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BioWorld - Saturday, December 27, 2025
Home » Topics » Regulatory » IND

IND
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Influenza virus
Infection

Via Nova Therapeutics receives FDA clearance of IND for influenza A nucleoprotein inhibitor

Sep. 22, 2023
Via Nova Therapeutics Inc. has received clearance of its IND application from the FDA for its influenza A nucleoprotein inhibitor, VNT-101. The novel investigational small molecule is directed against a novel target, the influenza A nucleoprotein, and is being developed for treatment of seasonal influenza A infection.
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Gastrointestinal

Hepagene’s THR-β agonist HPG-7233 cleared to enter clinic for NASH and dyslipidemia

Sep. 21, 2023
Hepagene Therapeutics Inc. has received FDA clearance of its IND application for HPG-7233 for the treatment of patients with nonalcoholic steatohepatitis (NASH) and dyslipidemia.
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Mantle cell lymphoma
Cancer

Lantern’s LP-284 cleared by FDA to enter clinic for NHL

Sep. 19, 2023
Lantern Pharma Inc. has received FDA clearance of its IND application for LP-284, being developed for the treatment of relapsed or refractory non-Hodgkin lymphoma (NHL), including mantle cell lymphoma, double hit lymphoma and other high-grade B-cell lymphomas. Enrollment in a first-in-human phase I trial is expected to begin during the fourth quarter of this year. 
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Neurology/Psychiatric

Lapix’s TIM-3/4 receptor agonist cleared to enter clinic for multiple sclerosis

Sep. 19, 2023
Lapix Therapeutics Inc. has received IND clearance from the FDA to initiate a phase I trial of its first-in-class, immune tolerance restoration small molecule, LPX-TI641, for the treatment of multiple sclerosis (MS).
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Antibiotic resistant bacteria inside a biofilm
Infection

Contrafect files IND for CF-370 for hospital-acquired and ventilator-associated bacterial pneumonias

Sep. 18, 2023
Contrafect Corp. has submitted an IND application to the FDA for its intravenous antibacterial agent, CF-370, for treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.
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Drug capsule spilling onto brain
Neurology/Psychiatric

FDA clears IND for ADEL-Y01 for Alzheimer’s disease

Sep. 15, 2023
The FDA has cleared an IND application for ADEL-Y01, being jointly developed by Oscotec Inc. and Adel Inc., for the treatment of Alzheimer’s disease. A phase Ia/b study will include healthy volunteers, and participants with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease.
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Pipet, test tubes, chemical structure
Cancer

Eikon Therapeutics advances preclinical pipeline

Sep. 12, 2023
Eikon Therapeutics Inc. has received IND clearance from the FDA to initiate phase I studies with IMP-1734, a highly selective poly(ADP-ribose) polymerase 1 (PARP-1) inhibitor developed in partnership with Impact Therapeutics Inc.
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Art concept for tumor
Cancer

Carrick receives US IND approval for CDK12/13 inhibitor CT-7439 for advanced solid tumors

Sep. 8, 2023
Carrick Therapeutics Ltd. has received FDA clearance of its IND application for CT-7439, a novel cyclin dependent kinase 12/13 (CDK12/13) inhibitor.
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Limb exam
Neurology/Psychiatric

Pepgen’s PGN-EDODM1 cleared to enter clinic in Canada for DM1, receives US orphan drug designation

Sep. 7, 2023
Pepgen Inc. has received a no objection letter from Health Canada for its clinical trial application (CTA) to initiate a phase I study of PGN-EDODM1 in patients with myotonic dystrophy type 1 (DM1). Initial data from the study are expected next year.
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Cancer

Tango’s USP1 inhibitor TNG-348 cleared to enter clinic for BRCA1/2 mutant and other HRD+ cancers

Sep. 7, 2023
Tango Therapeutics Inc. has received FDA clearance of its IND application for TNG-348...
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