NDA Filing for Advanced ADHD Treatment, CTx-1301 underpinned by BDD’s OralogiK™ Platform.

Glasgow, UK – August 06, 2025

BDD Pharma Ltd., a leading drug delivery and clinical research company, today congratulated its partner and friends at Cingulate Inc. on reaching a major regulatory milestone with the submission of a New Drug Application (NDA) to the FDA for CTx-1301, an industry-changing once-daily treatment for Attention Deficit/Hyperactivity Disorder (ADHD).
CTx-1301, which leverages BDD’s proprietary OralogiK™ controlled-release technology, provides single dose full symptom control throughout the day – a significant improvement on current treatments which are known to wear off in the late afternoon necessitating the need for an additional “booster” dose.

The novel triple-pulse formulation overcomes this issue by delivering three precisely timed drug releases from a single tablet throughout the day. The final release is scheduled at the point when a standard extended-release medication would typically lose efficacy. This triple-pulse approach eliminates the need for late-day booster doses and offers continuous coverage throughout the active day, improving patient convenience and daily functioning.

BDD’s team hailed the NDA filing as a triumph for Cingulate and a validation of the OralogiK™ platform, calling the product a potential “game changer” for ADHD patients by providing all-day symptom control from a single morning dose.

BDD has collaborated closely with the Cingulate team throughout the development of CTx1301, conducting the early formulation work and clinical testing activities – including a specialised Phase 1 scintigraphic study conducted at BDD’s Glasgow site which confirmed the in vivo performance of the OralogiK™ enabled tablet. “The proof‑of‑concept study clearly demonstrated that the OralogiK™ platform delivers each release exactly as designed,” commented Dr Carol Thomson, Chief Executive Officer of BDD Pharma. This validation laid the foundation for Cingulate’s later Phase II/III trials, which have shown meaningful improvements in ADHD symptom control and a consistent safety profile in both adult and paediatric populations, culminating in the NDA filing.

“We are absolutely delighted to see our OralogiK™ technology at the heart of Cingulate’s groundbreaking ADHD therapy as it reaches this important regulatory milestone,” said Calum Stevens, Commercial Director at BDD. “CTx-1301 is the next generation in ADHD treatment – delivering truly all-day relief in a single tablet to improve patients’ lives. We congratulate the entire Cingulate team on their achievement and look forward to CTx-1301’s continued success through the FDA review process and beyond.”

About BDD Pharma Ltd.
BDD Pharma Ltd. is a UK-based contract research and development organization (CRO/CDMO) specializing in oral drug delivery, formulation development, GMP manufacturing, and early-phase clinical trials. With over 25 years of experience, BDD provides integrated services to efficiently advance new therapies from concept to First-in-Human studies, leveraging proprietary technologies like OralogiK™ to optimise drug delivery and therapeutic outcomes. BDD’s capabilities – including in-house gamma scintigraphy imaging and an on-site MHRA-accredited clinical unit – enable rapid iteration and proof-of-concept for novel drug products. For more information, visit www.bddpharma.com.

About Cingulate Inc.
Cingulate Inc. (NASDAQ: CING) is a biopharmaceutical company utilizing its proprietary PTR drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, designed to improve the lives of patients suffering from frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment outcomes. With an initial focus on the treatment of ADHD, Cingulate is identifying and evaluating additional therapeutic areas where PTR technology may be employed to develop future product candidates, including to treat anxiety disorders. Cingulate is headquartered in Kansas City. For more information, visit Cingulate.com.

About CTx-1301
Cingulate’s lead candidate, CTx-1301, utilizes Cingulate’s proprietary PTR drug delivery platform to create a breakthrough, multi-core formulation of the active pharmaceutical ingredient dexmethylphenidate, a compound approved by the FDA for the treatment of ADHD. Dexmethylphenidate is part of the stimulant class of medicines and increases norepinephrine and dopamine activity in the brain to affect attention and behavior. While stimulants are the gold standard of ADHD treatment due to their efficacy and safety, the long-standing challenge continues to be providing patients with an entire active-day duration of action. CTx-1301 is designed to precisely deliver three releases of medication at the predefined time, ratio, and style of release to optimize patient care in one tablet. The result is a rapid onset and entire active-day efficacy, with the third dose being released around the time when other extended-release stimulant products begin to wear off.

For more information, please visit: www.bddpharma.com

ENDS
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BDD Pharma Ltd.
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