Drug & Device Pipeline News
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Trials Authorized | |||
| Ilya Pharma | ILP100-Topical | Surgical wounds in patients with prediabetes, diabetes and obesity | IND approved by the FDA |
| Inmagene Biopharmaceuticals | IMG-007 | Atopic dermatitis | IND approved by the FDA |
| Vitti Labs | Mesenchymal stem cells and exosomes | Pulmonary fibrosis secondary to COVID-19 infection | IND approved by the FDA for phase 2 trial |
| Moleculin Biotech | Annamycin (L-ANN) in combination with Cytarabine (Ara-C) | Acute myeloid leukemia | Approval for a phase 1/2 trial granted by Poland’s regulatory authority |
| Palisade Bio | LB1148 | Accelerated return of bowel function following abdominal surgery | Approval for a phase 3 trial granted by China’s regulatory authority |
| Trials Initiated | |||
| Delpor | DLP-160 (six- to 12-month naltrexone implant) | Opioid use disorder | Initiation of phase 1 trial |
| Alaunos Therapeutics | TCR-T-cell therapy | Solid tumors | Initiation of phase 1/2 trial |
| Aulos Bioscience | AU-007 | Solid tumors | Initiation of phase 1/2 trial |
| Alzamend Neuro | AL001 | Dementia related to Alzheimer’s | Initiation of phase 2a trial |
| Denali Therapeutics Sanofi |
SAR443820 (DNL788) | Amyotrophic lateral sclerosis | Initiation of phase 2 trial |
| Kintor Pharmaceutical | GT90001 plus Opdivo (nivolumab) | Advanced hepatocellular carcinoma | Initiation of phase 2 trial |
| Saol Therapeutics | SL-1002 | Limb spasticity | Initiation of phase 2 trial |
| Xenon Pharmaceuticals | XEN1101 | Major depressive disorder | Initiation of phase 2 trial |
| HilleVax | HIL-214 | Prevention of norovirus-related acute gastroenteritis in infants | Initiation of phase 2b trial |
| AstraZeneca | Durvalumab in combination with monalizumab or oleclumab | Unresectable stage 3 nonsmall-cell lung cancer | Initiation of phase 3 trial |
| BioXcel Therapeutics | BXCL501 | Acute agitation in patients with Alzheimer’s disease | Initiation of phase 3 trial |
| Paradigm Biopharmaceuticals | Zilosul (injectable pentosan polysulfate sodium) | Pain associated with knee osteoarthritis | Initiation of phase 3 trial |
| PolarityTE | SkinTE | Diabetic foot ulcers | Initiation of phase 3 trial |
| Therapeutic Solutions | JadiCell | COVID-19-associated lung failure | Initiation of phase 3 trial |
| Approvals | |||
| Bristol Myers Squibb | Camzyos (mavacamten) | Obstructive hypertrophic cardiomyopathy | Approved by the FDA |
| Mycovia Pharmaceuticals | Vivjoa (oteseconazole capsules) | Recurrent vulvovaginal candidiasis | Approved by the FDA |
| Orphalan | Cuvrior (trientine tetrahydrochloride) | Wilson’s disease | Approved by the FDA |
| Phathom Pharmaceuticals | Voquezna Triple Pak (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and Voquezna Dual Pak (vonoprazan tablets, amoxicillin capsules) | Helicobacter pylori infection in adults | Approved by the FDA |
| AbbVie | Rinvoq (upadacitinib) | Active ankylosing spondylitis | Approved by the FDA for new indication |
| Alexion | Ultomiris (ravulizumab-cwvz) | Generalized myasthenia gravis in adults | Approved by the FDA for new indication |
| AstraZeneca Daiichi Sankyo |
Enhertu (trastuzumab deruxtecan) | HER2-positive metastatic breast cancer patients previously treated with an anti-HER2-based regimen | Approved by the FDA for expanded indication |
| Supernus Pharmaceuticals | Qelbree (viloxazine extended-release capsules) | Attention deficit hyperactivity disorder in adults | Approved by the FDA for expanded indication |
| iSono Health | Atusa system | Breast imaging | Approved by the FDA |
| Silk Road Medical | Enroute stent | Carotid endarterectomy | Approved by the FDA for expanded indication |
| Horizon Therapeutics | Uplizna (inebilizumab) | Neuromyelitis optica spectrum disorder in adults | Approved by the European Commission |
| Incyte | Jakavi (ruxolitinib) | Acute or chronic graft-vs.-host disease | Approved by the European Commission |
| Ipsen | Cabometyx (cabozantinib) | Radioactive iodine-refractory differentiated thyroid cancer | Approved by the European Commission |
| Merck | Keytruda (pembrolizumab) | MSI-H or dMMR colorectal cancer, endometrial carcinoma, gastric or biliary cancer | Approved by the European Commission |
| Merck | Keytruda in combination with chemotherapy, with or without bevacizumab | Persistent, recurrent or metastatic cervical cancer in adults whose tumors express PD-L1 | Approved by the European Commission |
| BeiGene | Blincyto (blinatumomab) | Relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia in children | Approved in China |
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