Home » Drug & Device Pipeline News - May 6, 2024
Drug & Device Pipeline News - May 6, 2024
This week’s Pipeline features a phase 3 trial approval for Alzheimer’s disease, a phase 2 trial start for newly diagnosed glioblastoma multiforme and an FDA approval for a spinal cord stimulator that treats chronic pain.
Company | Drug/Device | Medical Condition | Status |
---|---|---|---|
Trials Authorized | |||
Context Therapeutics | CTIM-76 | CLDN6-positive gynecologic and testicular cancers | IND for a phase 1 trial approved by the FDA |
ENA Respiratory | INNA-051 dry powder formulation | Prevention of complications associated with respiratory viral infections in at-risk populations | IND for a phase 1b trial approved by the FDA |
Prime Medicine | PM359 | Chronic granulomatous disease | IND for a phase 1/2 trial approved by the FDA |
Replay University of Texas MD Anderson Cancer Center |
PRAME TCR/IL-15 NK (SY-307) cell therapy | Relapsed/refractory myeloid malignancies | IND for a phase 1/2 trial approved by the FDA |
Ellipses Pharma | EP0031/A400 | RET-altered tumors | IND for a phase 2 trial approved by the FDA |
Palatin Technologies | Bremelanotide plus Mounjaro (tirzepatide) | Obesity | IND for a phase 2 trial approved by the FDA |
Freedom Biosciences | FREE001 | Treatment-resistant depression | IND for a phase 2a trial approved by the FDA |
Discovery Therapeutics Caribe | Intralesional recombinant human epidermal growth factor | Complex and complicated refractory neuropathic, ischemic and neuroischemic diabetic foot ulcers | IND for a phase 3 trial approved by the FDA |
MannKind | MNKD-101 (clofazimine inhalation suspension) | Nontuberculous mycobacterial lung disease | IND for a phase 3 trial approved by the FDA |
AriBio | AR1001 | Alzheimer’s disease | Approval for a phase 3 trial granted by the European Medicines Agency |
Trials Initiated | |||
Alumis | A-005 | Neuroinflammatory and neurodegenerative diseases | Initiation of a phase 1 trial |
Bitterroot Bio | BRB-002 | Atherosclerotic cardiovascular disease | Initiation of a phase 1 trial in Australia |
Guangzhou Bio-gene Technologies | BG1805 | Relapsed/refractory acute myeloid leukemia | Initiation of a phase 1 trial in China |
PEP Therapy Institut Curie |
PEP-010 | Ovarian and pancreatic cancers | Initiation of a phase 1b trial in France |
HiberCell Merck |
HC-7366 plus Welireg (belzutifan) | Advanced clear cell renal cell carcinoma | Initiation of a phase 1b trial |
ArsenalBio | AB-2100 | Clear cell renal cell carcinoma | Initiation of a phase 1/2 trial |
Ellipses Pharma | EP0031/A400 | RET-altered tumors | Initiation of a phase 2 trial |
In8bio | INB-400 | Newly diagnosed glioblastoma multiforme | Initiation of a phase 2 trial |
Gilgamesh Pharmaceuticals | GM-1020 | Major depressive disorder | Initiation of a phase 2a trial |
Technoderma Medicines | TDM-180935 | Atopic dermatitis | Initiation of a phase 2a trial |
Veru | Enobosarm plus Wegovy (semaglutide) | Muscle loss associated with weight loss | Initiation of a phase 2b trial |
Approvals | |||
Genmab Pfizer |
Tivdak (tisotumab vedotin-tftv) | Recurrent or metastatic cervical cancer | Approved by the FDA |
Pfizer | Beqvez (fidanacogene elaparvovec-dzkt) | Hemophilia B in adults | Approved by the FDA |
Utility Therapeutics | Pivya (pivmecillinam) | Uncomplicated urinary tract infections in adult women | Approved by the FDA |
X4 Pharmaceuticals | Xolremdi (mavorixafor) | WHIM syndrome in patients age 12 years and older | Approved by the FDA |
Neurocrine Biosciences | Ingrezza (valbenazine) sprinkle formulation | Huntington’s disease | Approved by the FDA in a new formulation |
Aquestive Therapeutics | Libervant (diazepam) buccal film | Acute treatment of intermittent seizure clusters that are distinct from a patient’s usual pattern in patients with epilepsy between age 2 to 5 years | Approved by the FDA for expanded patient population |
Abbott Laboratories | Esprit BTK Everolimus-eluting resorbable scaffold system | Chronic limb-threatening ischemia below the knee | Approved by the FDA |
Medtronic | Inceptiv closed-loop rechargeable spinal cord stimulator | Chronic pain | Approved by the FDA |
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