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Home » Topics » Regulatory » IND

IND
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Circode executives
Newco news

Circode applies circRNA to heart disease drug R&D, in vivo CAR T

July 11, 2025
By Marian (YoonJee) Chu
No Comments
Shanghai Circode Biomed Co. Ltd. is set to begin clinical trials of HM-2002, a circular RNA (circRNA)-based drug for ischemic heart disease, having gained IND clearance in China Jan. 10 and the U.S. on May 30, Circode CEO Chenxiang Tang recently told BioWorld.
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Illustration of diabetic foot ulcer, cross section of wound
Dermatologic

FDA clears Eluciderm’s IND to begin clinical trial of ELU-42

July 9, 2025
No Comments
Eluciderm Inc. has received clearance from the U.S. FDA for its IND to conduct a phase I/IIa open-label study evaluating the safety and efficacy of ELU-42, a topical spray-on solution for open wound healing, in patients with diabetic foot ulcers (DFUs).
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Woman in crowd with anxiety
Neurology/psychiatric

Sensorium Therapeutics to advance lead anxiety program into clinic

July 9, 2025
No Comments
Sensorium Therapeutics Inc. has reported that the U.S. FDA has cleared the IND application for SNTX-2643 (SENS-01), its lead anxiety program. First-in-human dosing begins in Q3 2025.
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Illustration of heart comparing normal heart beat to bradycardia and tachycardia
Cardiovascular

Solid Biosciences cleared to begin phase I studies of SGT-501 in US and Canada

July 9, 2025
No Comments
Solid Biosciences Inc. has announced approvals of its IND application and CTA by the U.S. FDA and Health Canada, respectively, for SGT-501, a novel gene therapy approach for the treatment of catecholaminergic polymorphic ventricular tachycardia (CPVT), a highly malignant, arrhythmogenic channelopathy caused by mutations in the RYR2 and CASQ2 genes.
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Heart and DNA
Cardiovascular

FDA clears Rocket Pharmaceuticals’ IND for gene therapy candidate

June 30, 2025
No Comments
The U.S. FDA has cleared Rocket Pharmaceuticals Inc.’s IND application for RP-A701, an AAVrh.74-based gene therapy candidate for the treatment of BAG3-associated dilated cardiomyopathy (BAG3-DCM), a severe form of heart failure.
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3D illustration showing presence of tumor inside prostate gland
Cancer

Archeus gains IND clearance for ART-101 in prostate cancer

June 23, 2025
No Comments
Archeus Technologies Inc. has obtained IND clearance from the FDA for ART-101, a novel receptor-based targeting small molecule for the imaging and treatment of prostate cancer.
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Tape measure, apple on scale
Endocrine/metabolic

MBX Biosciences files IND application for MBX-4291 for obesity

June 17, 2025
No Comments
MBX Biosciences Inc. has submitted an IND application to the FDA for MBX-4291, a long-acting glucagon-like peptide-1 (GLP-1)/ glucose-dependent insulinotropic polypeptide (GIP) receptor co-agonist prodrug for the treatment of obesity.
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Neurology/psychiatric

Centessa’s OX2R agonist ORX-142 gains IND clearance

June 17, 2025
No Comments
Centessa Pharmaceuticals plc has obtained IND clearance from the FDA to initiate a phase I study of ORX-142 in healthy volunteers. ORX-142 is an investigational, novel, highly potent and selective OX2R agonist being developed for the treatment of select neurological and neurodegenerative disorders.
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CAR T illustration
Immuno-oncology

Myrio’s PHOX2B PC-CAR T for neuroblastoma gains IND clearance

June 16, 2025
No Comments
Myrio Therapeutics Pty Ltd. is set to advance lead product PHOX2B PC-CAR T (PHOX2B peptide-centric chimeric antigen receptor autologous T cells) into clinical trials for relapsed neuroblastoma following IND clearance by the FDA. The first patient will be enrolled around mid-year.
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Steadying hand while reaching for glass
Neurology/psychiatric

Capsida’s CAP-003 receives IND clearance for Parkinson’s disease with GBA mutations

June 12, 2025
No Comments
Capsida Biotherapeutics Inc. has obtained IND clearance from the FDA for CAP-003, an intravenously administered gene therapy, for Parkinson’s disease associated with GBA mutations (PD-GBA). A phase I/II trial will begin dosing in the third quarter of this year.
Read More
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