Gonadorelin Acetate, a peptide previously FDA approved as LutrePulse for the induction of ovulation in women with primary hypothalamic amenorrhea and sometimes used off label for conditions such as hypogonadism, has been added to the Category 1 list
no official package insert Clinical trial status / No completed Phase III trials in humans for TB-500 specifically Bulk drug substance status / Subject to ongoing FDA review for compounding eligibility DEA scheduling / TB-500 is not a controlled substance Key safety concern / No large-scale human safety data from randomized controlled trials Regulatory trend / FDA has increased scrutiny of peptide compounding since 2023 Parent molecule research / Thymosin beta-4 studied in wound healing and cardiac repair preclinical models TB-500 Has No FDA Approval TB-500 has never been submitted to or approved by the FDA through a New Drug Application (NDA) or Biologics License Application (BLA)
COMPOSITION Folic acid 15 mg/mL, Cyanocobalamin (Vit B 12) 500 ug/mL ACTIONS Supplementation of Folic Acid and Vitamin B12 INDICATIONS Folic Acid and Vitamin B12 supplement for the treatment of macrocytic anaemia in horses and dogs
Unmixed powder keeps best frozen or refrigerated and away from light
It can aid in the formation of new blood vessels, enhance collagen production, and reduce inflammation, all of which contribute to improved wound healing [8]
Patients should be educated about potential delayed signs and symptoms