JOENJA Film-coated tablet Ref.[116590] Active ingredients: Leniolisib

Source: European Medicines Agency (EU)  Revision Year: 2026  Publisher: Pharming Technologies B.V., Darwinweg 24, 2333 CR Leiden, The Netherlands

Product name and form

Joenja 70 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Yellow, oval-shaped, biconvex, bevelled edge film-coated tablet debossed with "70" on one side and "LNB" on the other side, approximately 16 mm in length, 6.3 mm in width, and 6.0 mm in thickness.

Qualitative and quantitative composition

Each film-coated tablet contains leniolisib phosphate equivalent to 70 mg leniolisib.

Excipient with known effect:

Each film-coated tablet contains 241.16 mg of lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient

Leniolisib inhibits PI3K-delta by blocking the active binding site of PI3K-delta. In cell-free isolated enzyme assays, leniolisib was selective for PI3K-delta over PI3K-alpha (28-fold), PI3K-beta (43-fold), and PI3K-gamma (257-fold), as well as the broader kinome. In cell-based assays, leniolisib reduced pAkt pathway activity and inhibited proliferation and activation of B and T cell subsets.

List of Excipients

Tablet core:

Lactose monohydrate
Microcrystalline cellulose (E460)
Hypromellose (E464)
Sodium starch glycolate (Type A)
Magnesium stearate (E572)
Colloidal anhydrous silica (E551)

Tablet film-coating:

Hypromellose (E464)
Titanium dioxide (E171)
Iron oxide monohydrate yellow (E172)
Iron oxide red (E172)
Talc (E553b)
Polyethylene glycol (E1521)

Pack sizes and marketing

High density polyethylene bottles with aluminium induction seal and child resistant polypropylene screw cap.

Each pack contains 1 bottle with 60 tablets.

Marketing authorization holder

Pharming Technologies B.V., Darwinweg 24, 2333 CR Leiden, The Netherlands

Marketing authorization dates and numbers

EU/1/26/2034/001

Drugs

Drug Countries
JOENJA United States

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.