• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • Patient Education
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Pipeline

Pipeline

April 30, 2018
Company Drug/Device Medical Condition Status
AOBiome Therapeutics Ammonia Oxidizing Bacteria (AOB) intranasal spray episodic migraine Phase II trial initiated enrolling 303 subjects
Mithra Donesta Vasomotor Symptoms (VMS) in post-menopausal women Phase II top-line results announced evaluating 257 subjects
Concert Pharmaceuticals CTP-543 moderate-to-severe alopecia areata Phase IIa trial initiated evaluating 90 subjects
Aldeyra Therapeutics, Inc. topical ocular reproxalap allergic conjunctivitis Phase III trial initiated enrolling 300 subjects
Catalyst Pharmaceuticals, Inc. Firdapse (amifampridine phosphate) MuSK antibody positive Myasthenia Gravis (MuSK-MG) Phase III trial initiated enrolling 60 subjects in the U.S. and Italy
Pfizer Inc. TRUMENBA (Meningococcal Group B Vaccine) Active immunization to prevent invasive disease caused by Neisseria meningitides group B (MenB) in children ages 1 through 9 years Breakthrough Therapy Designation granted by the FDA
Lumendi, LLC DiLumen C2 second-generation endoscopic accessory indicated to ensure complete positioning of an endoscope in the large intestine and assist with optical visualization, diagnosis and endoscopic treatment 510(k) clearance granted by the FDA
Varian Calypso Anchored Beacon transponder tumor detection 510(k) clearance granted by the FDA
Amerigen Pharmaceuticals Limited and Dipharma S.A. Miglustat 100 mg capsules Adult patients with mild to moderate type 1 Gaucher disease for whom enzyme replacement therapy is not a therapeutic option aNDA filed with the FDA
Sage Therapeutics intravenous formulation of brexanolone (SAGE-547) postpartum depression (PPD) NDA filed with the FDA
Veloxis Pharmaceuticals A/S de novo indication of ENVARSUS XR (tacrolimus extended-release tablets) Prophylaxis of organ rejection in kidney transplant patients sNDA filed with the FDA
Abeona Therapeutics Inc. ABO-102 AAV-mediated gene therapy for the treatment of Sanfilippo syndrome Type A (MPS IIIA) RMAT Designation granted by the FDA
MeiraGTx Limited AAV-RPGR X-linked retinitis pigmentosa (SLRP) due to defects in the retinitis pigmentosa GTPase regulator (RPGR) gene Fast Track Designation granted by the FDA
Polyphor balixafortide (POL6326) in combination with eribulin patients with HER2-negative metastatic breast cancer who previously received at least two chemotherapeutic regiments in the metastatic setting Fast Track Designation granted by the FDA
QIAGEN PartoSure preterm birth FDA approved

Upcoming Events

  • 26Jan

    Reducing Complexity in Starting Clinical Trials – More Patients, Faster Startup

  • 27Jan

    Medical Device Clinical Trials in China: Latest Regulatory Developments

  • 11Feb

    Lab X.0: Addressing Quality and Compliance Challenges in Laboratory Operations in the COVID-19 All-Digital Era

  • 23Mar

    Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

  • 26Apr

    MAGI's Clinical Research vConference — Spring 2021

Featured Products

  • Regenerative Medicine – Steps to Accelerate Development : PDF

    Regenerative Medicine: Steps to Accelerate Development

  • Clinical Trial Agreements — A Guide to Key Words and Phrases : PDF

    Clinical Trial Agreements: A Guide to Key Words and Phrases

Featured Stories

  • TechInnovation-360x240.png

    Pace of Technology Innovation in Trials Could Slow After Pandemic Eases

  • AskTheExperts-360x240.png

    Ask the Experts: Certifying and Maintaining Copies of Original Source Documents

  • Resources-360x240.png

    Trial Complexity, Endpoints Continue to Increase, Stretching Site Resources

  • FocusinRed-360x240.png

    Return to Focus on Risk Management Postpandemic Could Prove Challenging to Sites

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 My Personal Information

Footer Logo

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

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing