FDA Events for Cingulate (CING)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Cingulate (CING).
Over the past two years, Cingulate has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
CTx-1301. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
CTx-1301 - FDA Regulatory Timeline and Events
CTx-1301 is a drug developed by Cingulate for the following indication: Attention Deficit/Hyperactivity Disorder (ADHD).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CTx-1301
- Announced Date:
- May 20, 2025
- Indication:
- Attention Deficit/Hyperactivity Disorder (ADHD)
Announcement
Cingulate announced the efficacy results from an FDA required Phase 3, randomized, fixed dose, double blind, placebo controlled clinical study in pediatrics (aged 6-17), for its lead asset CTx-1301 (dexmethylphenidate HCl) for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD).
AI Summary
Cingulate Inc. announced positive efficacy results from an FDA-required Phase 3 clinical study evaluating its lead asset, CTx‑1301 (dexmethylphenidate HCl), for treating ADHD in pediatric patients aged 6–17. This randomized, fixed-dose, double-blind, and placebo-controlled study used fixed doses of 18.75 mg, 25 mg, and 37.5 mg. Within five weeks, subjects in all dose groups showed statistically significant improvements in ADHD symptoms, as measured by the ADHD‑RS‑5 rating scale. Effect sizes ranged from 0.737 at the lowest dose to 1.185 at the highest dose, demonstrating robust efficacy.
If approved by the FDA, CTx‑1301 is expected to become an important treatment option for ADHD, addressing longstanding unmet needs. The study’s positive findings underscore the potential of Cingulate’s innovative Precision Timed Release drug delivery platform to offer reliable, once-daily dosing for pediatric patients.
Read Announcement- Drug:
- CTx-1301
- Announced Date:
- May 14, 2025
- Indication:
- Attention Deficit/Hyperactivity Disorder (ADHD)
Announcement
Cingulate Inc. announced that it has received formal pre-New Drug Application (NDA) meeting minutes from the U.S. Food and Drug Administration (FDA) for it's lead asset CTx-1301 (dexmethylphenidate) for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD).
AI Summary
Cingulate Inc. recently announced that it has received formal pre-New Drug Application (NDA) meeting minutes from the U.S. Food and Drug Administration (FDA) for its lead asset, CTx-1301 (dexmethylphenidate), intended for treating Attention Deficit/Hyperactivity Disorder (ADHD). The FDA’s minutes provided feedback that aligns with Cingulate’s plans to file its NDA this summer. In these discussions, the FDA agreed to a post-NDA commitment to collect additional stability data for six intermediate dose strengths and noted that current nonclinical safety data is adequate to support a filing. Furthermore, it found the company’s proposed approach to the integrated safety and efficacy summaries reasonable. CTx-1301 utilizes a Precision Timed Release technology that aims to deliver medication in three timed releases, providing a full day of symptom control, and positioning the drug as the first true once-daily stimulant for ADHD.
Read Announcement- Drug:
- CTx-1301
- Announced Date:
- April 29, 2025
- Indication:
- Attention Deficit/Hyperactivity Disorder (ADHD)
Announcement
Cingulate Inc announced positive top-line results from the CTx-1301-013 study, an FDA required study, assessing the effect of food on absorption of the highest dose (50mg) of its lead candidate CTx-1301.
AI Summary
Cingulate Inc. announced positive top-line results from its FDA-required CTx-1301-013 study, which evaluated whether food affects the absorption of its highest 50mg dose of CTx-1301, a novel treatment for ADHD. The study involved 27 healthy adults who received the medication both with a standard high-fat breakfast and on an empty stomach. Key pharmacokinetic measurements—including the peak plasma concentration and the overall drug exposure—demonstrated that food does not impact the absorption of the 50mg dose. This means that CTx-1301 can be taken with or without food, offering simplicity and consistency in dosing.
The results confirm that the formulation of 50mg CTx-1301 is optimal for providing full-day coverage for ADHD symptoms. These findings support further development and future presentations, with hopes of improving ADHD management through a true once-daily stimulant treatment.
Read Announcement- Drug:
- CTx-1301
- Announced Date:
- April 3, 2025
- Indication:
- Attention Deficit/Hyperactivity Disorder (ADHD)
Announcement
Cingulate announced that it held a Pre-NDA meeting with the U.S. Food and Drug Administration (FDA) yesterday to discuss the submission of a new drug application (NDA) for its lead Phase 3 asset CTx-1301 (dexmethylphenidate HCl) for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD).
AI Summary
Cingulate Inc. held a Pre-NDA meeting with the U.S. Food and Drug Administration (FDA) to discuss its upcoming submission of a new drug application (NDA) for its lead Phase 3 product, CTx-1301 (dexmethylphenidate HCl), which is intended to treat Attention Deficit/Hyperactivity Disorder (ADHD). The company, known for its proprietary Precision Timed Release (PTR™) drug delivery platform, reported that the meeting was very productive. During the discussions, the FDA provided valuable insights that will guide the NDA filing planned for mid-2025. This milestone reinforces Cingulate’s mission to introduce the first true once-daily stimulant medication designed to offer therapeutic benefits throughout the active day, potentially improving treatment outcomes for ADHD patients.
Read Announcement- Drug:
- CTx-1301
- Announced Date:
- March 4, 2025
- Indication:
- Attention Deficit/Hyperactivity Disorder (ADHD)
Announcement
Cingulate Inc today released Phase 3 safety data for its lead asset CTx-1301 (dexmethylphenidate) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
AI Summary
Cingulate Inc has released Phase 3 safety data for its lead asset, CTx-1301 (dexmethylphenidate), a novel once-daily stimulant designed to treat ADHD throughout the active day. The data comes from two pediatric and adolescent trials—a fixed dose study and a dose optimization study—as well as a separate food effect study in healthy adults using a 50mg dose. The comprehensive results demonstrate a stable safety profile with no serious adverse events or treatment-related deaths. Importantly, the studies confirmed that CTx-1301 can be taken with or without food while providing continuous therapeutic effects, potentially reducing the need for additional dosing and lowering risks such as crashes or rebound symptoms.
The safety findings, consistent across multiple trials, have been submitted to the FDA ahead of an in-person Pre-NDA meeting scheduled for April 2, 2025, paving the way for the product’s upcoming new drug application submission.
Read Announcement- Drug:
- CTx-1301
- Announced Date:
- January 7, 2025
- Estimated Event Date Range:
- January 1, 2025 - June 30, 2025
- Target Action Date:
- 2025-H1
- Indication:
- Attention Deficit/Hyperactivity Disorder (ADHD)
Announcement
Cingulate Inc announced that Submission of New Drug Application Targeted for Mid 2025
AI Summary
Cingulate Inc announced that it has completed the final FDA-required food effect study for its lead drug candidate, CTx-1301, designed to treat ADHD. In this study, 26 healthy adults received a single 50mg dose in both fed and fasted states, and no serious adverse events were reported. The trial is a key step to verify that the medication works effectively regardless of food intake by checking how it is absorbed in the body.
The successful completion of this study is one of the last steps before Cingulate submits a New Drug Application (NDA) to the FDA, a submission they are targeting for mid-2025. The company’s approach aims to provide a once-daily stimulant medication with a full active-day duration using its Precision Timed Release (PTR) platform.
Read Announcement- Drug:
- CTx-1301
- Announced Date:
- January 7, 2025
- Indication:
- Attention Deficit/Hyperactivity Disorder (ADHD)
Announcement
Cingulate Inc announced that it has completed its final FDA-required study, which is a food effect study, for CTx-1301 (dexmethylphenidate) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
AI Summary
Cingulate Inc. announced that it has completed its final FDA-required food effect study for CTx‑1301 (dexmethylphenidate), their lead candidate for treating Attention Deficit Hyperactivity Disorder (ADHD). The study tested a single 50mg dose of CTx‑1301 in healthy subjects under fed and fasted conditions. The aim was to determine whether food impacts the absorption and bioavailability of the medication. Results showed that there were no serious adverse events, indicating that CTx‑1301 could be safely taken with or without food. A detailed data readout regarding bioavailability is expected in the second quarter of 2025. This milestone is a significant step as the company finalizes the necessary clinical activities for its New Drug Application (NDA) submission to the FDA, which is targeted for mid‑2025.
Read Announcement- Drug:
- CTx-1301
- Announced Date:
- September 12, 2024
- Indication:
- Attention Deficit/Hyperactivity Disorder (ADHD)
Announcement
Cingulate Inc. announced that that it has commenced its final FDA-required study, which is a food effect study, for CTx-1301 (dexmethylphenidate) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
AI Summary
Cingulate Inc. has initiated its final FDA-required study for CTx-1301 (dexmethylphenidate), a new treatment for ADHD. This study, known as a food effect study, is designed to assess how food impacts the drug’s absorption at its highest dose. In the study, healthy adult volunteers will receive the medication under both fed and fasted conditions to understand its bioavailability. Cingulate expects to have the data from the study by the end of 2024, marking a critical step toward its planned New Drug Application (NDA) submission targeted for mid-2025. CTx-1301 leverages the company’s proprietary Precision Timed Release (PTR) technology, which delivers the drug in multiple timed releases throughout the day, potentially offering full-day symptom control for individuals with ADHD. This milestone brings the company closer to providing a more effective and controlled treatment option for ADHD patients.
Read Announcement- Drug:
- CTx-1301
- Announced Date:
- September 12, 2024
- Indication:
- Attention Deficit/Hyperactivity Disorder (ADHD)
Announcement
Cingulate Inc. announced that A data readout from the study is expected by the end of 2024.
AI Summary
Cingulate Inc. recently announced the start of its final FDA-required food effect study for its lead candidate, CTx-1301 (dexmethylphenidate), designed to treat Attention Deficit Hyperactivity Disorder (ADHD). This clinical study will investigate how food influences the absorption of the medication by comparing its effects under fed and fasted conditions. The data collected from the study is critical for understanding the drug’s bioavailability and will help support the company’s plans to submit a New Drug Application (NDA) by mid-2025. Cingulate expects to share a complete data readout from this study by the end of 2024, marking an important milestone in the development process of this innovative treatment approach.
Read Announcement - Drug:
- CTx-1301
- Announced Date:
- August 15, 2024
- Indication:
- Attention Deficit/Hyperactivity Disorder (ADHD)
Announcement
Cingulate Inc. announced that it was issued a European patent for its lead asset CTx-1301 (dexmethylphenidate) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
AI Summary
Cingulate Inc. announced that it has been granted a European patent for its leading drug candidate, CTx-1301 (dexmethylphenidate), designed to treat Attention Deficit Hyperactivity Disorder (ADHD). The patent, issued on August 14, 2024, under EP Patent No. 3261625, covers up to 30 European territories, including the United Kingdom. This milestone solidifies Cingulate’s commitment to advancing new treatments for ADHD using its innovative Precision Timed Release™ technology.
The company already holds patents in markets like Australia, Canada, and Israel, with additional applications pending in regions including Hong Kong, the Republic of Korea, and the United States. Cingulate sees this European patent as a significant step forward in expanding the reach of CTx-1301 and hopes to secure more patents soon, aiming to positively impact ADHD treatment markets in Europe and beyond.
Read Announcement- Drug:
- CTx-1301
- Announced Date:
- June 25, 2024
- Indication:
- Attention Deficit/Hyperactivity Disorder (ADHD)
Announcement
Cingulate Inc announced that that it has completed the manufacturing of its twelve registration batches for its lead asset CTx-1301 (dexmethylphenidate) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
AI Summary
Cingulate Inc. has successfully completed the manufacturing of its twelve required registration batches for its lead asset, CTx-1301 (dexmethylphenidate), which is being developed to treat Attention Deficit Hyperactivity Disorder (ADHD). These batches are produced using the same equipment, dosage strengths, and procedures that will be used in commercial production. Completing the registration batches is a key step in meeting U.S. Food and Drug Administration (FDA) requirements and demonstrates that the company’s manufacturing process is reliable and that the product maintains an acceptable shelf life.
This milestone brings Cingulate Inc. significantly closer to finalizing its new drug application (NDA), which is currently being prepared for submission. The company plans to file the NDA in the first half of 2025, marking an important advancement for their innovative treatment approach for ADHD.
Read Announcement- Drug:
- CTx-1301
- Announced Date:
- May 21, 2024
- Indication:
- Attention Deficit/Hyperactivity Disorder (ADHD)
Announcement
Cingulate Inc. announced that it has received confirmation from and is aligned with the U.S. Food and Drug Administration (FDA) on the requirements necessary for filing a New Drug Application (NDA) for its lead Phase 3 candidate CTx-1301 (dexmethylphenidate), for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients six years of age or older.
AI Summary
Cingulate Inc. recently confirmed with the U.S. Food and Drug Administration (FDA) that it is aligned on the requirements necessary to file a New Drug Application (NDA) for its lead Phase 3 candidate, CTx-1301 (dexmethylphenidate). This formulation is designed to treat Attention Deficit Hyperactivity Disorder (ADHD) in patients aged six years and older. The FDA has agreed that the NDA will follow the 505(b)(2) pathway, allowing Cingulate to include data from two Phase 3 studies—the fixed dose and onset/duration assessments—in the application. Additionally, a Phase 1 fed/fast study will be conducted concurrently and its results appended to the NDA filing. With this clear regulatory guidance, Cingulate is focused on finalizing the remaining requirements and plans to submit its application in the first half of 2025, paving the way for broader patient access.
Read Announcement
Cingulate FDA Events - Frequently Asked Questions
As of now, Cingulate (CING) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Cingulate (CING) has reported FDA regulatory activity for CTx-1301.
The most recent FDA-related event for Cingulate occurred on May 20, 2025, involving CTx-1301. The update was categorized as "Efficacy Data," with the company reporting: "Cingulate announced the efficacy results from an FDA required Phase 3, randomized, fixed dose, double blind, placebo controlled clinical study in pediatrics (aged 6-17), for its lead asset CTx-1301 (dexmethylphenidate HCl) for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD)."
Currently, Cingulate has one therapy (CTx-1301) targeting the following condition: Attention Deficit/Hyperactivity Disorder (ADHD).
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:CING) was last updated on 7/11/2025 by MarketBeat.com Staff
