Camzyos (mavacamten), an oral cardiac myosin inhibitor
- Vivjoy (oteseconazole), an oral antifungal
Novel large molecule FDA drug approvals of 2022:
- Kimmtrak® (tebentafusp): Injectable bispecific gp100 peptide-HLA-directed CD3 T cell engager; for treating patients with HLA-A*02:01 positive patients with unresectable or metastatic uveal melanoma; induces lysis of uveal cancer cells by stimulating T cells to release inflammatory cytokines and cytolytic proteins.
- VabysmoTM (faricimab): Injectable VEGF and Ang-2 inhibitor; for treating nAMD and DME; inhibits neovascularization and promotes vascular stability.
- Enjaymo (sutimlimab): An injectable classical complement pathway inhibitor (IgG mAb targeting C1s) approved for decreasing red blood cell (RBC) transfusions in adults with cold agglutinin disease (CAD).
- OpdualagTM (nivolumab and relatlimab): IV combination of nivolumab (PD-1 blocking antibody) and the novel relatlimab (LAG-3 blocking antibody) to treat unresectable or metastatic melanoma
