dexmethylphenidate tri-modal release (CTx-1301) / Cingulate Therap, BDD Pharma - LARVOL DELTA

Efficacy and Safety of CTx-1301 in Pediatric Subjects With ADHD: Results From a Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial (AACAP 2025) - "CTx-1301 significantly improved core ADHD symptoms in a dose-dependent manner, with the 37.5 mg dose producing the largest effect size and symptom reduction. Effect sizes are substantial considering that in a fixed-dose study, doses are not established by optimal therapeutic titration, rather by prespecified dosage protocol. The favorable safety and tolerability profile supports CTx-1301 as a promising once-daily treatment for pediatric ADHD.ADHD, ADOL, RCT"

Clinical • P3 data • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Pediatrics • Psychiatry

Cingulate Presents Positive Phase 3 Results for CTx-1301 Demonstrating Statistically Significant Efficacy and Entire Active-Day Symptom Control (The Manila Times) - "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."

P3 data • Attention Deficit Hyperactivity Disorder

FDA Accepts Cingulate’s New Drug Application for CTx-1301 in Attention-Deficit/Hyperactivity Disorder (ADHD) and sets a May 31, 2026 PDUFA Date (GlobeNewswire) - "The NDA submission follows completion of adult and pediatric Phase 3 trials, completion of all FDA-requested studies, and a positive pre-NDA meeting in April 2025 confirming adequacy of the clinical and Chemistry, Manufacturing, and Controls (CMC) data packages for review."

FDA filing • PDUFA • Attention Deficit Hyperactivity Disorder

Potential treatments for attention-deficit/Hyperactivity disorder: a focus on phase III trials. (PubMed, Expert Opin Pharmacother) - "Stimulant medications, such as methylphenidate and amphetamine derivatives, and non-stimulant medications, such as atomoxetine, guanfacine, clonidine, and viloxazine, are considered the cornerstones of pharmacological treatment for attention-deficit/hyperactivity disorder (ADHD)...We highlight four promising candidates: centanafadine, solriamfetol, CTx-1301, and NRCT-101SR...Additionally, multi-phase extended-release formulations may improve adherence and enhance symptom control throughout the day. As phase III data become available, these agents have the potential to redefine ADHD treatment paradigms."

Journal • P3 data • Review • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Cingulate Submits New Drug Application to FDA for Lead ADHD Asset CTx-1301 (GlobeNewswire) - "Cingulate Inc...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)."

FDA filing • Attention Deficit Hyperactivity Disorder

Fed-Fast: In-clinic Crossover Study in Subjects With Two Treatments (Fed vs Fasted) (clinicaltrials.gov) - P1 | N=25 | Completed | Sponsor: Cingulate Therapeutics

New P1 trial

Phase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301 (clinicaltrials.gov) - P3 | N=45 | Suspended | Sponsor: Cingulate Therapeutics | Trial completion date: Aug 2026 ➔ Mar 2026 | Trial primary completion date: Aug 2026 ➔ Mar 2026

Trial completion date • Trial primary completion date • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Pediatrics • Psychiatry

Phase 3 Efficacy and Safety Fixed-Dose Study in Pediatrics (6-17) With ADHD Using CTx-1301 (clinicaltrials.gov) - P3 | N=103 | Completed | Sponsor: Cingulate Therapeutics | Terminated ➔ Completed

Trial completion • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Pediatrics • Psychiatry

Cingulate Receives $4.3M Waiver from FDA Ahead of Imminent Filing for Marketing Approval of Lead ADHD Asset CTx-1301 (Yahoo Finance) - "Cingulate Inc...announced today 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). Granted through the small business waiver provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the waiver will save Cingulate approximately $4.3 million as the company prepares to submit its NDA at the end of this month."

FDA event • Attention Deficit Hyperactivity Disorder

FDA and Cingulate Aligned with Filing Requirements for New Drug Application for Lead ADHD Asset CTx-1301 (GlobeNewswire) - "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)....The agency agreed to a post-NDA approval commitment of additional stability date for the 6 intermediate dose strengths of 12.5-mg, 18.75-mg, 25-mg, 31.25-mg, 37.5-mg, and 43.75-mg....NDA Submission Planned this Summer."

FDA event • FDA filing • Attention Deficit Hyperactivity Disorder

Cingulate Announces Positive Top-Line Results from High-Dose (50mg) Fed/Fast Study of Lead Asset CTx-1301 for ADHD (GlobeNewswire) - P1 | N=27 | "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....The primary PK endpoints of this study were the maximum plasma concentration achieved after each dose (Cmax) as well as the extent of dexmethylphenidate absorbed into the blood expressed as the area the plasma drug concentration vs. time curve (AUC). Knowledge of these two PK parameters which define maximum and total extent of exposure are essential for a drug’s regulatory approval.

P1 data • PK/PD data • Attention Deficit Hyperactivity Disorder

Cingulate Completes Pre-NDA Meeting with FDA to Discuss New Drug Application for lead ADHD Asset CTx-1301 (GlobeNewswire) - "Cingulate Inc...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)....Our meeting with the FDA yesterday was very productive, and we remain on track for an NDA filing of CTx-1301 in mid-2025....Last month Cingulate released Phase 3 safety data for CTx-1301, as well as the results from a food effect study with healthy adults, using a single 50-mg dose of CTx-1301, Cingulate’s highest dosage....A final analysis that combines both adult and pediatric safety and efficacy data will be prepared and included in the NDA submission."

FDA event • FDA filing • Attention Deficit Hyperactivity Disorder

Cingulate Reports Safety Results from Final Phase 3 Trials for Lead ADHD Asset CTx-1301: On Track to File for FDA Approval Mid-2025 (GlobeNewswire) - P3 | N=45 | NCT05924594 | N=103 | NCT05286762 | Sponsor: Cingulate Therapeutics | "The data readout includes safety data from two Phase 3 pediatric and adolescent studies – a fixed dose study and a dose optimization study – as well as a food effect study with healthy adults, using a single 50mg dose of CTx-1301, Cingulate’s highest dosage...'in preparation for the submission of our new drug application this summer.'...The safety results of these studies have been analyzed and submitted to the FDA in preparation for an in-person Pre-NDA meeting which is scheduled for April 2, 2025...No subjects have experienced a serious treatment emergent adverse event (TEAE), a serious TEAE or a TEAE leading to death; There were no clinically relevant trends in TEAEs overall; The pharmacokinetics of the food effect study are being analyzed; however the medical findings are consistent with the previous study performed with the 25mg dose, which showed that CTx-1301 could be taken with or without food."

FDA event • FDA filing • P3 data • Attention Deficit Hyperactivity Disorder

Final Study Completed for Cingulate’s Lead Asset CTx-1301 (GlobeNewswire) - "Cingulate Inc...announced today 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)....A data readout regarding bioavailability with or without food is expected in 2Q 2025....Submission of New Drug Application Targeted for Mid 2025."

FDA filing • P1 data • Trial completion • Attention Deficit Hyperactivity Disorder

Phase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301 (clinicaltrials.gov) - P3 | N=45 | Suspended | Sponsor: Cingulate Therapeutics | N=82 ➔ 45 | Trial completion date: Apr 2024 ➔ Aug 2026 | Recruiting ➔ Suspended | Trial primary completion date: Jan 2024 ➔ Aug 2026

Enrollment change • Trial completion date • Trial primary completion date • Trial suspension • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Pediatrics • Psychiatry

Phase 3 Efficacy and Safety Fixed-Dose Study in Pediatrics (6-17) With ADHD Using CTx-1301 (clinicaltrials.gov) - P3 | N=103 | Terminated | Sponsor: Cingulate Therapeutics | Active, not recruiting ➔ Terminated; Continuation of the study is not required for NDA submission via the 505(b)(2) pathway

Trial termination • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Pediatrics • Psychiatry

Phase 3 Efficacy and Safety Fixed-Dose Study in Pediatrics (6-17) With ADHD Using CTx-1301 (clinicaltrials.gov) - P3 | N=99 | Active, not recruiting | Sponsor: Cingulate Therapeutics | Recruiting ➔ Active, not recruiting | N=385 ➔ 99

Enrollment change • Enrollment closed • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Pediatrics • Psychiatry

What’s New With Medication Treatment for ADHD? (AACAP 2023) - "The furthest along for ADHD is centanafadine, a dopamine, norepinephrine, and serotonin reuptake inhibitor. Others in clinical trials include: dexmethylphenidate ER (CTX 1301), a stimulant designed to last up to 16 hours; L-threonic acid magnesium salt, a compound that has been shown to improve ADHD symptoms in adults; and solriamfetol, a dopamine and norepinephrine reuptake inhibitor that is FDA-approved for patients with narcolepsy. Conclusions Participants will gain a better understanding of the efficacy and safety of newly approved FDA products, as well as investigational products, for the treatment of ADHD."

ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Narcolepsy • Psychiatry • Sleep Disorder

Dr. Vince Clinical Research Announces First Dosing in Cingulate Therapeutics’ CTx-1301 Phase III Laboratory Classroom Study in ADHD Patients (Businesswire) - "Dr. Vince Clinical Research...announced the first dosing in Cingulate Therapeutics’ CTx-1301 Phase III dose-optimization onset and duration laboratory classroom study. This study is taking place in pediatric patients ages 6-12 with attention-deficit/hyperactivity disorder (ADHD) and also marks the launch of DVCR’s multisite clinical trial offering to biopharmaceutical companies."

Trial status • Attention Deficit Hyperactivity Disorder • CNS Disorders

Phase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301 (clinicaltrials.gov) - P3 | N=82 | Recruiting | Sponsor: Cingulate Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Pediatrics • Psychiatry

Phase 3 Efficacy and Safety Fixed-Dose Study in Pediatrics (6-17) With ADHD Using CTx-1301 (clinicaltrials.gov) - P3 | N=385 | Recruiting | Sponsor: Cingulate Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Pediatrics • Psychiatry

Phase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301 (clinicaltrials.gov) - P3 | N=82 | Not yet recruiting | Sponsor: Cingulate Therapeutics

New P3 trial • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Pediatrics • Psychiatry

Phase 3 Efficacy and Safety Study in Adults With ADHD Using CTx-1301. (clinicaltrials.gov) - P3 | N=21 | Completed | Sponsor: Cingulate Therapeutics | Recruiting ➔ Completed

Trial completion • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Cingulate Completes Phase 3 Adult Trial of CTx-1301 (dexmethylphenidate) for ADHD (GlobeNewswire) - "Cingulate Inc...announced it has completed its Phase 3 adult dose-optimization trial of its lead candidate, CTx-1301 (dexmethylphenidate), a novel, investigational treatment being developed as a true, once-daily stimulant medication for attention deficit/hyperactivity disorder (ADHD), upon approval from the U.S. Food and Drug Administration (FDA)....Results from the trial are expected in 3Q 2023 and will be submitted for presentation at a future medical meeting....In addition to the Phase 3 adult dose-optimization study, Cingulate plans to initiate its pivotal Phase 3 fixed-dose pediatric and adolescent study and its pivotal dose-optimization onset and duration trial in pediatric patients in 3Q 2023. Assuming positive clinical results from the Phase 3 trials, Cingulate plans to submit a New Drug Application (NDA) for CTx-1301 in mid-2024 under the Section 505(b)(2) pathway."

Trial status • Attention Deficit Hyperactivity Disorder • CNS Disorders

Phase 3 Efficacy and Safety Study in Adults With ADHD Using CTx-1301. (clinicaltrials.gov) - P3 | N=25 | Recruiting | Sponsor: Cingulate Therapeutics | Trial completion date: Mar 2023 ➔ Sep 2023 | Trial primary completion date: Mar 2023 ➔ Jun 2023

Trial completion date • Trial primary completion date • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry