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

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

Cingulate Announces Successful Transfer of CTx-1301 (dexmethylphenidate) Proprietary PTR Manufacturing Processes to Societal CDMO (GlobeNewswire) - "Cingulate Inc...announced the successful completion of the manufacturing transfer of its lead candidate, CTx-1301 (dexmethylphenidate), to Societal CDMO, Inc...a bi-coastal contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development....Cingulate has completed the first cohort of its Phase 3 adult onset and duration trial and has now initiated the second cohort, with results expected in the third quarter of 2023. In addition to the Phase 3 adult dose-optimization study, the Company plans to commence its pivotal Phase 3 fixed-dose pediatric and adolescent study in mid-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."

Licensing / partnership • NDA • P3 data • Trial status • Attention Deficit Hyperactivity Disorder • CNS Disorders

"$CINGW $CING Cingulate Announces Successful Transfer of CTx-1301 (dexmethylphenidate) Proprietary PTR™ Manufacturing Processes to Societal CDMO https://t.co/WVDjfTgp8y" (@stock_titan)

Phase 3 Efficacy and Safety Study in Adults With ADHD Using CTx-1301. (clinicaltrials.gov) - P3 | N=25 | Recruiting | Sponsor: Cingulate Therapeutics | Not yet recruiting ➔ Recruiting

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

Cingulate Initiates Phase 3 Study of Lead Asset CTx-1301, Designed as a True Entire Active-Day Treatment for ADHD (GlobeNewswire) - "Cingulate Inc....announced the initiation of the first Phase 3 clinical trial of its lead candidate CTx-1301, a novel, investigational, trimodal, extended release tablet formulation of dexmethylphenidate, a compound approved by the U.S. Food and Drug Administration (FDA) for the treatment of attention deficit/hyperactivity disorder (ADHD)....The trial is expected to take three months to complete and initial results are expected in the first half of 2023."

New P3 trial • P3 data • Attention Deficit Hyperactivity Disorder • CNS Disorders

Phase 3 Efficacy and Safety Study in Adults With ADHD Using CTx-1301. (clinicaltrials.gov) - P3 | N=25 | Not yet recruiting | Sponsor: Cingulate Therapeutics

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

Phase 3 Efficacy and Safety in Pediatrics (6-17) With Attention-Deficit/Hyperactivity Disorder Using CTx-1301 (clinicaltrials.gov) - P3 | N=312 | Not yet recruiting | Sponsor: Cingulate Therapeutics | Trial completion date: Jun 2023 ➔ Dec 2023 | Initiation date: Dec 2022 ➔ Jun 2023 | Trial primary completion date: Jun 2023 ➔ Dec 2023

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

Fed-Fast Crossover Study to Assess the Effect of Food With CTx-1301 in Healthy Subjects (clinicaltrials.gov) - P1 | N=27 | Completed | Sponsor: Cingulate Therapeutics | Not yet recruiting ➔ Completed

Trial completion

A Phase 3 Efficacy and Safety in Pediatrics (6-17) With Attention-Deficit/Hyperactivity Disorder (ADHD) Using CTx-1301 (Dexmethylphenidate) (clinicaltrials.gov) - P3 | N=312 | Not yet recruiting | Sponsor: Cingulate Therapeutics | Trial completion date: Dec 2022 ➔ Jun 2023 | Initiation date: Jul 2022 ➔ Dec 2022 | Trial primary completion date: Dec 2022 ➔ Jun 2023

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

A Phase 3 Efficacy and Safety in Pediatrics (6-17) With Attention-Deficit/Hyperactivity Disorder (ADHD) Using CTx-1301 (Dexmethylphenidate) (clinicaltrials.gov) - P3 | N=312 | Not yet recruiting | Sponsor: Cingulate Therapeutics | Initiation date: Apr 2022 ➔ Jul 2022

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