(Laduviglusib + valproic acid) is under clinical development by Frequency Therapeutics and currently in the Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect (Laduviglusib + valproic acid)’s likelihood of approval (LoA) and phase transition for Acute Sensorineural Hearing Loss took place on 12 Oct 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their (Laduviglusib + valproic acid) Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

(Laduviglusib + valproic acid) overview

FX-322 is under development for the treatment of chronic noise induced hearing loss or severe to profound sensorineural hearing loss. The drug candidate is administered through intratympanic route. It is developed based on progenitor cell activation (PCA) platform. The drug candidate is a combination of laduviglusib and valproic acid. Laduviglusib acts by targeting glycogen synthase kinase 3 alpha and beta inhibitor, valproic acid acts by targeting histone deacetylase (HDAC).

Frequency Therapeutics overview

Frequency Therapeutics is a biotechnology company that develops progenitor cell activation (PCA) therapies. The company’s small molecule drugs are used to activate progenitor cells for the restoration of healthy tissue. Its lead program FX-322 is used to recreate sensory cells of the inner ear to treat chronic noise, which induces hearing loss and is used to create new hair cells. Frequency Therapeutics products are used for muscle regeneration, gastrointestinal diseases, and skin disorders. The company also develops additional products through strategic alliances and internal development for skin disorders, muscle regeneration, and gastrointestinal diseases. Frequency Therapeutics is headquartered in Woburn, Massachusetts, the US.

Quick View (Laduviglusib + valproic acid) LOA Data

Report Segments
  • Innovator
Drug Name
  • (Laduviglusib + valproic acid)
Administration Pathway
  • Intratympanic
Therapeutic Areas
  • Ear Nose Throat Disorders
Key Developers
  • Sponsor Company: Frequency Therapeutics
Highest Development Stage
  • Phase II


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.