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Pipeline
January 25, 2021
Company | Drug/Device | Medical Condition | Status |
---|---|---|---|
COVID-19 Trials and Actions | |||
EuBiologics | EuCorVac-19 | COVID-19 vaccine | IND approved by the Ministry of Food and Drug Safety in Japan for a phase 1/2 trial |
ImmunityBio | hAd5 T-cell COVID-19 vaccine | COVID-19 vaccine | authorization from the South Africa Health Products Regulatory Authority to begin a phase I trial |
Moderna Takeda |
COVID-19 vaccine (mRNA-1273 or TAK-919) | COVID-19 vaccine | first patient dosed in phase 1/2 trial |
Cyxone | rabeximod | hospitalized COVID-19 patients | first patient screened in phase 2 trial |
Debiopharm | alisporivir (Debio 025) | early-stage hospitalized COVID-19 patients not requiring medical ventilation nor exhibiting signs of acute respiratory distress syndrome | first patient dosed in phase 2 trial |
Algernon Pharmaceuticals | NP-120 (Ifenprodil) | COVID-19 cytokine storm | approval to begin phase 3 portion of phase 2b/3 trial |
Dr. Reddy’s Labs | Sputnik V vaccine | COVID-19 vaccine | approval from the Drugs Controller General of India to conduct phase 3 trial |
SML Genetree | Ezplex SARS-CoV-2 G Kit | molecular diagnostic test for the qualitative detection of RNA from SARS-CoV-2 | Emergency Use Authorization (EUA) granted by the FDA |
Other Trials and Actions | |||
EdiGene | ET-01, CRISPR/Cas 9 gene-editing therapy | patients with transfusion dependent ?-thalassemia | IND approved by the FDA |
Molecular Templates | MT-6402 | relapsed/refractory patients with PD-L1-positive solid tumors | IND approved by the FDA |
Precision Biosciences | PBCAR19B | relapsed/refractory nonHodgkin lymphoma | IND approved by the FDA |
Terns Pharmaceuticals | TERN-501 | nonalcoholic steatohepatitis | IND approved by the FDA |
Aptorum Group | ALS-4 | staphylococcus aureus infections, including MRSA | phase 1 trial approved by the Public Health Agency of Canada |
BioEclipse Therapeutics | CRX100 | refractory solid tumors | initiation of patient enrollment in phase 1 trial |
Bio-Thera Solutions | BAT1308 | advanced solid tumors | first patients dosed in phase 1 trial |
Forma Therapeutics | FT-7051 | metastatic castration-resistant prostate cancer | first patient dosed in phase 1 trial |
Lyndra Therapeutics | LYN-047 (rosuvastatin extended-release capsule) | dyslipidemia | first patient dosed in phase 1 trial |
Sutro Biopharma | STRO-002 | ovarian cancer | first patient dosed in dose-expansion cohort of phase 1 trial |
Sumitomo Dainippon Pharma Oncology | TP-0184 | anemia in adult patients with low- or intermediate-risk myelodysplastic syndromes | first patient dosed in phase 1/2 trial |
Sirnaomics | STP705 | cutaneous basal cell carcinoma | first patient dosed in phase 2a trial |
Apnimed | AD109 | mild-to-moderate obstructive sleep apnea | first patient dosed in phase 2 trial |
AriBio | AR1001 | mild-to-moderate Alzheimer’s disease | completion of last patient, last visit in phase 2 trial |
InCarda Therapeutics | InRhythm (flecainide for inhalation) | recent-onset paroxysmal atrial fibrillation | first patient dosed in the U.S. in phase 2 trial |
AzurRx BioPharma | MS1819 immediate release capsules | exocrine pancreatic insufficiency in patients with cystic fibrosis | first two patients dosed in phase 2b extension study |
Caladrius Biosciences | CLBS16 | coronary microvascular dysfunction | first patient dosed in phase 2b trial |
Cellectar Biosciences | CLR 131 | Waldenstrom’s macroglobulinemia | initiation of phase 3 trial |
Bausch + Lomb | NOV03 | dry-eye disease associated with meibomian gland dysfunction | patient enrollment complete in phase 3 trial |
Calliditas | NefIgArd | primary IgA nephropathy | patient enrollment complete in phase 3 trial |
Oramed | ORMD-0801, oral insulin capsule | type 2 diabetes | first patients enrolled in phase 3 trial |
Phathom Pharmaceuticals | vonoprazan in combination with amoxicillin (dual therapy) or with amoxicillin and clarithromycin (triple therapy) | h. pylori infection | patient enrollment complete in phase 3 trial |
Tessa Therapeutics | autologous CD30 CAR-T therapy | relapsed or refractory classical Hodgkin lymphoma | PRiority MEdicines (PRIME) designation granted by the European Medicines Agency |
Taysha Gene Therapies | TSHA-105, AAV9-based gene therapy | SLC13A5-related epilepsy | Rare Pediatric Disease and Orphan Drug designations granted by the FDA |
Occlutech | implantable Atrial Flow Regulator | heart failure patients with preserved or reduced ejection fraction | Breakthrough Device designation granted by the FDA |
Swedish Orphan Biovitrum | Doptelet (avatrombopag) | primary chronic immune thrombocytopenia refractory to other treatments | approved by the European Commission |
AstraZeneca Daiichi Sankyo |
Enhertu (fam-trastuzumab deruxtecan-nxki) | patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen | approved by the FDA for expanded indication |
Janssen | Darzalex Faspro in combination with bortezomib, cyclophosphamide and dexamethasone | adults with newly diagnosed light chain amyloidosis | approved by the FDA for expanded indication |
Merck | Verquvo (vericiguat) | to reduce the risk of cardiovascular death and heart failure hospitalization or need for outpatient intravenous diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45 percent | approved by the FDA |
Orthocell | Striate+ | collagen medical device for dental bone and tissue regeneration procedures | approved by the FDA |
Pfizer | Xalkori (crizotinib) | pediatric patients one year of age and older and young adults with relapsed or refractory systemic anaplastic large-cell lymphoma that is anaplastic lymphoma kinase-positive | approved by the FDA for expanded indication |
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