
Home » Pipeline
Pipeline
Company |
Drug/Device |
Medical Condition |
Status |
COVID-19 Trials and Actions | |||
AB201 (rNAPc2) |
patients hospitalized with COVID-19 |
IND approved by the FDA |
|
hAd5-COVID-19 |
COVID-19 vaccine |
IND approved by the FDA |
|
GP1681 |
COVID-19 cytokine storm (hypercytokinemia) |
initiation of phase 1 trial |
|
TLC19 (liposomal suspension of hydroxychloroquine for inhalation) |
prophylaxis of COVID-19 |
first patient enrolled in phase 1 trial |
|
VXA-CoV2-1 |
oral tablet COVID-19 vaccine |
first patient dosed in phase 1 trial |
|
Allocetra |
severe and critical COVID-19 patients |
initiation of phase 2 trial |
|
fostamatinib |
hospitalized COVID-19 patients |
first patients enrolled in phase 2 trial |
|
remdesivir (Vitrakvy) and hyperimmune intravenous immunoglobulin (hIVIG) |
adults hospitalized for COVID-19 with symptoms for 12 days or fewer without life-threatening organ dysfunction or organ failure |
initiation of phase 3 trial |
|
The CoVIg-19 Plasma Alliance/National Institute of Allergy and Infectious Diseases |
anticoronavirus hyperimmune intravenous immunoglobulin (H-Ig) medicine |
hospitalized adults at risk for serious complications of COVID-19 disease |
first patients enrolled in phase 3 trial |
AdviseDx SARS-CoV-2 IgM (Immunoglobulin M) lab-based serology test |
diagnosis of COVID-19 |
Emergency Use Authorization granted by the FDA |
|
Other Trials and Actions |
|
|
|
AP-PA02 |
pseudomonas aeruginosa infections |
IND approved by the FDA |
|
ASC42 |
nonalcoholic steatohepatitis |
IND approved by the FDA |
|
NBTXR3 activated by radiation therapy |
lung cancer and esophageal cancer |
IND approved by the FDA |
|
NUV-422 |
patients with high-grade gliomas |
IND approved by the FDA |
|
allergy gummy medication |
allergies |
IND approved by the FDA |
|
Therapeutic Intra-Vascular Ultrasound (TIVUS) System |
pulmonary arterial hypertension |
IDE approved by the FDA |
|
AZP-3601 |
hypoparathyroidism |
first patient dosed in phase 1 trial |
|
NBTXR3 activated by radiation therapy |
pancreatic cancer |
first patient dosed in phase 1 trial |
|
TP-1454 administered alone and in combination with ipilimumab and nivolumab |
advanced metastatic or progressive solid tumors |
first patient dosed in phase 1 trial |
|
BOLD-100 in combination with FOLFOX |
advanced gastric, pancreatic, colorectal and bile duct cancers |
phase 1b trial initiated |
|
CDX-0159 |
chronic spontaneous urticaria |
first patient dosed in phase 1b trial |
|
EDP1815 |
mild to moderate atopic dermatitis |
patient enrollment complete in phase 1b trial |
|
RGLS4326 |
autosomal dominant polycystic kidney disease |
first patients dosed in phase 1b trial |
|
FCX-013 |
moderate to severe localized scleroderma |
first patient dosed in phase 1/2 trial |
|
LNS8801 in combination with Keytruda (pembrolizumab) |
advanced cancer |
first patient dosed in phase 1/2 trial |
|
Biolen device |
localized sustained delivery of bicalutamide into the prostate of men scheduled for prostate surgery for treatment of nonmetastatic prostate cancer |
first patient enrolled in phase 2 trial |
|
EDP1815 |
mild to moderate psoriasis |
first patient dosed in phase 2 trial |
|
Agili-C implant |
cartilage lesions in arthritic and nonarthritic joints |
Breakthrough Device designation granted by the FDA |
|
lanifibranor |
nonalcoholic steatohepatitis |
Breakthrough Therapy designation granted by the FDA |
|
miR Sentinel PCC4 Assay (miR Sentinelä Prostate Test) |
prostate cancer liquid biopsy test |
Breakthrough Device designation granted by the FDA |
|
AXO-AAV-GM2 |
GM2 gangliosidosis |
Rare Pediatric Disease designation granted by the FDA |
|
CT-179 |
medulloblastoma |
Rare Pediatric Disease designation granted by the FDA |
|
givinostat |
Duchenne Muscular Dystrophy |
Rare Pediatric Disease designation granted by the FDA |
|
OXU-003 |
retinoblastoma |
Rare Pediatric Disease and Orphan Drug designation granted by the FDA |
|
nivatrotamab |
neuroblastoma |
Rare Pediatric Disease and Orphan Drug designation granted by the FDA |
|
Orca-T |
patients with blood cancers who are eligible for a hematopoietic stem-cell transplant |
Regenerative Medicine Advanced Therapy designation granted by the FDA |
|
APX005M |
esophageal- and gastroesophageal-junction cancer and pancreatic cancer |
Orphan Drug designation granted by the FDA |
|
APG-115 |
acute myeloid leukemia |
Orphan Drug designation granted by the FDA |
|
APG-1252 |
small-cell lung cancer |
Orphan Drug designation granted by the FDA |
|
Trodelvy (sacituzumab govitecan-hziy) |
adult and pediatric patients with glioblastoma |
Orphan Drug designation granted by the FDA |
|
Orca-T |
enhancing cell engraftment in patients who qualify for a hematopoietic stem-cell transplant |
Orphan Drug designation granted by the FDA |
|
RHB-204 |
nontuberculous mycobacteria disease |
Orphan Drug designation granted by the FDA |
|
Ultomiris (ravulizumab-cwvz) |
adults with paroxysmal nocturnal hemoglobinuria and for atypical hemolytic uremic syndrome |
approved by the FDA for new formulation |
|
Palynziq (pegvaliase-pqpz) Injection |
adults with phenylketonuria |
approved by the FDA for expanded dosing |
|
CrossGlide ETS Plus, Endometrial Tissue Sampler |
endometrial biopsy procedure |
approved by the FDA |
|
Telegraph Evolution, humeral nailing system |
proximal and/or mid-shaft humeral fractures |
approved by the FDA |
|
Wakix (pitolisant) |
cataplexy in adult patients with narcolepsy |
approved by the FDA for expanded indication |
|
Keytruda (pembrolizumab) |
monotherapy for adults with relapsed or refractory classical Hodgkin lymphoma |
approved by the FDA for expanded indication |
|
Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn) |
Zaire ebolavirus |
approved by the FDA |
Upcoming Events
-
05Dec
-
14Apr