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Crohns Disease: Special Considerations Crohns disease is a type of inflammatory bowel disease

GLP1 plus treatments go beyond GLP1RAs by combining GLP1 activity with complementary activities such as those of GIP, glucagon and amylin

FDA staff's own briefing document, posted publicly ahead of the meeting as part of the docket, proposes that TB-500 (free base) and TB-500 acetate not be added to the list, citing incomplete physicochemical characterization, a lack of evidence of effectiveness for wound healing (including an in-vitro fibroblast study in which TB-500 reportedly did not induce wound healing), and insufficient nonclinical and clinical safety data

Dermatologic: rash, erythema, pruritus CNS: headache, dizziness, agitation, anxiety Ophthalmic: diplopia 7