• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trial Listings
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Clinical Trial Listings
  • Advertise
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Catalent, Cingulate Therapeutics ink agreement for new ADHD treatments

Catalent, Cingulate Therapeutics ink agreement for new ADHD treatments

September 30, 2014
CenterWatch Staff

Catalent Pharma Solutions, headquartered in Somerset, N.J., has reached an exclusive development and licensing agreement with Cingulate Therapeutics (CTx), a Morristown, N.J.-based, privately held biopharmaceutical company, to support development of a series of new prescription pharmaceutical products for the treatment of attention deficit/hyperactivity disorder (ADHD) using Catalent's OSDrC OptiDose drug delivery platform.

The products, CTX-1301 and CTX-1302, currently are in preclinical development and are designed to overcome several long-standing unmet needs of patients diagnosed with ADHD. The company's lead product, CTX-1301, is expected to complete initial phase I/phase II human trials in early 2015. Cingulate Therapeutics primary focus is to develop and commercialize the CTx products in the U.S. subsequent to FDA review and approval, followed by the E.U. and other strategically important markets.

Catalent's OSDrC OptiDose is an innovative, flexible core tableting technology that enables the formulation and manufacturing of single or multi-cored tablets with differentiated controlled-release functionality and a range of unique dose forms, including fixed-dose combination tablets.

"OptiDose enables the design of dividable, multi-layer, single or multi-core tablets with a variety of core numbers, shapes, sizes and placement, providing new alternatives in controlled-release designs for drug formulators, developers and marketers in a high-quality, one-step manufacturing process," said Barry Littlejohns, president of Advanced Delivery Technologies for Catalent. 

Upcoming Events

  • 12Apr

    The Participant Playbook Webinar Series, Part 3 — Rethinking the Development of Participant-Centric Clinical Trial Technology

  • 25Apr

    Effective Root Cause Analysis and CAPA Investigations for Drugs, Devices and Clinical Trials

  • 26Apr

    FDA’s New Laws and Regulations: What Drug and Biologics Manufacturers Need to Know

  • 27Apr

    Califf’s FDA, 2023 and Beyond: Key Developments, Insights and Analysis

  • 17May

    2023 WCG Avoca Quality Consortium Summit

  • 21May

    WCG MAGI Clinical Research Conference – 2023 East

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • Five Ws

    Consider the Five ‘W’s to Understand Potential Participants

  • QandA-360x240.png

    Perspectives from Smaller-Sized CROs: Q&A with Cheryle Evans

  • White House

    Trial Stakeholders Advise White House on Emergency Research Infrastructure

  • SurveywBlueBackground-360x240.png

    Stress Levels Continue to Climb in Healthcare Workforce, Survey Finds

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell or Share My Data

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing