Oramed Receives FDA Clearance for IND Application for Its Oral GLP-1 Analog Capsule
Oramed Pharmaceuticals Inc. (ORMP)
Last oramed pharmaceuticals inc. earnings: 4/6 04:46 pm
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Source: PR Newswire
NEW YORK, Sept. 17, 2018 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for human trials of its oral GLP-1 analog capsule ORMD-0901.Glucagon-like peptide (GLP-1) analogs, which mimic the natural GLP-1 hormone in the body, are used in the treatment of type 2 diabetes and currently only available via injection. In a prior Phase 1 study on type 2 diabetic patients, Oramed's ORMD-0901 capsule was well tolerated and showed encouraging efficacy, including reducing blood sugar levels following a standard meal as compared to a placebo.Oramed's planned Phase 1 pharmacokinetic (PK) study is a fully-randomized, single-blind, placebo-controlled 4-way crossover study which will evaluate safety in addition to the pharmacokinetics of ORMD-
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- 5/9/24 - Form 10-Q
- 5/6/24 - Form 8-K
- 4/18/24 - Form 4
- ORMP's page on the SEC website