Remibrutinib (trade name Rhapsido®) was approved by the U.S. FDA on September 30, 2025, for the treatment of adults with chronic spontaneous urticaria (CSU) who have an inadequate response to H1 antihistamines.
Seralutinib is a next-generation inhaled small-molecule tyrosine kinase inhibitor developed by Gossamer Bio and is currently in Phase 3 clinical trials for the treatment of pulmonary arterial hypertension (PAH).
AMG 193 (Anvumetostat, Figure 1) is an MTA-cooperative PRMT5 inhibitor currently in clinical development for the treatment of MTAP-deleted cancers.
Afuresertib is an oral, ATP-competitive pan-AKT inhibitor originally from GSK and now developed by Laekna; currently in late-stage trials for solid tumors (e.g., HR+/HER2- breast cancer and mCRPC).
Enarodustat is an orally active hypoxia-inducible factor prolyl hydroxylase (PHD) inhibitor developed by Japan Tobacco for the treatment of renal anemia associated with chronic kidney disease (CKD).
Nerandomilast is a novel treatment option for adults with idiopathic pulmonary fibrosis (IPF), approved by the U.S. FDA on October 7, 2025.