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Pipeline
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| COVID-19 Trials and Actions | |||
| RedHill Biopharma | orally administered RHB-107 (upamostat) | patients with symptomatic COVID-19 who do not require hospitalization | IND approved by the FDA for phase 2/3 trial |
| Ampio Pharmaceuticals | inhaled Ampion | COVID-19 | third cohort treated in phase 1 trial |
| Selva Therapeutics | SLV213 | treatment of COVID-19 | first patients dosed in phase 1 trial |
| Revelation Biosciences | REVTx 99 | treatment and prevention of respiratory viral infection, including SARS CoV 2 infection | dosing complete in first cohort of phase 1 trial |
| BioLineRx | Motixafortide | acute respiratory distress syndrome secondary to COVID-19 and other respiratory viral infections | initiation of phase 1b trial |
| Nordic Nanovector | Betalutin (177Lu lilotomab satetraxetan) in combination with rituximab i | second-line follicular lymphoma | final two patients enrolled into second safety cohort of phase 1trial |
| NorthSea Therapeutics | SEFA-1024 | hypertriglyceridemia | first patient dosed in phase 1 trial |
| Biological E. Dynavax Baylor College of Medicine |
COVID-19 subunit vaccine candidate | COVID-19 vaccine | initiation of phase 1/2 trial in India |
| Inovio | INO-4800 | COVID-19 vaccine | initiation of phase 2 portion of phase 2/3 trial |
| RedHill Biopharma | opaganib (Yeliva, ABC294640) | patients hospitalized with severe COVID-19 pneumonia | enrollment complete in phase 2 trial |
| BioNTech Pfizer |
BNT162b2 | mRNA-based COVID-19 vaccine candidate | completion of phase 3 trial |
| Tulip Medical | autologous stem/stromal cells derived from fat | restoration of respiratory function in adults with lung damage from COVID-19 | initiation of clinical trial |
| Lucira Health | Lucira COVID-19 All-In-One Test Kit | COVID-19 rapid diagnostic test for self-testing at home | Emergency Use Authorization granted by the FDA |
| Other Trials and Actions | |||
| ATAI Life Sciences Neuronasal | N-acetylcysteine (NAC) | acute mild traumatic brain injury | IND approved by the FDA |
| Dicerna Pharmaceuticals Eli Lilly |
LY3561774 | cardiometabolic disease | IND approved by the FDA |
| Istari Oncology | PVSRIPO immunotherapy | treatment-refractory melanoma | IND approved by the FDA |
| Jounce Therapeutics | JTX-8064 | solid tumors | IND approved by the FDA |
| Nanobiotix | NBTXR3 activated by radiation therapy | patients with recurrent or metastatic head and neck squamous cell carcinoma with limited PD-L1 expression or refractory to PD-1 blockade | IND approved by the FDA |
| Nanobiotix | NBTXR3 activated by SBRT re-irradiation | patients with inoperable, locoregional recurrent head and neck squamous cell carcinoma (HNSCC) or second primary HNSCC, previously treated with definitive radiation therapy and without radiographic evidence of metastases | IND approved by the FDA |
| NeoImmuneTech | NT-I7 (efineptakin alfa) and atezolizumab (Tecentriq) | patients with previously untreated, PD-L1-expressing, locally advanced or metastatic non-small cell lung cancer | IND approved by the FDA |
| TISSIUM | vascular sealant | achieving hemostasis and preventing postoperative bleeding following peripheral vascular surgeries | IDE approved by the FDA |
| AlzeCure Pharma | ACD856 | Alzheimer's disease | approval from the regulatory authorities in Sweden to initiate a phase 1 study |
| EicOsis Human Health | EC5026 | moderate to severe pain | phase 1a trial complete |
| BridgeBio Navire Pharma |
BBP-398 | solid tumors driven by mutations in the MAPK signaling pathway | first patient dosed in phase 1 trial |
| Nkarta | NKX101 immunotherapy | relapsed/refractory acute myeloid leukemia or higher-risk myelodysplastic syndromes | first patient dosed in phase 1 trial |
| PTC Therapeutics | PTC518 | Huntington's disease | initiation of phase 1 trial |
| Pionyr Immunotherapeutics | PY314 | solid tumors | initiation of phase 1 trial |
| Precigen | PRGN-3005 UltraCAR-T cells | advanced ovarian cancer | first patients dosed in the intraperitoneal arm of ongoing phase 1 trial |
| Precigen | PRGN-3006 UltraCAR-T cells | relapsed or refractory acute myeloid leukemia and higher risk myelodysplastic syndrome | first patients dosed in phase 1/1b trial |
| CG Oncology | CG0070 in combination with Opdivo (nivolumab) | muscle-invasive bladder cancer in cisplatin-ineligible patients | first patient treated in phase 1b trial |
| Kangpu Biopharmaceuticals | KPG-818 | systemic lupus erythematosus | initiation of phase 1b/2a trial |
| KAHR Roche |
DSP107 | solid tumors | first patient dosed in phase 1/2 trial |
| Takeda Pharmaceuticals | mezagitamab (TAK-079) | generalized myasthenia gravis | first patient dosed in phase 2 trial |
| Cerebral Therapeutics | intracerebroventricular drug delivery of CT-010 | medically refractory epilepsy | first patient enrolled in phase 2b trial |
| Kodiak Sciences | KSI-301 | neovascular (wet) age-related macular degeneration | enrollment complete in phase 2b/3 trial |
| AZTherapies | ALZT-OP1 | early stage Alzheimer’s disease | completion of last patient/last visit in phase 3 trial |
| Corvia Medical | Corvia Atrial Shunt (IASD) | to reduce elevated left atrial pressures | randomization complete in phase 3 trial |
| DeNovo Biopharma | DB102 | newly diagnosed high-risk diffuse large B-cell lymphoma patients with the biomarker DGM1 | enrollment complete in phase 3 trial |
| Milestone Pharmaceuticals | etripamil nasal spray | paroxysmal supraventricular tachycardia | first patient enrolled in phase 3 trial |
| Palladio Biosciences | lixivaptan | patients with autosomal dominant polycystic kidney disease who previously discontinued therapy with tolvaptan due to liver toxicity | first patient dosed in phase 3 trial |
| SIFI | polihexanide 0.08% | acanthamoeba keratitis | enrollment complete in phase 3 trial |
| TissueTech | TTAX01 | advanced nonhealing diabetic foot ulcers | initiation of phase 3 trial |
| Sommetrics | aerSleep II | sleep apnea | Breakthrough Device designation granted by the FDA |
| Kiniksa Pharmaceuticals | vixarelimab | pruritus associated with prurigo nodularis | Breakthrough Therapy designation granted by the FDA |
| ViiV Healthcare | cabotegravir | HIV pre-exposure prophylaxis | Breakthrough Therapy designation granted by the FDA |
| Agios Pharmaceuticals | mitapivat | sickle cell disease | Orphan Drug designation granted by the FDA |
| Amylyx Pharmaceuticals | AMX0035 | Wolfram syndrome | Orphan Drug designation granted by the FDA |
| Sanofi | rilzabrutinib | immune thrombocytopenia | Fast Track designation granted by the FDA |
| Agilent Technologies | PD-L1 IHC 22C3 pharmDx | companion diagnostic to aid in identification of TNBC patients eligible for treatment with Keytruda | approved by the FDA |
| Merck | Keytruda (pembrolizumab) | patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors express PD-L1 | approved by the FDA |
| SafKan Health | OtoSet Ear Cleaning System | removal of impacted earwax | approved by the FDA |
| UCB Pharma | Vimpat (lacosamide) CV | adjunctive therapy for primary generalized tonic-clonic seizures (PGTCS) in patients four years of age and older | approved by the FDA for expanded indication |
| UCB Pharma | Vimpat injection | intravenous use in children four years of age and older with PGTCS | approved by the FDA for expanded indication |
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