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New Drug Applications

The New Drug Application (NDA) is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the United States.
The purpose of a NDA is to provide enough information to permit the FDA to reach the following key decisions

For more information on new drug applications, please visit the FDA's How drugs are developed and approved page.

Icotrokinra

Company: Johnson & Johnson
Treatment for: Plaque Psoriasis

Icotrokinra is an oral, selective antagonist of the interleukin-23 receptor in development for the treatment of moderate to severe plaque psoriasis.

Reproxalap

Company: Aldeyra Therapeutics, Inc.
Treatment for: Dry Eye Disease

Reproxalap is a first-in-class small-molecule modulator of RASP (reactive aldehyde species) in development for the treatment of signs and symptoms of dry eye disease.

Relacorilant

Company: Corcept Therapeutics Incorporated
Treatment for: Cushing's Syndrome, Ovarian Cancer

Relacorilant is a selective cortisol modulator in development for the treatment of patients with endogenous hypercortisolism (Cushing’s syndrome), and for the combination treatment patients with platinum-resistant ovarian cancer.

Deramiocel

Company: Capricor Therapeutics
Treatment for: Duchenne Muscular Dystrophy Cardiomyopathy

Deramiocel is an investigational cell therapy in development for the treatment of Duchenne muscular dystrophy cardiomyopathy.

Oxylanthanum carbonate

Company: Unicycive Therapeutics, Inc.
Treatment for: Hyperphosphatemia of Renal Failure

Oxylanthanum carbonate is a next-generation lanthanum-based phosphate binding agent in development for the treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis.

Cytisinicline

Company: Achieve Life Sciences, Inc.
Treatment for: Smoking Cessation

Cytisinicline is a nicotinic acetylcholine receptor partial agonist in development as a treatment of nicotine dependence for smoking cessation in adults.

Ekterly (sebetralstat) Tablets

Company: KalVista Pharmaceuticals, Inc.
Treatment for: Hereditary Angioedema

Ekterly (sebetralstat) is an oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema attacks in adults and pediatric patients aged 12 years and older.

Brimochol PF (brimonidine tartrate and carbachol) Ophthalmic Solution

Company: Tenpoint Therapeutics, Ltd.
Treatment for: Presbyopia

Brimochol PF (brimonidine tartrate and carbachol) is an alpha-adrenergic agonist and cholinomimetic combination in development for the treatment of presbyopia.

Linerixibat

Company: GSK plc
Treatment for: Primary Biliary Cholangitis

Linerixibat is an ileal bile acid transporter (IBAT) inhibitor in development for the treatment of cholestatic pruritus in patients with primary biliary cholangitis.

Ziftomenib

Company: Kura Oncology, Inc. and Kyowa Kirin Co., Ltd.
Treatment for: Acute Myeloid Leukemia

Ziftomenib is an oral menin inhibitor in development for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a nucleophosmin 1 (NPM1) mutation.

Sevabertinib

Company: Bayer
Treatment for: Non Small Cell Lung Cancer

Sevabertinib is an oral, reversible tyrosine kinase inhibitor (TKI) in development for the treatment of HER2-mutant non-small cell lung cancer.

Elamipretide

Company: Stealth BioTherapeutics Inc.
Treatment for: Barth Syndrome

Elamipretide is a novel mitochondrial tetrapeptide in development for the treatment of Barth syndrome.

Patritumab deruxtecan

Company: Daiichi Sankyo and Merck
Treatment for: Non Small Cell Lung Cancer

Patritumab deruxtecan (HER3-DXd) is a first-in-class HER3 directed DXd antibody drug conjugate in development for the treatment of locally advanced or metastatic EGFR-mutated non-small cell lung cancer.

Sibeprenlimab

Company: Otsuka Pharmaceutical Co., Ltd.
Treatment for: Immunoglobulin A Nephropathy

Sibeprenlimab is an inhibitor of APRIL (A PRoliferation-Inducing Ligand) in development for the treatment of immunoglobulin A nephropathy.

Troriluzole

Company: Biohaven Ltd.
Treatment for: Spinocerebellar Ataxia

Troriluzole is a glutamate modulator in development for the treatment of adult patients with spinocerebellar ataxia.

Bysanti (milsaperidone)

Company: Vanda Pharmaceuticals Inc.
Treatment for: Bipolar Disorder, Schizophrenia

Bysanti (milsaperidone) is an atypical antipsychotic in development for the treatments of acute bipolar I disorder and schizophrenia.

Aficamten

Company: Cytokinetics, Incorporated
Treatment for: Hypertrophic Cardiomyopathy

Aficamten is a selective, small molecule cardiac myosin inhibitor in development for the treatment of obstructive hypertrophic cardiomyopathy.

Ensitrelvir

Company: Shionogi & Co., Ltd.
Treatment for: Post-Exposure Prophylaxis of COVID-19

Ensitrelvir is a 3CL protease inhibitor antiviral in development for post-exposure prophylaxis of COVID-19.

Cardamyst (etripamil) Nasal Spray

Company: Milestone Pharmaceuticals Inc.
Treatment for: Paroxysmal Supraventricular Tachycardia

Cardamyst (etripamil) is a novel calcium channel blocker nasal spray in development for the treatment of paroxysmal supraventricular tachycardia and atrial fibrillation with a rapid ventricular rate (AFib-RVR).

See also: Generic approvals, New drug approvals, Recent additions to Drugs.com, Alphabetical listing of all new drug applications, FDA approval process

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