• 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
    • JobWatch
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Pipeline

Pipeline

April 5, 2021
Company Drug/Device Medical Condition Status
COVID-19 Trials and Actions
University of California

Centers for Integrative Medicine & Health
agarikon and turkey tail mushroom varieties patients with early-stage COVID-19 initiation of clinical trial
Gritstone Oncology COVID-19 vaccine COVID-19 first patients dosed in phase 1 trial
Foresee Pharmaceuticals FP-025 adult patients with severe-to-critical COVID-19 with associated acute respiratory distress syndrome first patients dosed in phase 2/3 trial
Becton Dickenson BD Veritor Plus System rapid antigen test detection of SARS-CoV-2, influenza A and influenza B Emergency Use Authorization (EUA) granted by the FDA
Escher Biomedical Diagnostics Escher BT-MED COV19 Saliva Test detection of SARS-CoV-2 virus EUA granted by the FDA
Other Trials and Actions
Everest Medicines Trodelvy (sacituzumab govitecan-hziy) cancers with high TROP-2 expression trial authorized by the China National Medical Products Administration
Stoke Therapeutics STK-001 Dravet syndrome trial authorized by the UK Medicines and Healthcare products Regulatory Agency
Curevo Vaccine CRV-101, varicella (chickenpox) vaccine vaccine for immunocompromised pediatrics infected with HIV trial authorized by the South African Health Products Regulatory Authority
Airway Therapeutics AT-100 (rhSP-D) bronchopulmonary dysplasia IND approved by the FDA
Antibe Therapeutics otenaproxesul osteoarthritis pain IND approved by the FDA
Enterome EO2463 indolent nonHodgkin B-cell lymphomas IND approved by the FDA
I-Mab

ABL Bio
TJ-CD4B/ABL111 advanced or metastatic solid tumors IND approved by the FDA
Attgeno Supernitro patients with life-threatening conditions associated with acute lung injury first patients dosed in phase 1 trial
Aptorum Group ALS-4 infections caused by staphylococcus aureus, including MRSA first patient dosed in phase 1 trial
D&D Pharmatech DD01 obese patients with diabetes and nonalcoholic fatty liver disease first patient dosed in phase 1 trial
Hutchison Meditech HMPL-306 advanced solid tumors initiation of phase 1 trial
Hutchison Meditech HMPL-306 hematological malignancies initiation of phase 1 trial
Theratechnologies TH1902 sortilin-positive (SORT1+) solid tumors first patient dosed in phase 1 trial
CohBar CB4211 nonalcoholic steatohepatitis and obesity patient enrollment complete in phase 1b trial
Dermata Therapeutics DMT310 mild-to-moderate psoriasis first patient dosed in phase 1b trial
Flexion Therapeutics FX301 postoperative pain following bunionectomy first patient dosed in phase 1b trial
Daiichi Sankyo

AstraZeneca
Enhertu (trastuzumab deruxtecan) patients with HER2 mutated metastatic nonsmall-cell lung cancer with disease recurrence or progression during or after at least one prior platinum-containing treatment regimen first patient dosed in phase 2 trial
Intensity Therapeutics

Portage Biotech
INT230-6 (PORT-1) early-stage breast cancer initiation of phase 2 trial
Istari Oncology PVSRIPO alone or in combination with a programmed death receptor-1/ligand 1 (PD-1/L1) inhibitor melanoma resistant to these checkpoint therapies first patient dosed in phase 2 trial
Milestone Therapeutics etripamil nasal spray atrial fibrillation and rapid ventricular rate first patient enrolled in phase 2 trial
NeoImmuneTech NT-I7 (efineptakin alfa) newly diagnosed, nonsevere lymphopenic high-grade glioma following standard radiation therapy and temozolomide first patient dosed in phase 2 trial
ORYZON Genomics vafidemstat borderline personality disorder first patient enrolled in phase 2b trial
Biohaven Pharmaceuticals oral zavegepant preventive treatment of migraine first patient enrolled in phase 2/3 trial
Exelixis cabozantinib (Cabometyx), nivolumab (Opdivo) and ipilimumab (Yervoy) previously untreated advanced intermediate- or poor-risk renal cell carcinoma patient enrollment complete in phase 3 trial
Pharnext PXT3003 Charcot-Marie tooth disease type 1A first patient enrolled in phase 3 trial
Fractyl Laboratories Revita DMR (duodenal mucosal resurfacing) device type 2 diabetes initiation of pivotal trial
Moleculin Biotech Annamycin soft tissue sarcoma lung metastases Fast Track designation granted by the FDA
Syndax Pharmaceuticals axatilimab chronic graft vs. host disease Orphan Drug designation granted by the FDA
Premia Spine TOPS facet arthroplasty system joint replacement system for the lumbar spine Breakthrough Device designation granted by the FDA
Astellas Myrbetriq (mirabegron extended-release tablets) and Myrbetriq Granules (mirabegron for extended-release oral suspension) neurogenic detrusor overactivity in children age three and older approved by the FDA for expanded indication
Celgene/Bristol-Myers Squibb Abecma (idecabtagene vicleucel) adult multiple myeloma that has not responded to or has returned after at least four prior lines of therapy approved by the FDA
Jazz Pharmaceuticals Vyxeos (daunorubicin and cytarabine) newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in pediatric patients age one and older approved by the FDA for expanded indication
Guardant Health Guardant360 CDx test liquid biopsy for comprehensive tumor mutation profiling across all solid cancers approved by the FDA
Medtronic Harmony Transcatheter Pulmonary Valve congenital heart disease approved by the FDA
Amarin Vazkepa (icosapent ethyl) risk of cardiovascular events in high-risk, statin-treated adult patients who have elevated triglycerides (?150 mg/dL) and either established cardiovascular disease or diabetes and at least one additional cardiovascular risk factor approved by the European Commission
Ipsen

Bristol Myers Squibb
Cabometyx (cabozantinib) plus Opdivo (nivolumab) first-line treatment of advanced renal cell carcinoma approved by the European Commission
PTC Therapeutics Evrysdi (risdiplam) spinal muscular atrophy in patients age two months and older approved by the European Commission

 

Upcoming Events

  • 17May

    Three Data Trends to Consider Now When Developing Your Decentralized Clinical Trial Strategy

  • 24May

    Powering an Effective Oversight Strategy with Clinical and Operational Insights

  • 25May

    2022 WCG Avoca Quality & Innovation Summit: Own the Future

  • 28Jun

    Effective Root Cause Analysis and CAPA Investigations for the Life Sciences

  • 16Oct

    WCG MAGI's Clinical Research Hybrid Conference - 2022 West

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

  • Protocol-360x240.png

    Avoid Deviations by Making Protocol Review a Team Effort

  • SelectionProcess-360x240.png

    Give Us a Voice: Sites Clamor for a Say on Vendor Selection

  • Convince-360x240.png

    Use Data and Details to Convince Site Leadership to Add Staff

  • AsktheExpertsBadge-360x240.png

    Ask the Experts: Listing Trial Staff and Others on the Statement of Investigator

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 © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing