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Pipeline
Company | Drug/Device | Medical Condition | Status |
---|---|---|---|
COVID-19 Trials and Actions | |||
Denali Therapeutics Sanofi |
DNL758 (SAR443122) | hospitalized adult patients with severe COVID-19 lung disease | first patients dosed in phase 1b trial |
AI Therapeutics | LAM-002A | patients with confirmed COVID-19 | initiation of phase 2 trial |
Apogenix | asunercept | patients with severe COVID-19 | clearance to initiate a phase 2 trial in Russia |
Constant Therapeutics | TXA127 | patients with COVID-19 who require oxygen but are not in the ICU | initiation of phase 2 trial |
Pfizer BioNTech |
BNT162b2 vaccine candidate | COVID-19 | initiation of phase 2/3 trial |
RedHill Biopharma | opaganib (Yeliva) | patients hospitalized with severe COVID-19 and pneumonia requiring treatment with supplemental oxygen | initiation of phase 2/3 trial |
Moderna | mRNA-1273 vaccine candidate | COVID-19 | dosing of first patients in phase 3 trial |
ReAlta Life Sciences | RLS-0071 | acute lung injury secondary to COVID-19 | IND approved by the FDA |
Color | COVID-19 testing without clinical monitoring | COVID-19 | Emergency Use Authorization (EUA) granted by the FDA |
Truvian Sciences | Easy Check COVID-19 IgM/IgG antibody test | COVID-19 | EUA granted by the FDA |
Gilead Sciences | remdesivir | patients 12 years and older with a body weight of at least 40 kg with severe symptoms of COVID-19 who have pneumonia and require extra oxygen to help them breathe | approved by Health Canada |
Other Trials and Actions | |||
4-D Molecular Therapeutics | 4D-110 | choroideremia | dosing of first patient in phase 1 trial |
Chi-Med | HMPL-306 | hematological malignancies | initiation of phase 1 trial |
Cleave Therapeutics | CB-5339 | patients with relapsed/refractory acute myeloid leukemia or relapsed/refractory intermediate or high-risk myelodysplastic syndrome | dosing of first patient in phase 1 trial |
Pipeline Therapeutics | PIPE-505 | sensorineural hearing loss associated with hearing speech in noisy environments | initiation of phase 1/2a trial |
Repare Therapeutics | RP-3500 | solid tumors with specific genome instability-related genomic alterations including those in ATM gene | dosing of first patient in phase 1/2 trial |
Acurx Pharmaceutical | ibezapolstat | clostridioides difficile Infection | initiation of phase 2 trial |
Amgen Arrowhead |
AMG 890 | patients with elevated levels of lipoprotein (a) (Lp(a)) | initiation of phase 2 trial |
Iterion Therapeutics | tegavivint | desmoid tumors | enrollment of first patients in phase 2a trial |
NGM Biopharma | NGM621 | patients with geographic atrophy secondary to age-related macular degeneration | initiation of phase 2 trial |
Corcept Therapeutics | relacorilant combined with nab-paclitaxel (Abraxane) | metastatic, platinum-resistant ovarian cancer | patient enrollment complete in phase 2 trial |
Corcept Therapeutics | relacorilant | Cushing’s syndrome caused by adrenal adenomas or hyperplasia | enrollment of first patient in phase 3 trial |
Krystal Biotech | beremagene geperpavec (KB103) | dystrophic epidermolysis bullosa | initiation of phase 3 trial |
Carisma Therapeutics | CT-0508 | recurrent or metastatic HER2 overexpressing solid tumors after failure of approved HER2 targeted agents | IND approved by the FDA |
NeoImmuneTech | NT-I7 (efineptakin alfa) | patients with locally recurrent squamous cell carcinoma of head and neck undergoing salvage surgery | IND approved by the FDA |
Momenta Pharmaceuticals | nipocalimab | prevention of hemolytic disease of the fetus and newborn | Rare Pediatric Disease designation and Orphan Drug designation granted by the FDA |
Protara Therapeutics | TARA-002 | lymphatic malformations | Rare Pediatric Disease designation granted by the FDA |
Imara | IMR-687 | beta-thalassemia | Rare Pediatric Disease designation and Fast Track designation granted by the FDA |
Black Diamond Therapeutics | BDTX-189 | adult patients with solid tumors harboring an allosteric HER2 mutation or an EGFR or HER2 Exon 20 insertion mutation who have progressed following prior treatment and who have no satisfactory treatment options | Fast Track designation granted by the FDA |
Checkmate Pharmaceuticals | CMP-001 in combination with nivolumab or pembrolizumab | initial treatment of patients with unresectable Stage III or Stage IV melanoma to prolong the time to disease progression and treatment of patients with unresectable or metastatic melanoma refractory to prior anti-PD-1 blockade to improve the overall tumor response rate | Fast Track designation granted by the FDA |
Sarepta Therapeutics | SRP-9001 (AAVrh74.MHCK7.micro-dystrophin) | Duchenne Muscular Dystrophy | Fast Track designation granted by the FDA |
Inovio | INO-3107 | recurrent respiratory papillomatosis | Orphan Drug designation granted by the FDA |
Merus N.V. | Zenocutuzumab | pancreatic cancer | Orphan Drug designation granted by the FDA |
Ocugen | OCU400 | RHO mutation-associated retinal degeneration | Orphan Drug designation granted by the FDA |
Regulus Therapeutics | RGLS4326 | autosomal dominant polycystic kidney disease | Orphan Drug designation granted by the FDA |
Vita Therapeutics | VTA-11 | Duchenne Muscular Dystrophy | Orphan Drug designation granted by the FDA |
Merck | MK-6482 | patients with von Hippel-Lindau disease-associated renal cell carcinoma with nonmetastatic RCC tumors less than three centimeters in size, unless immediate surgery is required | Orphan Drug designation and Breakthrough Therapy Drug designation granted by the FDA |
Takeda | pevonedistat | patients with higher-risk myelodysplastic syndromes | Breakthrough Therapy Drug designation granted by the FDA |
AstraZeneca | Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) | chronic obstructive pulmonary disease | approved by the FDA |
Kite Pharma/Gilead Sciences | Tecartus (brexucabtagene autoleucel) | relapsed or refractory mantle cell lymphoma | approved by the FDA |
Stratus Medical | Vesta RF Cannula | radiofrequency heat lesion procedures for the relief of pain | approved by the FDA |
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