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Birch bark extract
go.drugbank.com/drugs/DB16536ApprovedInvestigational[L42390] Filsuvez was subsequently approved for the same indication by the US FDA in December 2023.
Belumosudil
go.drugbank.com/drugs/DB16703ApprovedInvestigational[A236644,L34759] Belumosudil was first approved by the FDA in July 2021, under the brand name Rezurock, for the treatment of chronic GVHD in patients who have tried and failed at least two prior lines
Xenon Xe-129
go.drugbank.com/drugs/DB17386ApprovedInvestigational[A255183] In December 2022, the FDA approved the use of hyperpolarized Xe-129 for use with MRI for the evaluation of lung ventilation.
Pegunigalsidase alfa
go.drugbank.com/drugs/DB14992ApprovedInvestigational[L46342,L46387] Later on, the FDA approved pegunigalsidase alfa for the treatment of adult patients with Fabry disease that same month.[L46432,L46437]
Zinc gluconate
go.drugbank.com/drugs/DB11248ApprovedInvestigationalVet approvedZinc gluconate is a generally recognized as safe (GRAS) substance by FDA [L2081].
Inclisiran
go.drugbank.com/drugs/DB14901ApprovedInvestigational[L28178] Inclisiran was later approved by the FDA on December 22, 2021, for the treatment of heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease in adults
Gantenerumab
go.drugbank.com/drugs/DB12034Investigational[A244705, A244710] These treatments include the related antibodies [aducanumab], which has been granted accelerated FDA approval, along with [bapineuzumab], [crenezumab], [donanemab], [lecanemab], and … Despite the clear association of Aβ aggregation with AD, treatments aimed at preventing Aβ aggregation or removing pre-existing Aβ plaques have shown little to no clinical benefit thus far and remain controversial
Tividenofusp alfa
go.drugbank.com/drugs/DB17628ApprovedInvestigationalDeveloped by Denali Therapeutics, tividenofusp alfa received FDA approval on March 25, 2026, under the accelerated approval pathway [L56097, L56099].
Clozapine
go.drugbank.com/drugs/DB00363ApprovedInvestigational[A256718] Clozapine was approved by the FDA in 1989 for treatment-resistant schizophrenia under the brand CLOZARIL.
Asciminib
go.drugbank.com/drugs/DB12597ApprovedInvestigational[L38995,A241055] Asciminib received FDA approval on October 29, 2021 (Scemblix, Novartis AG).[L39000]