We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » ACOLOGIX REPORTS AC-100 DATA

ACOLOGIX REPORTS AC-100 DATA

June 30, 2006

Acologix has reported Phase II clinical study data of AC-100, its novel synthetic peptide derived from an endogenous human protein produced by bone and dental cells. The data demonstrated that AC-100 stimulated the formation of new dentin (the hard tissue of teeth that protects the tooth pulp and supports the outer enamel) when applied to tooth defects.

The randomized, double-blind, placebo-controlled trial enrolled 35 patients who were candidates for at least two third-molar (wisdom teeth) extractions. Patients served as their own controls, with one molar treated with 200 ug AC-100 (applied on Days 0, 2 and 4 through the dentin tubules) and the other with a placebo. After two months, the teeth were extracted and evaluated for remaining dentin thickness (RDT), new dentin formation, inflammation and necrosis. Administration of AC-100 resulted in a clear trend in the formation of new dentin compared to placebo.

KEYWORDS Drug Pipeline Alert

Upcoming Events

  • 09Feb

    The Inextricable Link Between Data Integrity and Quality Culture

  • 15Feb

    Advanced Compliance Writing CAPA: Mastering Failure Investigation and Root Cause Analysis

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

  • 22Feb

    Best Practices for Developing and Maintaining a GxP Training Matrix

  • 07Mar

    FDA’s Remote Assessments v. Remote Interactive Evaluations: Do You Really Know the Difference?

  • 08Mar

    Medical Device Cybersecurity: The Regulatory Landscape and How to Defend Your Practices During an Inspection

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • Boston Scientific’s Single Use Ureteroscope Gets FDA Clearance

  • Gilead’s Trodelvy Gets Expanded Approval in Breast Cancer

  • AI Software to Improve Echocardiogram Images Gets FDA Clearance

  • Rocket Pharmaceuticals Gets RMAT Designation for Danon Disease Gene Therapy

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell or Share My Data
Footer Logo

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

Phone 703.538.7600 – Toll free 888.838.5578

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