• 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
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Drug & Device Pipeline News

Drug & Device Pipeline News

December 12, 2022
Company Drug/Device Medical Condition Status
Trials Authorized
Beam Therapeutics BEAM-201 Relapsed/refractory T-cell acute lymphoblastic leukemia/T-cell lymphoblastic lymphoma IND approved by the FDA for a phase 1 trial
AltruBio ALTB-268 Ulcerative colitis IND approved by the FDA for a phase 1 trial
Pyxis Oncology PYX-201 Solid tumors IND approved by the FDA for a phase 1 trial
Pyxis Oncology PYX-106 Solid tumors IND approved by the FDA for a phase 1 trial
BioCardia Allogeneic NK1R+ human mesenchymal stem cells Ischemic heart failure IND approved by the FDA for a phase 1/2 trial
Opus Genetics OPGx-001 Leber congenital amaurosis resulting from biallelic mutations in the LCA5 gene IND approved by the FDA for a phase 1/2 trial
IN8bio INB-400 Newly diagnosed glioblastoma IND approved by the FDA for a phase 2 trial
Hexaell Biotechnology HepaCure Biocolumn bioartificial liver Acute-on-chronic liver failure syndromes IND approved by China’s regulatory authorities for a phase 1/2 trial
Trials Initiated
Cytokinetics CK-3828136 Heart failure with reduced ejection fraction and other types of heart failure Initiation of phase 1 trial
Federation Bio FB-001 Enteric hyperoxaluria Initiation of phase 1 trial
Horizon Therapeutics HZN-457 Gout Initiation of phase 1 trial
Sionna Therapeutics SION-638 Cystic fibrosis Initiation of phase 1 trial
Innovent Biologics

Union Therapeutics
Orismilast Inflammatory disorders including psoriasis and atopic dermatitis Initiation of phase 1 trial in China
Arcutus Biotherapeutics ARQ-255 Alopecia areata Initiation of phase 1b trial
Bio-Path Holdings BP1001-A Solid tumors, including ovarian, endometrial, pancreatic and breast cancer Initiation of phase 1/1b trial
iOnctura SA IOA-289 Metastatic pancreatic cancer Initiation of phase 1b trial
Dragonfly Therapeutics DF9001 Locally advanced or metastatic solid tumors Initiation of phase 1/2 trial
Qurient Q901 Advanced solid tumors Initiation of phase 1/2 trial
Baudax Bio BX1000 Neuromuscular blockade in patients undergoing elective surgery Initiation of phase 2 trial
Dragonfly Therapeutics DF1001 Advanced solid tumors Initiation of phase 2 trial
Lynk Pharmaceuticals LNK01003 Active ulcerative colitis Initiation of phase 2 trial
Ventyx Biosciences VTX958 Moderate-to-severe plaque psoriasis Initiation of phase 2 trial
Otsuka Pharmaceuticals

Sunovion Pharmaceuticals
Ulotaront Major depressive disorder Initiation of phase 2/3 trial
Celcuity Gedatolisib HR+/HER2- advanced breast cancer Initiation of phase 3 trial
Approvals
Rigel Pharmaceuticals Rezlidhia (olutasidenib) Relapsed/refractory acute myeloid leukemia with susceptible IDH1 mutation Approved by the FDA
SCYNEXIS Brexafemme (ibrexafungerp tablets) Reduction in the incidence of recurrent vulvovaginal candidiasis Approved by the FDA for additional indication
Endomag Magtrace lymphatic tracer Breast cancer surgery Approved by the FDA
Acutus Medical AcQMap 3D Imaging and Mapping Catheter Ultrasound imaging Approved in the European Union
PTC Therapeutics Waylivra (volanesorsen) Familial partial lipodystrophy Approved in Brazil

 

To view more CenterWatch Weekly stories, click here.

Upcoming Events

  • 16Feb

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

  • 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

  • SurveywBlueBackground-360x240.png

    Sites Name Tech Acceptance as Essential Factor in Selection of Sponsors, Survey Finds

  • TrendsInsights2023-360x240.png

    WCG Clinical Research Trends and Insights for 2023, Part Two

  • TimeMoneyEffort-360x240.png

    Time is Money and So Is Effort, Budgeting Experts Say

  • TrendsInsights2023A-360x240.png

    WCG Clinical Research Trends and Insights for 2023, Part Three

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