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Samidorphan
go.drugbank.com/drugs/DB12543ApprovedInvestigational[A235638, A235643] Samidorphan was first approved as a variety of fixed-dose combination tablets with [olanzapine] by the FDA on May 28, 2021, and is currently marketed under the trademark LYBALVI™
Trofinetide
go.drugbank.com/drugs/DB06045Approved[A258438] Trofinetide was approved by the FDA on March 10, 2023, for the treatment of Rett syndrome,[L45718,L45748] which is an X-linked neurodevelopmental disorder characterized by a range of cognitive
Betaine
go.drugbank.com/drugs/DB06756ApprovedInvestigationalNutraceuticalThe FDA and EMA have approved the product Cystadane (betaine anhydrous, oral solution) for the treatment of homocystinuria,[L43105,L43115] and the EMA has approved the use of Amversio (betaine anhydrous
Lomitapide
go.drugbank.com/drugs/DB08827Approved[A7367] Lomitapide was first approved by the FDA in December 2012 and the EMA in July 2013 as an adjunct to a low-fat diet and other lipid-lowering treatments.[A275444, A275446]
Rezafungin
go.drugbank.com/drugs/DB16310ApprovedInvestigational[A258403] In March 2023, the FDA approved rezafungin for injection for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options.
Crinecerfont
go.drugbank.com/drugs/DB18518ApprovedInvestigational[A264818] Crinecerfont was approved by the FDA in December 2024 as an adjunct to glucocorticoid replacement in patients with CAH.[L51973,L51993]
Daraxonrasib
go.drugbank.com/drugs/DB22308ApprovedInvestigational[L64039,L64040] The FDA approved daraxonrasib on August 26, 2026 for the treatment of adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are
AdimrSC-2f
go.drugbank.com/drugs/DB16436InvestigationalThe AdimrSC-2f (SARS-CoV-2) vaccine is developed through Adimmune Corporation, the only influenza vaccine manufacturer with both EU GMP and US FDA certification in Asia[L30553].
Otilimab
go.drugbank.com/drugs/DB06303InvestigationalInvestigated for the treatment of osteoarthritis and rheumatoid arthritis (RA).
Pixantrone
go.drugbank.com/drugs/DB06193ApprovedWithdrawnBased on this uncertainty, in 2009, the FDA ultimately rejected Cell Therapeutic's initial application for accelerated approval for pixantrone use in relapsed or refractory NHL. … It is currently being tested in Phase III trials. [2] Although pixantrone has not yet received FDA approval in the United States, it has been granted conditional marketing approval by the European Union