Cingulate Inc. Announces FDA Acceptance of CTx-1301 NDA

Strategic Insights -

Cingulate Inc. has filed a Form 8-K with the SEC on October 14, 2025, disclosing that the FDA has accepted for review the New Drug Application (NDA) for CTx-1301 (dexmethylphenidate), the company's lead candidate for the treatment of attention deficit/hyperactivity disorder (ADHD) in children and adults. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026. This development marks a significant milestone for Cingulate Inc. as it progresses towards potential approval and commercialization of its lead candidate.

Key Takeaways:

  • Cingulate Inc. has filed a Form 8-K with the SEC on October 14, 2025, disclosing FDA acceptance of the NDA for CTx-1301.
  • The FDA has assigned a PDUFA target action date of May 31, 2026, for the review of CTx-1301.
  • CTx-1301 is Cingulate Inc.'s lead candidate for the treatment of ADHD in children and adults.
  • The NDA acceptance is a critical milestone for Cingulate Inc. as it progresses towards potential approval and commercialization of CTx-1301.
  • The company's CEO and CFO, Jennifer L. Callahan, is authorized to act on behalf of the company in this matter.
  • The company has also announced the FDA acceptance of the NDA for CTx-1301 in a press release dated October 14, 2025.

Statistics:

  • The FDA has assigned a PDUFA target action date of May 31, 2026, for the review of CTx-1301.
  • The NDA acceptance for CTx-1301 marks a crucial milestone for Cingulate Inc. as it aims to commercialize a new treatment for ADHD.
  • The company's lead candidate, CTx-1301, has the potential to address a significant unmet need in the treatment of ADHD in children and adults.

Sources:

  • UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT, October 14, 2025.
  • Press release dated October 14, 2025, accompanying Form 8-K filing.