Rejuva

Rejuva
Gene therapy
VectorAAV9
Delivery methodInjection[1]

Rejuva is a gene therapy which is under development for the treatment of obesity and diabetes.[2][1][3][4][5] It is an adeno-associated virus (AAV)-based gene therapy which involves an engineered variant of human insulin promotor and which aims to permanently increase nutrient-responsive secretion glucagon-like peptide-1 (GLP-1) by pancreatic β-cells.[1][3][5] The therapy is administered via a 25-gauge needle delivery system guided by endoscopic ultrasound in a one-time outpatient treatment.[1][4] It is intended as a permanent alternative to GLP-1 agonists like semaglutide.[5][4] Rejuva is under development by Fractyl Health and is in the preclinical research stage of development.[2][3][4]

References

  1. 1 2 3 4 Simons M, Sharaiha RZ (February 2024). "Updates in metabolic bariatric endoscopy". Digestive Endoscopy. 36 (2): 107–115. doi:10.1111/den.14633. PMID 37405807. Rejuva (Fractyl, Lexington, MA) is an adeno-associated virus (AVV)- based gene therapy platform aimed to enable production of therapeutic proteins by the pancreas. The pancreas is accessed via endoscopic ultrasound using a 25-gauge needle delivery system. A feasibility and safety study in Yucatan pig model was presented at Digestive Disease Week 2023. Results showed activity of the AAV in up to 80% of the cells targeted. There were no procedure related pancreatitis events; however, pancreatic inflammation was seen at 3 weeks.30 Although in its infancy, extraluminal/pancreatic gene therapy is a promising area of research for the treatment and management of diabetes.
  2. 1 2 "Delving into the Latest Updates on Rejuva with Synapse". Synapse. 2 November 2024. Retrieved 24 January 2026.
  3. 1 2 3 Chatterjee R, Galave VS, Jindal AB (December 2025). "Current status of Liraglutide delivery systems for the management of type 2 diabetes mellitus". Drug Delivery and Translational Research. 15 (12): 4479–4500. doi:10.1007/s13346-025-01965-y. PMID 40914786. Recently, Fractyl health launched a more "smart" gene therapy initiative in order to substitute traditional pharmacotherapy. This technique involves an engineered variant of human insulin promotor along with targeted trafficking signals to enable nutrient-responsive secretion of GLP-1 from transduced pancreatic β-cells [186]. [...] 186. Health F. Fractyl Health Advances Rejuva® Gene Therapy Platform with Submission of First Clinical Trial Application Module in Europe for RJVA-001 in Type 2 Diabetes, 2025. [Online]. Available: www.fractyl.com.
  4. 1 2 3 4 Johnson M (20 November 2025). "Weight loss drugs help combat obesity, but what's the next step to better health?". NBC Boston. Today, the lab at Fractyl is focused on what could come next — including a potential one-time treatment designed to eliminate the need for lifelong GLP-1 injections. One candidate, known as Rejuva, aims to prompt the pancreas to naturally produce GLP-1 as needed. "A one-time administration — a 10-minute outpatient procedure — and for the rest of your life the cells in your pancreas would make a natural GLP-1 hormone as much as the body needs it," Rajagopalan said. Rejuva remains in the preclinical stage and is years away from consumer availability. But another Fractyl therapy, Revita, a gut-lining procedure that resets how the body signals sugar and fat processing, is already available in parts of Europe. It awaits further data and regulatory approval in the United States.
  5. 1 2 3 Baxter A (10 February 2025). "Beyond GLP-1s? This biotech is exploring longer-term metabolic treatments". PharmaVoice. Retrieved 24 January 2026.
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