Product Timelines

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Product Timelines

Elagolix was approved by the FDA in July 2018 while Linzagolix has not being approved by the FDA and the development of Opigolix has been discontinued. The requested information on the clinical trial dates, FDA approval, and FDA submission dates for these drugs have been outlined below.

Elagolix (created by AbbVie pharmaceuticals)

  • AbbVie (at the time, Abbott) and Neurocrine Biosciences entered into a partnership to created Elagolix in June 2010.
  • Per the terms of the agreement, AbbVie will have exclusive rights to "develop and commercialise Elagolix."
  • A New Drug Application (NDA) for elagolix was received by the FDA on August 23, 2017.
  • Elagolix was approved by the FDA on July 23, 2018.
  • A phase 2 randomized clinical trial study for its treatment of endometriosis-associated pain began in April 2005 and was completed by June 2006.
  • A phase 3 randomized clinical trial for Elagolix in Endometriosis began on December 28, 2012 and was completed on April 15, 2016.

Linzagolix (also known as "OBE-2109," created by ObsEva and Kissei)

  • Linzagolix was submitted to the FDA in May 2016.
  • Linzagolix has not being approved by the FDA, however, it is currently being evaluated in phase 3 randomized clinical trials.
  • A phase 2 randomized clinical trial for the efficacy and safety of Linzagolix in patients with heavy menstrual bleeding started in July 2016 and ended in April 2018.
  • A phase 3 randomized clinical trial for the efficacy of Linzagolix in individuals with endometriosis began on May 23, 2017, and is still ongoing. It is expected to be completed by March 2020.

Opigolix (created by Astellas)

  • Opigolix has not been approved by the FDA.
  • Astellas Pharma announced the development of Opigolix in March 2018.
  • On the 24th of June 2018, biomarker details was updated on Opigolix.
  • In April 2018, a phase 1 clinical trial began for the efficacy of Opigolix in subjects with rheumatoid arthritis but this study was stopped and has been discontinued.
  • A phase 2 clinical trial for the efficacy of Opigolix in subjects with endometriosis located in Europe and Japan also began in April 2018. This study has also been discontinued.
  • The development of Opigolix was discontinued by April 30, 2018. This means that there are no plans for a phase 3 randomized clinical trial.

RESEARCH STRATEGY:

In order to figure out the FDA approval dates for Elagolix, Linzagolix, and Opigolix, we mainly relied on FDA databases like Access Data. There, no results came up for Linzagolix and Opigolix. Knowing that this might be an indication that the drugs have not been approved by the FDA, we turned to the official websites of the companies developing these drugs. We found that these companies provided no information on the FDA approval of their drugs. We then examined their press releases and annual reports. Through these mediums, we were able to conclude that they have not approved by the FDA. The same approach was carried out to find the dates of FDA submission and randomized clinical trials of the drugs. To get a breakdown of the randomized clinical trials (RCT) for Elagolix, Linzagolix, and Opigolix, we leveraged a clinical trial database managed by the US National Library of Medicine.

Sources
Sources