Prescribe Right
Prescribe Right
  • Home
  • About
    • Endorsements
    • Published Articles
    • Consulting
    • Effective Pharmacotherapy
  • Pipeline News
    • Podcast
    • Recent Tweets
  • Pharmaceutical Pipeline Tracker
    • Access Pharmaceutical Pipeline Tracker
    • Pharmaceutical Pipeline Tracker Demo
    • Sample Drug Review
    • Case Studies >
      • Monitoring Drugs With PDUFA Dates
      • Monitoring Drugs By Therapeutic Category
      • Monitoring by Indication
      • Research a Single Drug
    • Sample Searches >
      • Single Drug Report Sample
      • Indication Search Sample
      • Drug Class Search Sample
      • Therapeutic Area Search Sample
      • Company Search Sample
  • COVID-19
    • COVID-19 Updates
    • COVID-19 Vaccines
    • COVID-19 Antivirals
    • COVID-19 Monoclonal Antibodies
    • COVID-19 Plasma Products
    • COVID-19 Anti-Inflammatories
    • Remdesivir
    • Ivermectin
  • Contact Us
  • Home
  • About
    • Endorsements
    • Published Articles
    • Consulting
    • Effective Pharmacotherapy
  • Pipeline News
    • Podcast
    • Recent Tweets
  • Pharmaceutical Pipeline Tracker
    • Access Pharmaceutical Pipeline Tracker
    • Pharmaceutical Pipeline Tracker Demo
    • Sample Drug Review
    • Case Studies >
      • Monitoring Drugs With PDUFA Dates
      • Monitoring Drugs By Therapeutic Category
      • Monitoring by Indication
      • Research a Single Drug
    • Sample Searches >
      • Single Drug Report Sample
      • Indication Search Sample
      • Drug Class Search Sample
      • Therapeutic Area Search Sample
      • Company Search Sample
  • COVID-19
    • COVID-19 Updates
    • COVID-19 Vaccines
    • COVID-19 Antivirals
    • COVID-19 Monoclonal Antibodies
    • COVID-19 Plasma Products
    • COVID-19 Anti-Inflammatories
    • Remdesivir
    • Ivermectin
  • Contact Us
Pipeline News and Updates
Picture

September PDUFA Dates

8/29/2019

 
There are two drugs with September PDUFA dates: tenapanor, one of nine investigational Nephrology drugs and semaglutide, one of twenty-six investigational Endocrinology drugs.

Ardelyx’ tenapanor’s PDUFA Date is 9/12/2019, and is targeting hyperphosphatemia in dialysis patients, IBS with constipation. This NHE3 Inhibitor blocks the NHE3 transporter in the GI tract to reduce the absorption of dietary sodium, which reduces phosphate absorption and increases the amount of fluid in the gut. Tenapanor has the potential to reduce pill burden in reducing serum phosphorus, but may have a higher incidence of diarrhea. Research published in the March 7, 2019, Journal of the American Society of Nephrology concluded “Tenapanor significantly reduced elevated serum phosphate in patients with hyperphosphatemia receiving maintenance hemodialysis. Adverse effects were limited to those induced by its known mechanism of action, which increases stool sodium and water content.”

Novo Nordisk’s oral semaglutide has a September 20, 2019, PDUFA date. The drug is indicated for Type 2 Diabetes as a GLP-1 receptor agonist. The FDA approved the weekly subcutaneous injection on 12/5/17 for the treatment of Type 2 Diabetes. If approved, it would be the first oral GLP-1 receptor agonist and a potential game-changer for patients who wish to avoid an injection. Novo has announced the results from ten Phase III trials demonstrating a reduction in HbA1c and weight. Results of seven of the trials have been published. In June we provided a brief summary of the 10 trials. In the Pharmaceutical Pipeline Tracker, you will find additional information about trials and links to the seven published studies. The drug has been compared to placebo, empagliflozin, sitagliptin, liraglutide and dulaglutide with favorable results in the Phase III trials. A Phase II trial demonstrated similar efficacy with a daily oral tablet as achieved with a weekly injection of semaglutide. The adverse effect profile is similar to injectable GLP-1 receptor antagonists with nausea and vomiting being the most frequent ADR. There does not appear to be another oral drug in this class in the late stages of development. Lilly’s tirzepatide, an injectable GIP and GLP-1 receptor agonist is the most advanced drug behind oral semaglutide. 


Comments are closed.
    Stay informed, subscribe to the 
    ​
    Prescribe Right Pharmaceutical Pipeline Tracker
    Latest Tweets from Prescribe Right

    Archives

    January 2023
    December 2022
    October 2022
    September 2022
    August 2022
    July 2022
    June 2022
    May 2022
    April 2022
    March 2022
    February 2022
    January 2022
    December 2021
    November 2021
    October 2021
    September 2021
    August 2021
    July 2021
    June 2021
    May 2021
    April 2021
    March 2021
    February 2021
    January 2021
    December 2020
    November 2020
    October 2020
    September 2020
    August 2020
    July 2020
    June 2020
    May 2020
    April 2020
    March 2020
    February 2020
    January 2020
    December 2019
    November 2019
    October 2019
    September 2019
    August 2019
    July 2019
    June 2019
    May 2019
    April 2019
    March 2019
    February 2019
    January 2019
    December 2018
    November 2018
    October 2018
    September 2018
    August 2018
    June 2018
    May 2018
    April 2018
    March 2018
    February 2018
    January 2018
    December 2017
    November 2017
    October 2017
    September 2017
    August 2017
    August 2015

    RSS Feed

Services

Pharmaceutical Pipeline Tracker​
Consulting

Company

About
Blog
Tweets

Support

Contact
© COPYRIGHT 2015. ALL RIGHTS RESERVED.