Cingulate Therapeutics

What Cingulate Therapeutics does

Cingulate Therapeutics is a clinical-stage biopharmaceutical company developing once-daily central nervous system therapeutics for Attention Deficit/Hyperactivity Disorder (ADHD) and anxiety disorders using its proprietary Precision Timed Release (PTR) drug delivery platform. The company's lead candidate, CTx-1301 (dexmethylphenidate HCl), is designed as a true once-daily trimodal tablet delivering 35% of the daily dose as an immediate release within 5–6 minutes, 45% as a delayed sustained release three hours after administration, and 20% as a second delayed release seven hours after administration, targeting rapid onset and full active-day efficacy without booster doses. The PTR platform is built around a proprietary Erosion Barrier Layer (EBL) tablet-in-tablet architecture licensed from BDD Pharma (OralogiK formulation), combined with specialized compression technology.

Cingulate's broader pipeline includes CTx-1302 (dextroamphetamine) for ADHD and CTx-2103 (buspirone) for generalized anxiety disorder, both leveraging the same PTR platform. CTx-1301 completed Phase 3 trials with statistically significant efficacy (p < 0.001), and the company submitted its NDA on July 31, 2025 under the 505(b)(2) pathway; the FDA accepted the filing in October 2025 with a PDUFA target action date of May 31, 2026, and ultimately issued a Complete Response Letter on June 2, 2026 requesting additional Chemistry, Manufacturing and Controls information without raising clinical safety or efficacy concerns. The company was issued its first company-owned U.S. patent (No. 12,653,791) in June 2026 with exclusivity through December 2042, alongside a granted European patent validating in 30+ territories.

Cingulate is pre-commercial and currently generates no product revenue, with a $22.4 million net loss in FY2025 and a $141.7 million accumulated deficit as of March 31, 2026. Its planned go-to-market model combines a contracted U.S. manufacturing partnership with Bend Bio Sciences (exclusive through 2028), an AI-driven digital commercialization partnership with Indegene (announced November 2025), and contract sales force deployment via IQVIA upon FDA approval — a variable-cost architecture designed to scale with launch milestones rather than fixed overhead. The company went public on NASDAQ at $6 per share on December 7, 2021 under ticker CING, is headquartered in Kansas City, KS, and trades as a clinical-stage public company with cash and equivalents of $25.9M as of Q1 2026.

Name

Cingulate Therapeutics

Legal name

Cingulate Therapeutics, Inc.

Website

https://cingulate.com

Company type

Public

Founded year

2017

Operating status

Operating

Headcount range

11–50 employees

Short description

Cingulate Therapeutics is a clinical-stage biopharmaceutical company developing once-daily ADHD and anxiety therapeutics using its proprietary Precision Timed Release (PTR) tablet-in-tablet drug delivery platform. Pre-commercial; lead candidate CTx-1301 received an FDA Complete Response Letter in June 2026 requesting CMC items only.

Ownership category

akta.pro rank

Product category

ADHD Therapeutics / Central Nervous System Pharmaceuticals

NAICS

Pharmaceutical and Medicine Manufacturing (32541)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Neurology & CNS Specialty Pharmaceuticals (HLAIACAC)

Keywords

• Central nervous system therapeutics
• ADHD pharmaceutical products
• Precision timed release tablets
• Extended release dexmethylphenidate
• Once-daily stimulant medications

Headquarters

HQ city

Mission

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2C

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Supply Chain, Marketing or Sales, Operations

Revenue model

1. Pharmaceutical Product Sales: Revenue will be generated from sales of prescription pharmaceutical products, specifically CTx-1301 (dexmethylphenidate) for ADHD and future pipeline products including CTx-1302 for ADHD and CTx-2103 for anxiety disorders. The company is pre-commercial and has not yet generated revenue from product sales.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Cingulate Therapeutics is a clinical-stage biopharmaceutical company developing once-daily, multi-dose pharmaceutical tablets for ADHD and anxiety disorders using its proprietary Precision Timed Release (PTR) drug delivery platform. Its lead product candidate CTx-1301 (dexmethylphenidate HCl) is an investigational ADHD medication designed to deliver three precisely timed releases from a single daily tablet, eliminating the need for booster doses. Pipeline candidates include CTx-1302 (dextroamphetamine) for ADHD and CTx-2103 (buspirone) for anxiety disorders.

Product overview

Cingulate Therapeutics is a clinical-stage biopharmaceutical company developing a pipeline of next-generation pharmaceutical products utilizing its proprietary Precision Timed Release (PTR) drug delivery platform technology. The company's portfolio includes three product candidates: CTx-1301 (dexmethylphenidate) and CTx-1302 (dextroamphetamine) for ADHD treatment, and CTx-2103 (buspirone) for anxiety disorders. The PTR platform enables once-daily multi-dose delivery through tablet-in-tablet technology with precisely timed drug releases, addressing the unmet need for true once-daily dosing in CNS disorders.

Differentiator

Problem solved

Functional benefit

Brands

• Precision Timed Release (PTR): Proprietary drug delivery platform technology enabling multi-dose tablet formulations for precise drug release timing
• CTx-1301
• CTx-1302
• CTx-2103

Products and services

• CTx-1301 (dexmethylphenidate HCl) A once-daily, multi-core tablet for ADHD treatment utilizing the Precision Timed Release (PTR) platform to deliver three precisely timed releases of dexmethylphenidate across the day, providing rapid onset and entire active-day efficacy for patients with ADHD.
• CTx-1302 (dextroamphetamine) A once-daily, multi-core tablet for ADHD treatment utilizing the Precision Timed Release (PTR) platform, designed to deliver three precisely timed releases of dextroamphetamine for entire active-day symptom control in patients with ADHD.
• CTx-2103 (buspirone) A once-daily, multi-core tablet for anxiety treatment utilizing the Precision Timed Release (PTR) platform, designed to deliver three precisely timed releases of buspirone to replace multiple daily doses of standard anxiety treatment.
• Precision Timed Release (PTR) Platform Technology Cingulate's proprietary drug delivery platform technology that incorporates a proprietary Erosion Barrier Layer (EBL) to provide control of drug release at precise, pre-defined times, enabling tablet-in-tablet dose forms for multi-dose delivery from a single daily tablet. The EBL formulation technology (OralogiK) is licensed from BDD Pharma.

Quantifiable outcome

• Statistically significant efficacy demonstrated in Phase 3 trials (p < 0.001)
• +3 more outcomes

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Seven partnerships are on record, tiered core and supporting.

• IndegenecoreStrategic or Co-development Partner · 10 November 2025Digital-first life sciences commercialization company partnered to prepare for potential CTx-1301 launch. Indegene provides AI-driven, data-rich platform designed to optimize prescriber reach, payer access, and patient support with a variable-cost structure aligning commercial execution with growth milestones.
• Bend Bio SciencescoreImplementation/ SI/ Consulting Partner · 17 September 2025Exclusive commercial manufacturing partner for CTx-1301 in the United States through 2028 if approved by FDA. Bend Bio Sciences serves as the sole U.S. manufacturer, with Cingulate committed to purchasing 100% of its overall U.S. commercial supply.
• BDD PharmacoreTechnology or IntegrationLicensing partner for OralogiK Erosion Barrier Layer (EBL) formulation technology used in Cingulate's Precision Timed Release platform. BDD Pharma specializes in double/triple pulse and complex release tablet formulations.
• Dr. Vince Clinical Research (DVCR)supportingImplementation/ SI/ Consulting PartnerFull-service CRO with clinical pharmacology unit and GMP compliant pharmacy. Specializes in early phase trials for both healthy volunteers and patient populations.
• Global Pharmaceutical PartnerssupportingStrategic or Co-development PartnerPartner with proficiency in attracting development partners and international licensing deals. Expertise spans specialty pharma, generic, innovative and hybrid companies.
• Premier ResearchsupportingImplementation/ SI/ Consulting PartnerClinical research organization with experienced professionals capable of managing complex clinical studies from Phase 1 to Phase 4 with therapeutically focused teams.
• IQVIA Inc.supportingChannel Partner/ Reseller/ DistributorAgreement with IQVIA for deployment of sales team upon potential FDA approval of CTx-1301. IQVIA provides commercial field force services.

Scale indicators11 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Supernus Pharmaceuticals: Specialty CNS pharmaceutical company with marketed ADHD products (Qelbree) and a pipeline of CNS candidates using novel delivery technologies. Closest comparable by therapeutic focus (ADHD/CNS), specialty commercial model, and stage of commercial evolution.
• KemPharm: Specialty pharma focused on CNS with Azstarys (serdexmethylphenidate/dexmethylphenidate) - a competing ADHD product. Highly comparable as it pairs a prodrug/extended-release technology with the same active pharmaceutical ingredients Cingulate is reformulating.
• Tris Pharma: Specialty CNS pharma with multiple ADHD products including Dyanavel XR and Quillivant XR using novel extended-release delivery. Comparable through its proprietary release technology platform and ADHD franchise focus.
• Collegium Pharmaceutical: Specialty CNS pharma that acquired Ironshore Pharmaceuticals (the company where CLO Nilay Patel previously worked) for $550M. Directly comparable by specialty CNS positioning and ADHD product (Jornay PM) built around a novel timed-release formulation.
• Neos Therapeutics: Specialty pharma historically focused on ADHD with extended-release products (Adzenys XR-ODT, Cotempla XR-ODT). Comparable through ADHD specialty franchise and novel oral delivery technologies, though smaller and earlier-stage.
• Ironshore Pharmaceuticals (acquired by Collegium): Pre-acquisition, Ironshore developed Jornay PM (methylphenidate) - a once-daily ADHD product with delayed-release profile. Direct comparable by product concept (timed, once-daily stimulant delivery) and the CLO of Cingulate led the legal/compliance functions through the $550M acquisition.

Broad incumbents

• Pfizer: Markets Focalin XR (dexmethylphenidate), the reference product for Cingulate's 505(b)(2) NDA pathway. CEO Schaffer previously led ADHD franchise at Pfizer. Large incumbent with established ADHD share, deep payer relationships, and significant commercial scale.
• Takeda Pharmaceutical: Markets Vyvanse (lisdexamfetamine), one of the leading branded ADHD products. Broad incumbent presence in the same therapeutic area with significantly larger commercial infrastructure and global footprint.
• Teva Pharmaceutical: Markets generic Adderall XR and other CNS products. Broad incumbent setting pricing/reimbursement baselines for ADHD stimulants that any Cingulate launch must compete against.
• Corium (now part of Lotus Pharmaceutical/Lotte): CNS specialty pharma with ADHD product (Adzenys XR-ODT) developed using novel oral delivery technology. Comparable through specialty CNS franchise and reformulation-focused approach to stimulant therapy.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks7 records

Key highlights6 records

Customer concentration

• Xx.com/CingulateInc
• YouTubeyoutube.com/@Cingulate-sl2ic
• Facebookfacebook.com/CTxADHD
• LinkedInlinkedin.com/company/cingulate-therapeutics

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Funding overview

Funding rounds14 records

Investors3 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Cingulate Therapeutics