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Drug & Device Pipeline News
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Trials Authorized | |||
| Bexion Pharmaceuticals | BXQ-350 | Newly diagnosed stage 4 metastatic colorectal cancer | IND approved by the FDA |
| Pharmazz | centhaquine | Hypovolemic shock | IND approved by the FDA |
| Everest Medicines | SPR206 (EVER206) | Multi-drug resistant gram-negative bacterial infections | IND approved by China’s regulatory authority |
| I-Mab | enoblituzumab in combination with pembrolizumab (Keytruda) | Selected solid tumors | IND approved by China’s regulatory authority for a phase 2 trial |
| Transcenta Holding | TST002 | Postmenopausal osteoporosis | IND approved by China’s regulatory authority |
| AB Science | masitinib | Treatment of patients with symptomatic mild-to-moderate COVID-19 | Approval for a phase 2 trial granted by Russia and South Africa’s regulatory authorities |
| Krystal Biotech | KB407 | Cystic fibrosis | Approval for a phase 1 trial granted by Australia’s regulatory authority |
| MRM Health | MH002 | Ulcerative colitis | Approval for a Phase 1b/2a trial granted by Belgium’s regulatory authority |
| Revelation Biosciences | REVTx-99 | Prevention of influenza | Approval for a Phase 2b trial granted by Belgium’s regulatory authority |
| Kintor Pharma | Proxalutamide | Hospitalized COVID-19 patients | Approval for a phase 3 trial granted by Brazil’s regulatory authority |
| Lipidor | AKP02 | Psoriasis | Approval for a phase 3 trial granted by India’s regulatory authority |
| Trials Initiated | |||
| ADC Therapeutics | ADCT-901 | Selected advanced solid tumors | Initiation of phase 1 trial |
| CyanVac Blue Lake Biotechnology |
CVXGA1 intranasal COVID-19 vaccine | COVID-19 vaccine | Initiation of phase 1 trial |
| Dicerna | DCR-AUD | Alcohol use disorder | Initiation of phase 1 trial |
| Glyscend | Polymer duodenal exclusion therapy | Obesity | Initiation of phase 1 trial |
| VBI Vaccines | VBI-2905 | SARS-CoV-2 vaccine | Initiation of phase 1b trial |
| Artios Pharma | ART4215 | Advanced or metastatic solid tumors | Initiation of phase 1/2 trial |
| GenFleet Therapeutics Innovent |
GFH925 | KRAS G12C mutated late-stage nonsmall-cell lung cancer and gastrointestinal cancer | Initiation of phase 1/2 trial |
| Addex Therapeutics | dipraglurant | Blepharospasm | Initiation of phase 2a trial |
| Allena Pharmaceuticals | ALLN-346 | Gout in patients with chronic kidney disease | Initiation of phase 2a trial |
| Immunic | IMU-838 | Progressive multiple sclerosis | Initiation of phase 2 trial |
| InMed Pharmaceuticals | INM-755 (cannabinol) cream | Epidermolysis Bullosa | Initiation of phase 2 trial |
| Arrowhead Pharmaceuticals | ARO-APOC3 | Mixed dyslipidemia. | Initiation of phase 2b trial |
| Pfizer | PF-07321332, co-administered low dose ritonavir | Prevention of COVID-19 infection | Initiation of phase 2/3 trial |
| SAB Biotherapeutics | SAB-185 | Nonhospitalized patients with mild-to-moderate COVID-19 | Initiation of phase 3 portion of phase 2/3 trial |
| Janssen | Respiratory syncytial virus (RSV) vaccine | Lower respiratory tract disease caused by RSV | Initiation of phase 3 trial |
| Syros Pharmaceuticals | SY-2101 | Newly diagnosed acute promyelocytic leukemia patients | Initiation of phase 3 trial |
| Approvals | |||
| AbbVie | Qulipta (atogepant) | Preventive treatment of episodic migraine in adults | Approved by the FDA |
| Amgen | Repatha (evolocumab) | Adjunct for the treatment of patients older than 10 years old with heterozygous familial hypercholesterolemia (HeFH) to reduce LDL-C | Approved by the FDA for expanded indication |
| Eli Lilly | Erbitux (cetuximab injection) in combination with Braftovi (encorafenib) | Adults with previously treated metastatic colorectal cancer with a BRAF V600E mutation | Approved by the FDA for new indication |
| Mirum Pharmaceuticals | Livmarli (maralixibat) oral solution | Cholestatic pruritus in patients with Alagille syndrome older than one year of age | Approved by the FDA |
| Biotronik | Orsiro Mission bioabsorbable polymer drug-eluting stent system | Percutaneous coronary intervention device | Approved by the FDA |
| ANP Technologies | NIDS COVID-19 Antigen Rapid Test Kit | Detection of SARS-CoV-2 | Emergency Use Authorization granted by the FDA |
| Astellas SeaGen |
Padcev (enfortumab vedotin) | Radically unresectable urothelial carcinoma that has progressed after anti-cancer chemotherapy | Approved in Japan |
| ChemoCentryx Kissei Pharmaceuticals |
Tavneos (avacopan) | Microscopic polyangiitis and granulomatosis with polyangiitis | Approved in Japan |
| Pfizer | Cibnqo (abrocitinib) | moderate-to-severe atopic dermatitis in patients older than 12 years of age | Approved in Japan |
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