The United States Food and Drug Administration (FDA) has approved Israel-based Oramed Pharmaceuticals Inc's (NASDAQ :ORMP)(TASE: ORMP) Investigational New Drug application (IND) for human trials of its oral GLP-1 analogue capsule ORMD-0901, it was reported yesterday.
The product is utilised in the treatment of type 2 diabetes and presently only offered through injection. In a prior Phase one study on type two diabetic patients, the company's ORMD-0901 capsule was well tolerated and indicated encouraging efficacy, including decreasing blood sugar levels following a standard meal as compared to a placebo.
The company's planned Phase one pharmacokinetic study is a fully-randomised, single-blind, placebo-controlled four-way crossover study that will assess safety in addition to the pharmacokinetics of ORMD-0901 compared to placebo and to open label Byetta, a GLP-1 analogue presently on the market, in up to 15 healthy subjects.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval