Leniolisib is a kinase inhibitor indicated for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 4 years of age and older who weigh 27 kg or greater. MedsAcross supplies Leniolisib for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
JOENJA is indicated for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 4 years of age and older who weigh 27 kg or greater. JOENJA is a kinase inhibitor indicated for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 4 years of age and older who weigh 27 kg or greater.
Source: US FDA prescribing information
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. Gain-of-function variants in the gene encoding the p110-delta catalytic subunit or loss of function variants in the gene encoding the p85-alpha regulatory subunit each cause hyperactivity of PI3K-delta. Leniolisib inhibits the signaling pathways that lead to increased production of PIP3, hyperactivity of the downstream mTOR/Akt pathway, and to the dysregulation of B and T cells.
Source: US FDA prescribing information
Verify pregnancy status in females of reproductive potential prior to initiating treatment. Recommended Dosage is based on weight and JOENJA is administered orally twice daily approximately 12 hours apart, with or without food. Recommended Dosage in Adult and Pediatric Patients 4 Years of Age and Older Who Weigh 27 kg or Greater Age Body Weight Recommended Oral Dosage 4 years to less than 12 years of age 27 kg to less than 38 kg 40 mg twice daily 38 kg to less than 45 kg 50 mg twice daily 45 kg or greater 70 mg twice daily 12 years of age and older Any weight 70 mg twice daily
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Embryo-Fetal Toxicity: JOENJA may cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. Vaccinations: Live, attenuated vaccinations may be less effective if administered during JOENJA treatment. Risk of Hypersensitivity Reactions, Including Anaphylaxis: Hypersensitivity reactions, including anaphylaxis have been reported in the postmarketing setting. If hypersensitivity reactions occur, discontinue JOENJA and institute appropriate therapy.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: Risk of Hypersensitivity Reactions, Including Anaphylaxis Most common adverse reactions (incidence > 10%): Adult and Pediatric Patients 12 Years of Age and Older: headache, sinusitis, and atopic dermatitis. Pediatric Patients 4 Years to < 12 Years of Age Who Weigh 27 kg or Greater: abdominal pain, cough, and respiratory tract infection.
Source: US FDA prescribing information
Strong CYP3A4 Inhibitors: Avoid concomitant use. Strong and Moderate CYP3A4 Inducers: Avoid concomitant use. BCRP, OATP1B1, and OATP1B3 Substrates: Avoid concomitant use.
Source: US FDA prescribing information
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F). Do not refrigerate.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
3 presentations of Leniolisib, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Joenja 40 mg tabletOral | Pharming Healthcare | US FDA | Available on request |
| Joenja 50 mg tabletOral | Pharming Healthcare | US FDA | Available on request |
| Joenja 70 mg tabletOral | Pharming Healthcare | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 3 presentations of Leniolisib and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Leniolisib, including Joenja.
Yes. The US FDA first approved Leniolisib on 24 March 2023, according to Drugs@FDA.
Yes. Leniolisib has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Leniolisib is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Leniolisib is classified under ATC code L03AX22 (Leniolisib).
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