Is Pirtobrutinib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Pirtobrutinib, including Jaypirca (100 mg, Tablet, SAR 20872.50); Jaypirca (50 mg, Tablet, SAR 10436.25).

Is Pirtobrutinib approved by the US FDA?

Drugs@FDA lists 1 application product line for Pirtobrutinib, including JAYPIRCA (Prescription).

Is Pirtobrutinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Pirtobrutinib: Jaypirca.

Are there safety signals or safety updates for Pirtobrutinib?

US FDA: 1 entry (latest 2026-10-02).

Active substance

Pirtobrutinib

SFDA 3
US FDA 1
EMA 1
Health Canada 2
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Jaypirca	100 mg	Tablet · Oral use	30 Bottle	SAR 20872.50	NCE · Prescription	Eli Lilly and Company	Valid
Jaypirca	50 mg	Tablet · Oral use	30 Bottle	SAR 10436.25	NCE · Prescription	Eli Lilly and Company	Valid
Jaypirca	100 mg	Tablet · Oral use	60 Bottle	SAR 41745.00	NCE · Prescription	Eli Lilly and Company	Valid

Indications — CHI Daman Drug Formulary

MANTLE CELL LYMPHOMA; SMALL LYMPHOCYTIC LYMPHOMA

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
JAYPIRCA	50MG; 100MG	tablet · oral	LOXO ONCOL	Prescription	27 Jan 2023

EMA European Union — centrally authorised medicines

Jaypirca Eli Lilly Nederland B.V. · Authorised · authorised 30 Oct 2023 · ATC L01

Therapeutic indication (EMA)

Jaypirca as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have been previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor. Jaypirca as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
JAYPIRCA	02562006	50 MG	TABLET · ORAL	ELI LILLY CANADA INC
JAYPIRCA	02562014	100 MG	TABLET · ORAL	ELI LILLY CANADA INC

Safety signals and safety-related labeling changes

US FDA 2 Oct 2026 JAYPIRCA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for pirtobrutinib →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.