Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

An open-label, non-randomized extension study to evaluate the long term safety, tolerability, efficacy and pharmacokinetics of CDZ173 in patients with APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/p110δ- activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency)

Next Previous
X
Search
Trial Profile

An open-label, non-randomized extension study to evaluate the long term safety, tolerability, efficacy and pharmacokinetics of CDZ173 in patients with APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/p110δ- activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency)

Status: Active, no longer recruiting
Phase of Trial: Phase II/III

Latest Information Update: 08 Jun 2024

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Leniolisib (Primary)
  • Indications Immunodeficiency disorders; Lymphadenopathy
  • Focus Adverse reactions; Registrational
  • Sponsors Pharming Group NV

    • Most Recent Events

    • 30 May 2024 According to Pharming Group NV media release, the CHMP review is ongoing and following the May 27-30 CHMP meeting, Pharming received an updated List of Outstanding Issues from the CHMP. The LoOI affirmed the positive clinical benefit and safety of leniolisib, in agreement with the assessment by the Ad Hoc Expert Group, and included one remaining CMC. The CMC request relates to the definition of regulatory starting materials used in the manufacturing of leniolisib.
    • 21 Feb 2023 According to Pharming Group NV media release, the company has received the positive opinion from the Europeans Medicines Agency (EMA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) on the Pediatric Investigation Plan (PIP) for leniolisib as treatment for APDS in children.
    • 16 Feb 2023 According to Pharming Group N.V media release, based on the timetable for our responses, Pharming expects that CHMP will issue its opinion on the leniolisib MAA in 2H 2023.

You need to be a logged in or subscribed to view this content Request demo

If your organization or you do not have a subscription, try one of the following:
  • Contacting your organization’s admin about adding this content to your AdisInsight subscription
  • Buying a PDF version of any individual profile
  • Request a free trial
If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top