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.
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Lipogems completes patient enrolment in ARISE I US FDA IDE study
Amylyx Pharmaceuticals' AMX0035 shows promising impact on Wolfram syndrome symptoms
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
Seres Therapeutics completes patient enrollment for SER-155 Phase 1B trial
Syros receives Fast Track Designation from FDA for tamibarotene in AML
Ligand Pharmaceuticals announces presentation of Captisol-enabled Topiramate Injection data
Enhertu receives FDA approval for HER2+ solid tumours
Dizal's sunvozertinib receives US FDA Breakthrough Therapy Designation
Lipogems enrols first patient in ARISE II US FDA IDE research study