Seladelpar: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: December 18, 2025🚩 Report this page

Seladelpar

Other Drugs For Bile Therapy

Sold as LYVDELZI

CA Health Canada

Drug class: Other Drugs For Bile Therapy
Availability: See label
Routes: Oral
Markets covered: 1
Products on record: 1

Overview

Seladelpar is an active pharmaceutical ingredient in the Other Drugs For Bile Therapy group (A05AX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
CA Canada	Health Canada	1	December 18, 2025

CACanada· Health Canada

1 product

Uses

CAOfficial regulatory label· revised December 18, 2025[1]

LYVDELZI (seladelpar) is indicated for the treatment of primary biliary cholangitis (PBC), in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA alone, or as monotherapy in adults unable to tolerate UDCA.
Marketing authorization with conditions for this indication is based on a randomized, placebo-controlled, phase III study that assessed alkaline phosphatase (ALP) and bilirubin as a composite biochemical surrogate endpoint [see 14 CLINICAL TRIALS].
Continued approval for this indication is contingent upon verification of clinical benefit in a confirmatory trial(s). 1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
2 Geriatrics Geriatrics (≥ 65 years of age): Evidence from clinical studies and experience suggests that use in patients 65 to 75 years old is not associated with differences in safety or effectiveness. There is limited clinical experience in patients older than 75 years.

Sources & citations

[1]Health Canada (DPD) · 02561492 · revised December 18, 2025

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

How to take

CAOfficial regulatory label· revised December 18, 2025[1]

1 Dosing Considerations Obtain baseline liver clinical and laboratory assessments at treatment initiation with LYVDELZI. See 7 WARNINGS AND PRECAUTIONS. 2 Recommended Dose and Dosage Adjustment The recommended dosage of LYVDELZI is 10 mg taken orally once daily with or without food.
Pediatrics (<18 years of age) The safety and efficacy of LYVDELZI in patients younger than 18 years of age have not been established. Health Canada has not authorized an indication for pediatric use. Geriatrics (>65 years of age) No dose adjustment of LYVDELZI is required for elderly patients.
Product Monograph Page 5 of 27 LYVDELZI seladelpar capsules Renal Impairment No dose adjustment of LYVDELZI is required in patients with mild, moderate, or severe renal impairment (estimated glomerular filtration rate [eGFR] ≥ 15 mL/min).
LYVDELZI has not been studied in patients with end stage renal disease (ESRD) on dialysis. Hepatic Impairment No dose adjustment of LYVDELZI is required in patients with mild hepatic impairment (Child-Pugh A). The safety and efficacy of LYVDELZI in patients with decompensated cirrhosis have not been established.
Monitor patients with cirrhosis for evidence of decompensation. Consider discontinuing LYVDELZI if the patient progresses to moderate or severe hepatic impairment (Child-Pugh B or C). Use of LYVDELZI is not recommended in patients who have or develop decompensated cirrhosis.
4 Administration The recommended dose of LYVDELZI is one capsule (10 mg) taken orally once daily with or without food. Administer LYVDELZI at least 4 hours before or 4 hours after taking a bile acid sequestrant, or at as great an interval as possible.
4 Drug-Drug Interactions. 5 Missed Dose If a dose of LYVDELZI is missed, the missed dose should be taken at the next scheduled time point. A double dose should not be taken to make up for the missed dose.

This is not medical advice. Consult a qualified healthcare professional.

Side effects & warnings

CAOfficial regulatory label· Adverse reactions· revised December 18, 2025[1]

1 Adverse Reaction Overview Assessment of adverse reactions is based on data from the pivotal study (CB8025-32048 [RESPONSE]) in which 128 patients with PBC received 10 mg LYVDELZI once daily. 3%). No severe adverse events occurred in >1% of patients treated with LYVDELZI in RESPONSE.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse event rates observed in the clinical trials, therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse event information from clinical trials may be useful in identifying and approximating rates of adverse drug events in real-world use. In the Phase 3 study (CB8025-32048 [RESPONSE]), 193 patients were randomized (2:1) to receive either LYVDELZI 10 mg (n=128) or placebo (n=65) once daily for 52 weeks.
3 weeks in the LYVDELZI and placebo groups respectively. LYVDELZI or placebo was administered in combination with UDCA in 94% of patients and as monotherapy in 6% of patients who were unable to tolerate UDCA. 2% in the placebo arm. A total of 118 patients completed 1 year of treatment with LYVDELZI 10 mg.
The most common adverse reactions occurring in ≥ 5% of patients and with greater frequency than Product Monograph Page 9 of 27 LYVDELZI seladelpar capsules placebo in the LYVDELZI treatment arm are shown in Table 2. 3 Less Common Clinical Trial Adverse Reactions (<5%) Adverse reactions occurring at a frequency of <5% of patients are presented below.
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Serum Creatinine Dose dependent increases in serum creatinine have been observed in LYVDELZI-treated patients. 2% in patients taking placebo.
Reductions in eGFR of at least 25% associated with increases in serum creatinine were observed in 10% (n=12) of LYVDELZI-treated patients, compared to 2% (n=1) of placebo-treated patients. Increases in serum creatinine and declines in eGFR were not progressive and returned towards baseline with ongoing LYVDELZI treatment.
None of the patients experienced an eGFR decline of 50% or more. None of the patients required discontinuation of LYVDELZI and there were no clinical findings associated with the observed changes in serum creatinine or eGFR.

CAOfficial regulatory label· Warnings and precautions· revised December 18, 2025[1]

2 Recommended Dose and Dosage Adjustment The recommended dosage of LYVDELZI is 10 mg taken orally once daily with or without food. Pediatrics (<18 years of age) The safety and efficacy of LYVDELZI in patients younger than 18 years of age have not been established.
Health Canada has not authorized an indication for pediatric use. Geriatrics (>65 years of age) No dose adjustment of LYVDELZI is required for elderly patients. Product Monograph Page 5 of 27 LYVDELZI seladelpar capsules Renal Impairment No dose adjustment of LYVDELZI is required in patients with mild, moderate, or severe renal impairment (estimated glomerular filtration rate [eGFR] ≥ 15 mL/min).
LYVDELZI has not been studied in patients with end stage renal disease (ESRD) on dialysis. Hepatic Impairment No dose adjustment of LYVDELZI is required in patients with mild hepatic impairment (Child-Pugh A). The safety and efficacy of LYVDELZI in patients with decompensated cirrhosis have not been established.
Monitor patients with cirrhosis for evidence of decompensation. Consider discontinuing LYVDELZI if the patient progresses to moderate or severe hepatic impairment (Child-Pugh B or C). Use of LYVDELZI is not recommended in patients who have or develop decompensated cirrhosis.
4 Administration The recommended dose of LYVDELZI is one capsule (10 mg) taken orally once daily with or without food. Administer LYVDELZI at least 4 hours before or 4 hours after taking a bile acid sequestrant, or at as great an interval as possible.
4 Drug-Drug Interactions. 5 Missed Dose If a dose of LYVDELZI is missed, the missed dose should be taken at the next scheduled time point. A double dose should not be taken to make up for the missed dose. 5 OVERDOSAGE PBC patients who received 5-times the recommended dosage or 20-times the recommended dosage of LYVDELZI experienced an increase in liver transaminases, muscle pain, and/or elevations in creatine phosphokinase, which resolved upon LYVDELZI discontinuation [see 7 WARNINGS AND PRECAUTIONS].
There is no specific treatment for overdose with LYVDELZI. General supportive care of the patient is indicated, as appropriate. If indicated, elimination of unabsorbed drug should be achieved by emesis or gastric lavage. Because seladelpar is highly bound to plasma proteins, hemodialysis should not be considered.

This is not medical advice. Consult a qualified healthcare professional.

Overview

Regulatory status by market

CACanada· Health Canada

Drugs in the same class

Sources & citations