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Home » Drug & Device Pipeline News

Drug & Device Pipeline News

January 9, 2023
Company Drug/Device Medical Condition Status
Trials Authorized
Arugula Sciences Signature Cord Prime (SIG001) Knee osteoarthritis IND for a phase 1 trial approved by the FDA
ProfoundBio PRO1160 Metastatic renal cell carcinoma, metastatic or relapsed nasopharyngeal carcinoma or advanced non-Hodgkin lymphoma IND for a phase 1 trial approved by the FDA
Tempero Bio TMP-301 Alcohol and substance use disorders IND for a phase 1 trial approved by the FDA
HotSpot Therapeutics HST-1011 Advanced solid tumors in patients who are relapsed or refractory to anti-PD-L1 therapy IND for a phase 1/2 trial approved by the FDA
SURGE Therapeutics STM-416 Non-muscle-invasive bladder cancer IND for a phase 1/2 trial approved by the FDA
Hoth Therapeutics HT-001 Rash and skin disorders associated with epidermal growth factor receptor (EGFR) inhibitor therapy IND for a phase 2a trial approved by the FDA
Azafaros AZ-3102 GM2 gangliosidosis and Niemann-Pick disease type C IND for a phase 2 trial approved by the FDA
Evaxion Biotech EVX-01 plus Keytruda Metastatic melanoma IND for a phase 2b trial approved by the FDA
AB Science Masitinib Progressive forms of multiple sclerosis IND for a phase 3 trial approved by the FDA
Trials Initiated
ArsenalBio AB-1015 Platinum-resistant ovarian cancer Initiation of phase 1 trial
JS InnoPharm JSI-1187 plus dabrafenib Locally advanced or metastatic solid tumors with confirmed BRAF V600E/K mutations Initiation of phase 1 trial
Orano Med 212Pb-GRPR Advanced solid tumors that express gastrin-releasing peptide receptor Initiation of a phase 1 trial
ProfoundBio PRO1184 Ovarian, endometrial, breast, non-small cell lung cancers and mesothelioma Initiation of phase 1 trial
Biomea Fusion BMF-219 Type 2 diabetes Initiation of phase 2 portion of a phase 1/2 trial
Immunitas Therapeutics IMT-009 Solid tumors and hematologic malignancies Initiation of a phase 1/2a trial
Surface Oncology SRF114 Advanced solid tumors Initiation of a phase 1/2 trial
Sensorion SENS-401 (arazasetron) Cisplatin-induced ototoxicity Initiation of a phase 2a trial
Acer Therapeutics ACER-801 (osanetant) To reduce severity of hot flashes in men with adenocarcinoma of the prostate Initiation of a phase 2 trial
Acer Therapeutics ACER-801 (osanetant) To reduce testosterone in men with adenocarcinoma of the prostate Initiation of a phase 2 trial
Horizon Therapeutics Daxdilimab Moderate-to-severe primary discoid lupus erythematosus Initiation of a phase 2 trial
Novavax COVID-19-Influenza combination and stand-alone influenza vaccines COVID-19 and influenza Initiation of a phase 2 trial
OncoC4 ONC-392 plus Keytruda Platinum-resistant ovarian cancer Initiation of a phase 2 trial
Wex Pharmaceuticals Tetrodotoxin Chemotherapy-induced neuropathic pain Initiation of a phase 2b trial
Anthos Therapeutics Abelacimab High-risk patients with atrial fibrillation deemed unsuitable for current anticoagulants Initiation of a phase 3 trial
AriBio USA AR1001 Early Alzheimer’s disease Initiation of a phase 3 trial
Cingulate Therapeutics CTx-1301 Attention deficit/hyperactivity disorder in adults Initiation of a phase 3 trial
NRx Pharmaceuticals NRX-101 Severe bipolar depression with acute suicidal ideation and behavior Initiation of a phase 3 trial
Approvals
Vericel NexoBrid (anacaulase-bcdb) Eschar removal in patients with deep partial- and/or full- thickness thermal burns Approved by the FDA

 

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