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Pipeline
Company | Drug/Device | Medical Condition | Status |
---|---|---|---|
pharmaceutical-grade L-glutamine (PGLG) |
diverticulosis |
Phase 1 trial initiated enrolling 10 patients at multiple sites |
|
EDP-514 |
hepatitis B virus (HBV) |
Phase 1a/1b trial initiated enrolling 98 subjects |
|
KL1333 |
mitochondrial disease |
Phase 1a/1b trial initiated enrolling healthy subjects in the UK after successful completion of the first stage of enrollment |
|
AM-201 |
antipsychotic-induced weight gain and somnolence |
Phase 1b trial initiated enrolling healthy volunteer subjects in Europe |
|
MRx-4DP0004 |
asthma |
Phase 1/2 trial initiated enrolling 90 subjects not adequately controlled on their current inhaler maintenance therapy |
|
VE416 |
peanut allergy |
Phase 1b/2 trial initiated enrolling 40 subjects 12 years of age and older at MassGeneral Hospital for Children in Boston |
|
AG019 |
early-onset type 1 diabetes (T1D) |
Phase 1b/2a trial initiated enrolling subjects 12 to 17 years of age |
|
AG019 combined with teplizumab (PRV-031) |
early-onset type 1 diabetes (T1D) |
Phase 1b/2a trial initiated enrolling adult subjects |
|
rimegepant |
treatment refractory trigeminal neuralgia |
Phase 2 trial initiated enrolling subjects at Johns Hopkins Medical Center |
|
otilimab |
moderate to severe rheumatoid arthritis (RA) |
Phase 3 trial initiated |
|
M-001 |
influenza |
Phase 3 trial initiated |
|
SOLIRIS (eculizumab) |
neuromyelitis optica spectrum disorder (NMOSD) in adult subjects who are anti-aquaporin-4 (AQP4) antibody positive |
Approval granted by the FDA |
|
DARZALEX (daratumumab) in combination with lenalidomide and dexamethasone (Rd) |
subjects with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT) |
Approval granted by the FDA |
|
ZIRABEV (bevacizumab-bvzr) |
metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal cell carcinoma (RCC); and persistent, recurrent or metastatic cervical cancer |
Approval granted by the FDA |
|
Darzalex (daratumumab) in combination with lenalidomide and dexamethasone as a first-line treatment |
multiple myeloma subjects who are ineligible for autologous stem cell transplant (ASCT) |
Approval granted by the FDA |
|
Soliris (eculizumab) |
neuromyelitis optica spectrum disorder (NMOSD) in adult subjects that express a specific biomarker |
Approval granted by the FDA |
|
1% Sodium Hyaluronate |
osteoarthritis (OA) of the knee in subjects who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e.g., acetaminophen) |
Approval granted by the FDA |
|
Thiola EC (tiopronin) 100 mg and 300 mg tablets |
cystinuria |
Approval granted by the FDA |
|
Xembify 20% subcutaneous immunoglobulin |
primary immunodeficiencies |
Approval granted by the FDA |
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