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The trial did not resume enrollment Preclinical cardiac evidence: Animal models of myocardial infarction demonstrated RGN-352 reduced scar volume, improved cardiac function, and increased survival, forming the basis for the clinical program (PMID: 25015963) RGN-259 (Thymosin Beta-4 Ophthalmic Solution for Dry Eye): ARISE-1 and ARISE-2 Phase 3 trials: Evaluated Thymosin Beta-4 eye drops for dry eye disease with mixed results some endpoints showed improvement in signs of dry eye, but the pre-specified co-primary endpoints were not met, though some secondary endpoints showed statistically significant improvements in certain signs of dry eye (PMID: 23050815) These ophthalmic trials represent the most advanced clinical testing of any Thymosin Beta-4 formulation Independent Pilot Study (China, 2016): A small pilot study randomized 10 STEMI (heart attack) patients into two groups: 5 receiving Thymosin Beta-4-pretreated endothelial progenitor cells (EPCs) and 5 receiving untreated EPCs After 6 months, the Thymosin Beta-4-pretreated group showed trends toward improved cardiac function markers including ejection fraction and exercise capacity, though the very small sample size (n=5 per group) means these results should be considered hypothesis-generating only, not evidence of efficacy (PMID: 27288307) No severe complications were reported in either group during follow-up Important: This study used Thymosin Beta-4 as a cell pretreatment agent ex vivo (EPCs exposed to TB4 before transplantation), not as a directly administered drug

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The FDA allows the compounding of certain drugs if the commercially available version is in a verified shortage , which they define as a period of time when the demand or projected demand for the drug within the United States exceeds the supply of the drug. Although there is no exact threshold, this decision is usually based on disruptions in manufacturing and distribution as well as unexpected demand surges

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