Anticipated Drug Approvals 2024

Drug discovery crystal ball gazing for the year ahead. And the hottest new prospects are discussed below.
We have 1 CDER (FDA) approval this year, an interesting start –

Zelsuvmi (berdazimer), a nitric oxide (NO) releasing agent for the treatment of molluscum contagiosum.
Berdazimer is a polymeric drug substance consisting of a polysiloxane backbone with covalently bound N-diazeniumdiolate NO donors. When exposed to a proton donor this promotes NO release via decomposition of the N-diazeniumdiolate.

But what are the hottest and ‘potentially’ most lucrative drug approvals on the horizon this year? Note – these drugs are not yet FDA approved.

Zolbetuximab, a chimeric IgG1 mAb that targets and binds to Claudin 18.2, for the treatment of gastric cancer.

Lifileucel, a tumor-infiltrating lymphocyte (TIL) therapy that’s used to treat patients with non-uveal melanoma that has spread to the brain.

Resmetirom, a thyroid hormone receptor β agonist for the treatment of non-alcoholic steatohepatitis (NASH).

Roluperidone, a 5-HT2A and σ2 receptor antagonist for the treatment of schizophrenia.

Sotatercept, an activin receptor type IIA-Fc fusion protein for the treatment of pulmonary arterial hypertension.

Vadadustat, an oral hypoxia-inducible factor prolyl-hydroxylase inhibitor for the treatment of symptomatic anemia associated with CKD.

Donanemab, a humanized IgG1 mAb targeted against an epitope at the N-terminal of a specific type of Aβ for the treatment of AD.

Patritumab deruxtecan, a HER3 directed ADC for the treatment of EGFRm NSCLC.

Tovorafenib, a CNS-penetrant type II RAF inhibitor for the treatment of RAF-altered pediatric low-grade gliomas.

Imetelstat, a specific telomerase inhibitor for the treatment of myelodysplastic syndromes (MDS) and myelofibrosis (MF).

Tarlatamab, a delta-like ligand 3 (DLL3) targeting Bispecific T-cell Engager (BiTE®) for the treatment of advanced SCLC.

Fidanacogene elaparvovec, a novel gene therapy that contains a bio-engineered adeno-associated virus (AAV) capsid and a high-activity variant of human coagulation Factor IX (FIX) gene for the treatment of hemophilia B.

Danicopan, an oral proximal, complement alternative pathway factor D (FD) inhibitor for the treatment of Paroxysmal nocturnal hemoglobinuria (PNH).

Crovalimab, a anti-C5 recycling mAb designed to block the complement system for the treatment of of Paroxysmal nocturnal hemoglobinuria (PNH).

Xanomeline-trospium (KarXT), an dual-drug fixed-dose combination of xanomeline and trospium, for the treatment of schizophrenia.

An exciting year for many new investigational gene therapies, more ground-breaking ADCs and further transformational neuroscience drugs for the treatment of AD and schizophrenia. And hope for patients.

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