Cingulate's Drug in the FDA Approval Process
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:
- June 2, 2026
- Indication:
- Attention Deficit/Hyperactivity Disorder (ADHD)
Announcement
Cingulate Inc. announced that the U.S. Food and Drug Administration ("FDA") has issued a Complete Response Letter for its New Drug Application ("NDA") for CTx-1301 (dexmethylphenidate HCl) for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD).
AI Summary
Cingulate Inc. said the U.S. Food and Drug Administration has issued a Complete Response Letter for its New Drug Application for CTx-1301, a treatment for attention-deficit/hyperactivity disorder (ADHD). The company said the FDA’s feedback was mainly focused on Chemistry, Manufacturing and Controls, or CMC, information requests. Importantly, Cingulate said the agency did not identify any current concerns about the drug’s clinical safety or effectiveness.
The company plans to respond quickly and submit the requested information to address the FDA’s questions. Cingulate also noted that it remains financially strong, with nearly $30 million in cash on hand. The company said it is working to move the review process forward as soon as possible.
Read Announcement- Drug:
- CTx-1301
- Announced Date:
- October 28, 2025
- Indication:
- Attention Deficit/Hyperactivity Disorder (ADHD)
Announcement
Cingulate Inc. announced today that the positive Phase 3 results from its pivotal trial of CTx-1301 (dexmethylphenidate HCl) in pediatric ADHD, were recently presented by Ann Childress, M.D., at the AACAP Annual Meeting in Chicago. CTx-1301 met its primary endpoint, demonstrating dose-dependent improvements on the ADHD ratings scale 5 (ADHD-RS-5), and Clinical Global Impression-Severity (CGI-S) scales, and demonstrated the ability to deliver symptom relief with the convenience of once-daily dosing.
AI Summary
Cingulate Inc. announced that positive Phase 3 results for CTx-1301 (dexmethylphenidate HCl) in pediatric ADHD were presented by Ann Childress, M.D., at the AACAP Annual Meeting in Chicago. In this pivotal trial, CTx-1301 met its primary endpoint by showing dose-dependent improvements on the ADHD Rating Scale-5 (ADHD-RS-5) and the Clinical Global Impression-Severity (CGI-S) scale. The study highlighted the ability to deliver reliable symptom relief with once-daily dosing.
The randomized, double-blind, placebo-controlled trial in children and adolescents demonstrated a rapid onset of effect and sustained efficacy through the evening hours. Safety and tolerability were in line with other stimulant medications, and no unexpected adverse events were reported.
Dr. Childress noted that the 37.5 mg dose produced the largest effect size in symptom reduction, even under forced-dose conditions. She added that the safety profile resembled that of existing methylphenidate products, with no new concerns.
By offering effective, once-daily relief, CTx-1301 could simplify ADHD management and improve adherence for patients and their families.
Read Announcement- Drug:
- CTx-1301
- Announced Date:
- October 23, 2025
- Indication:
- Attention Deficit/Hyperactivity Disorder (ADHD)
Announcement
Cingulate Inc announced that data from its lead ADHD candidate CTx-1301 (dexmethylphenidate HCl) has been selected for podium presentation at the American Academy of Child and Adolescent Psychiatry (AACAP) Annual Meeting in Chicago.
AI Summary
Cingulate Inc. announced that data from its lead ADHD treatment, CTx-1301 (dexmethylphenidate HCl), was selected for a podium presentation at the American Academy of Child and Adolescent Psychiatry Annual Meeting in Chicago. The meeting is a top event for child and adolescent psychiatry.
The data come from a Phase 3 trial of CTx-1301, a once-daily, extended-release tablet designed to give rapid symptom relief and full-day coverage. Dr. Ann Childress, a renowned ADHD specialist, will present the findings on October 24, 2025, under the title “Efficacy and Safety of CTx-1301 in Pediatric Subjects With ADHD.”
Dr. Childress said the trial results offer valuable insights into how CTx-1301 can simplify treatment with convenient once-daily dosing. Raul Silva, Chief Science Officer at Cingulate, added that selection for an AACAP podium highlights the rigorous science behind the therapy and its potential to overcome current stimulant limitations like delayed onset and inconsistent duration.
Read Announcement- Drug:
- CTx-1301
- Announced Date:
- October 14, 2025
- Target Action Date:
- May 31, 2026
- Indication:
- Attention Deficit/Hyperactivity Disorder (ADHD)
Announcement
Cingulate Inc. announced that The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026.
AI Summary
Cingulate Inc. is developing CTx-1301, a once-daily stimulant tablet for treating ADHD in children and adults. The drug uses the company’s Precision Timed Release™ (PTR™) platform to deliver three timed doses of dexmethylphenidate, aiming to provide fast symptom relief and coverage throughout the day.
The U.S. Food and Drug Administration has set a Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026, for CTx-1301. The application is being reviewed under the 505(b)(2) pathway, which lets Cingulate leverage existing safety data on dexmethylphenidate while presenting its novel drug-delivery design.
This PDUFA date marks a crucial regulatory milestone for Cingulate. If approved, CTx-1301 could address common ADHD treatment gaps—like midday symptom rebound and dosing challenges—and support the company’s transition toward commercialization and supplying a new, patient-friendly option in 2026.
Read Announcement- Drug:
- CTx-1301
- Announced Date:
- October 14, 2025
- Indication:
- Attention Deficit/Hyperactivity Disorder (ADHD)
Announcement
Cingulate Inc. announced that the U.S. Food and Drug Administration (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.
AI Summary
Cingulate Inc. announced that the U.S. Food and Drug Administration has accepted for review its New Drug Application for CTx-1301, a once-daily precision timed-release stimulant designed to treat ADHD in children and adults. CTx-1301 uses a multi-core tablet to deliver rapid symptom relief and maintain effect throughout the active day.
The application was filed under the FDA’s 505(b)(2) pathway, allowing Cingulate to reference existing dexmethylphenidate data while showing the novel benefits of its delivery system. The FDA set a Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026. Acceptance of the NDA means the submission is complete and ready for full review.
CTx-1301 completed adult and pediatric Phase 3 trials, showing large improvements in key ADHD measures and no serious treatment-related adverse events. With formal review now underway, Cingulate is preparing for a potential 2026 commercial launch pending approval.
Read Announcement- Drug:
- CTx-1301
- Announced Date:
- August 6, 2025
- Indication:
- Attention Deficit/Hyperactivity Disorder (ADHD)
Announcement
Cingulate announced that it has submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for CTx-1301(dexmethylphenidate HCl), the company's lead asset for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD).
AI Summary
Cingulate Inc. announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for CTx-1301 (dexmethylphenidate HCl), its leading treatment for Attention Deficit/Hyperactivity Disorder (ADHD). This marks a key milestone for the company as it moves toward potential U.S. approval.
CTx-1301 is a novel, extended-release tablet that uses Cingulate’s Precision Timed Release™ platform. It is designed to deliver a quick start, all-day symptom control, and a smooth drug profile with just one daily dose. The goal is to address gaps in current ADHD therapies, such as uneven effect and multiple daily dosing.
Cingulate expects to learn within 60 days whether the FDA has accepted the NDA for review. Company leaders believe CTx-1301 could improve patient outcomes across ages and capture significant share in the $23 billion U.S. ADHD market if approved.
Read Announcement- Drug:
- CTx-1301
- Announced Date:
- July 29, 2025
- Indication:
- Attention Deficit/Hyperactivity Disorder (ADHD)
Announcement
Cingulate Inc. announced that it has received a fiscal year 2025 PDUFA (Prescription Drug User Fee Act) fee waiver from the U.S. Food and Drug Administration (FDA) for its new drug application (NDA) for lead asset CTx-1301 (dexmethylphenidate HCI) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
AI Summary
Cingulate Inc. announced it has received a fiscal year 2025 PDUFA fee waiver from the U.S. Food and Drug Administration for its new drug application (NDA) for CTx-1301 (dexmethylphenidate HCl), an ADHD treatment. This waiver was granted under the small business provision of the Federal Food, Drug, and Cosmetic Act.
The waiver will save Cingulate approximately $4.3 million as the company finalizes its NDA submission at the end of the month. CTx-1301 uses Cingulate’s Precision Timed Release™ (PTR™) platform to deliver three precise doses of dexmethylphenidate in one tablet. This design aims to provide rapid onset and full-day symptom control with a single daily pill.
“We are pleased to receive this significant waiver as we approach the submission of our NDA and look forward to continuing to work with the FDA throughout the review process,” said Cingulate CEO Shane J. Schaffer. He added that the fee savings will strengthen the company’s financial position as it prepares to commercialize CTx-1301.
Read Announcement- 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
- Target Action Date:
- H1 2025
- Estimated Target Date Range:
- January 1, 2025 - June 30, 2025
- 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
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 June 2, 2026, involving CTx-1301. The update was categorized as "Complete Response Letter," with the company reporting: "Cingulate Inc. announced that the U.S. Food and Drug Administration ("FDA") has issued a Complete Response Letter for its New Drug Application ("NDA") for 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).
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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
FDA progress for NASDAQ:CING last updated on 6/2/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
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