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Drug & Device Pipeline News
This week’s Pipeline features an Australian phase 1 trial approval for type 1 diabetes, a phase 1 trial initiation for Parkinson’s disease and an FDA drug approval for presbyopia.
Company | Drug/Device | Medical Condition | Status |
---|---|---|---|
Trials Authorized |
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CF-370 |
Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia |
IND for a phase 1 trial approved by the FDA |
|
TERN-701 |
Chronic myeloid leukemia |
IND for a phase 1 trial approved by the FDA |
|
CD38-SADA |
Relapsed/refractory non-Hodgkin lymphoma |
IND for a phase 1 trial approved by the FDA |
|
SAB-142 |
Type 1 diabetes |
Approval for a phase 1 trial granted by Australia’s regulatory authority |
|
SKG0106 gene therapy |
Neovascular age-related macular degeneration |
Approval for a phase 1/2a trial granted by China’s regulatory authority |
|
177Lu-SN201 |
Advanced cancer |
Approval for a phase 1/2a trial granted by Australia’s regulatory authority |
|
NTLA-2001 gene therapy |
Transthyretin (ATTR) amyloidosis with cardiomyopathy |
IND for a phase 3 trial approved by the FDA |
|
APG-2575 plus acalabrutinib |
Chronic lymphocytic leukemia/small lymphocytic lymphoma in patients previously treated with a BTKi |
Approval for a phase 3 trial granted by China’s regulatory authority |
|
ProtEmbo Cerebral Embolic Protection System |
Transcatheter aortic valve replacement |
IDE approved by the FDA |
|
Trials Initiated |
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BMF-500 |
Relapsed/refractory acute leukemia |
Initiation of a phase 1 trial |
|
FX-909 |
Advanced urothelial carcinoma |
Initiation of a phase 1 trial |
|
HanAll BioPharma |
HL192 |
Parkinson’s disease |
Initiation of a phase 1 trial |
KO-2806 |
Advanced solid tumors |
Initiation of a phase 1 trial |
|
68Ga-R8760 |
Adrenocortical carcinoma |
Initiation of a phase 1 trial |
|
BL-B01D1 |
Metastatic/unresectable non-small cell lung cancer |
Initiation of a phase 1 trial |
|
NM26 |
Moderate-to-severe atopic dermatitis |
Initiation of a phase 1a/1b trial |
|
ATX-304 |
Cardiometabolic diseases |
Initiation of a phase 1b trial |
|
CLB-3000 vaccine |
Chronic hepatitis B |
Initiation of a phase 1b trial |
|
VRON-0200 |
Chronic hepatitis B |
Initiation of a phase 1b trial in Hong Kong and New Zealand |
|
BDC-3042 |
Metastatic/unresectable triple-negative breast cancer, colorectal cancer, clear cell renal cell carcinoma, head and neck cancer, non-small cell lung cancer, and ovarian cancer |
Initiation of a phase 1/2 trial |
|
IMNN-001 plus bevacizumab |
Advanced ovarian cancer |
Initiation of a phase 1/2 trial |
|
CTO1681 |
Cytokine release syndrome in lymphoma patients receiving CAR T-cell therapy |
Initiation of a phase 1b/2a trial |
|
Samuraciclib plus elacestrant |
CDK4/6i resistant HR+, HER2- metastatic breast cancer |
Initiation of a phase 2 trial |
|
CYR-064 |
Post-viral hyposmia |
Initiation of a phase 2 trial |
|
INB-400 |
Newly diagnosed glioblastoma multiforme |
Initiation of a phase 2 trial |
|
Froniglutide |
Dermatomyositis/polymyositis |
Initiation of a phase 2 trial in South Korea |
|
IMG-007 |
Alopecia areata |
Initiation of a phase 2a trial |
|
Olverembatinib plus chemotherapy |
Philadelphia chromosome-positive acute lymphoblastic leukemia |
Initiation of a phase 3 trial |
|
FP-001 |
Central precocious puberty |
Initiation of a phase 3 trial |
|
Approvals |
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Xphozah (tenapanor) |
Hyperphosphatemia in adults with chronic kidney disease on dialysis |
Approved by the FDA |
|
Keytruda (pembrolizumab)
|
Resectable (tumors ≥4 centimeters or node positive) non-small cell lung cancer |
Approved by the FDA for expanded indication |
|
Qlosi (pilocarpine hydrochloride ophthalmic solution) 0.4 percent |
Presbyopia |
Approved by the FDA |
|
Velsipity (etrasimod) |
Moderately-to-severely active ulcerative colitis |
Approved by the FDA |
|
Braftovi (encorafenib) plus Mektovi (binimetinib) |
Metastatic non-small cell lung cancer with a BRAF V600E mutation |
Approved by the FDA for new indication |
|
Bimzelx (bimekizumab-bkzx) |
Moderate-to-severe plaque psoriasis |
Approved by the FDA |
|
Zilbrysq (zilucoplan) |
AChR antibody-positive generalized myasthenia gravis in adults |
Approved by the FDA |
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14Apr