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A Phase I/IIa, Dose Escalation Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of Intraductal Administration of RXRG001 to Parotid Gland(s) in Adults With Radiation-Induced Xerostomia and Hyposalivation

Trial Profile

A Phase I/IIa, Dose Escalation Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of Intraductal Administration of RXRG001 to Parotid Gland(s) in Adults With Radiation-Induced Xerostomia and Hyposalivation

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 11 Sep 2026

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At a glance

  • Drugs RXRG 001 (Primary)
  • Indications Xerostomia
  • Focus Adverse reactions; First in man
  • Acronyms SPRINX-1
  • Sponsors Riboxx Pharmaceuticals

Most Recent Events

  • 08 Sep 2026 According to a RiboX Therapeutics media release, based on the data from the trial, the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to RXRG001 for the treatment of radiation-induced xerostomia (RIX) and hyposalivation.
  • 09 Mar 2025 According to a RiboX Therapeutics media release, the first patient was dosed last week in this trial
  • 06 Mar 2025 Status changed from not yet recruiting to recruiting.

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