TB-500 FDA PCAC Review: What the Preclinical Record Shows A research-focused summary of the preclinical evidence for TB-500 (Thymosin Beta-4 fragment) ahead of the July 2026 FDA PCAC 503A review covering angiogenesis, tissue repair, cardiac models, and what the evidentiary record means for the committee
J Diabetes Complicat 27(1):7881
Additional serious risks include: Acute pancreatitis severe, persistent abdominal pain radiating to the back requires immediate medical attention Gallbladder disease rapid weight loss from any cause increases gallstone risk Acute kidney injury secondary to dehydration from vomiting/diarrhoea Hypoglycaemia increased risk when combined with insulin or sulfonylureas Aspiration risk during surgery delayed gastric emptying may require pre-operative fasting adjustments Contraindications Who Should Not Take Foundayo Orforglipron is contraindicated in patients with: Personal or family history of medullary thyroid carcinoma (MTC) Multiple Endocrine Neoplasia syndrome type 2 (MEN2) Pregnancy or planned pregnancy (discontinue at least 2 months before planned conception) Severe gastrointestinal disease including gastroparesis History of pancreatitis Type 1 diabetes Prior serious hypersensitivity reactions to any GLP-1 receptor agonist Critically, orforglipron should not be combined with other GLP-1 receptor agonists including Ozempic, Wegovy, Mounjaro, Zepbound, Saxenda, or Rybelsus
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Besides gastrointestinal issues, dulaglutide can also cause fatigue, injection site reactions (redness, itching, or swelling at the injection point), and dizziness
