Home » Pipeline
Pipeline
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Company |
Drug/Device |
Medical Condition |
Status |
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COVID-19 Trials and Actions |
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Senhwa Biosciences and Center for Advanced Research and Education |
silmitasertib |
patients with moderate COVID-19 |
IND approved by the FDA |
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CPI-006 |
hospitalized patients with COVID-19 |
patient enrollment complete in phase 1 trial |
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Quellor |
pulmonary complications from COVID-19 |
first patient dosed in phase 2 trial |
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Camostat Mesilate |
COVID-19 in high-risk outpatients |
initiation of phase 2 trial |
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Coronavirus-Like Particle COVID-19 vaccine candidate (CoVLP) |
COVID-19 |
initiation of phase 2/3 trial |
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bamlanivimab (LY-CoV555) |
mild-to-moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization |
Emergency Use Authorization (EUA) granted by the FDA |
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cPass SARS-CoV-2 Neutralization Antibody Detection Kit |
detection of SARS-CoV-2 neutralizing antibodies |
EUA granted by the FDA |
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Other Trials and Actions |
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AXO-AAV-GM2 gene therapy |
Tay-Sachs disease and Sandhoff disease |
IND approved by the FDA |
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vafidemstat |
borderline personality disorder |
clinical trial approval granted by Spanish Drug Agency for phase 2b trial |
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7HP349 |
immunostimulant to improve the effectiveness of immunotherapies |
first patients dosed in phase 1 trial |
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AGT103-T |
HIV |
first patient enrolled in phase 1 trial |
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EDG-5506 |
Becker muscular dystrophy |
initiation of phase 1 trial |
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MaaT033 |
patients with acute myeloid leukemia or high-risk myelodysplastic syndrome following intensive chemotherapy |
first patient dosed in phase 1 trial |
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W0180 |
relapsed or refractory solid tumors |
initiation of phase 1 trial |
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SER-301 |
active mild-to-moderate ulcerative colitis |
first patient dosed in phase 1b trial |
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OpRegen |
dry age-related macular degeneration with geographic atrophy |
patient enrollment complete in phase 1/2 trial |
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RLYB211 |
prevention of fetal and neonatal alloimmune thrombocytopenia |
first patients dosed in phase 1/2 trial |
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GT005 |
geographic atrophy secondary to dry age-related macular degeneration |
first patient dosed in phase 2 trial |
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CRV431 |
nonalcoholic steatohepatitis (NASH) |
enrollment in first dose cohort of phase 2 trial complete |
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AMX0035 |
Alzheimer's disease |
last patient visit complete in phase 2 trial |
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vosoritide |
infants with achondroplasia at risk of requiring cervicomedullary decompression surgery to alleviate compression at the foramen magnum |
first patient enrolled in phase 2 trial |
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vosoritide |
children with certain genetic forms of short stature |
first patients enrolled in phase 2 trial |
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EB613 |
postmenopausal females with osteoporosis |
patient enrollment complete in phase 2 trial |
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PDS0101 and Keytruda (pembrolizumab) |
HPV16-positive head and neck cancer that has returned or spread |
initiation of phase 2 trial |
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MK-4830 and Keytruda |
PD-L1-positive advanced nonsmall-cell lung cancer |
initiation of phase 2 trial |
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LUM-201 |
pediatric growth hormone deficiency |
initiation of phase 2b trial |
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recombinant human Alkaline Phosphatase |
sepsis-associated acute kidney injury, patients with moderate chronic kidney disease and patients with COVID-19 |
first patient enrolled in phase 3 trial |
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APL-1702 (Cevira) |
high-grade squamous intraepithelial lesions |
first patient enrolled in phase 3 trial |
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CYP-004 |
osteoarthritis |
initiation of phase 3 trial |
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resmetirom |
patients with presumed NASH who are diagnosed using noninvasive assessments |
patient enrollment complete in phase 3 trial |
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edaravone (MT-1186) oral suspension |
amyotrophic lateral sclerosis |
patient enrollment complete in phase 3 trial |
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NVK-002 |
to slow the progression of myopia in children |
first patient completed three-year enrollment in phase 3 trial |
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oregovomab |
newly diagnosed patients with advanced epithelial ovarian, fallopian tube or peritoneal carcinoma |
first patients dosed in the U.S. in phase 3 trial |
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0.1% RGN-259 eye drops |
dry eye syndrome |
last patient, last visit complete in phase 3 trial |
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IO-202 |
acute myeloid leukemia |
Orphan Drug designation granted by the FDA |
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AMO-02 |
congenital myotonic dystrophy |
Rare Pediatric Disease designation granted by the FDA |
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SRF388 |
patients with previously treated hepatocellular carcinoma |
Fast-Track designation granted by the FDA |
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AB-205 |
the treatment of organ vascular niche injuries to prevent or reduce severe regimen-related toxicities in patients with Hodgkin lymphoma and nonHodgkin lymphoma undergoing high-dose therapy and autologous hematopoietic stem cell transplantation |
Regenerative Medicine Advanced Therapy designation granted by the FDA |
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NightWare therapeutic platform |
temporary reduction of sleep disturbance related to nightmares in adults 22 years or older who suffer from nightmare disorder or have nightmares from PTSD |
approved by the FDA |
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Sesquient (fosphenytoin sodium for injection) |
status epilepticus in adult and pediatric patients |
approved by the FDA |
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SUTAB (sodium sulfate, magnesium sulfate, and potassium chloride) tablets |
colonoscopy preparation |
approved by the FDA |
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