PPAR-δ agonist Pregnancy: US §8.1: insufficient data from human pregnancies to assess a drug-associated risk of major birth defects, miscarriage or other adverse maternal/fetal outcomes. In animal reproduction studies no malformations or effects on embryo-fetal survival occurred in rats or rabbits at exposures up to 176-times and 49-times the recommended dose by AUC respectively; reduced fetal growth associated with maternal toxicity occurred in rabbits at 49-times the recommended dose.

Seladelpar

Brand names: Livdelzi

Seladelpar is a PPAR-delta agonist used for primary biliary cholangitis, typically in combination with or as an alternative to ursodeoxycholic acid in adults with an inadequate response or intolerance.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 10 mg

Route: Oral

Frequency: Once daily

US prescribing information (LIVDELZI, 10 mg capsules) §2.1: the recommended dosage is 10 mg orally once daily, with or without food. §2.2: administer at least 4 hours before or 4 hours after taking bile acid sequestrants, or at as great an interval as possible. No eMC/UK SPC was available in the source bundle — this is US labelling only and must be verified against UK licensing and indication (primary biliary cholangitis per the US label). Obtain baseline clinical and laboratory liver assessments before starting and monitor during treatment; interrupt or discontinue if liver tests worsen (§5.2). Avoid use in patients with complete biliary obstruction; if biliary obstruction is suspected, interrupt and treat as clinically indicated (§5.3). Elderly: no dosage adjustment necessary for patients 65 years and older; closer monitoring of adverse events recommended in patients older than 75 years. Paediatric: safety and effectiveness in paediatric patients have not been established (§8.4) — no paediatric dose stated.

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

None stated (US label §4 CONTRAINDICATIONS: "None")

Side effects

Headache
Abdominal pain
Nausea
Abdominal distension
Dizziness
Fractures (occurred in 4% of treated patients vs none on placebo) — consider fracture risk and monitor bone health
Liver test abnormalities (dose-related transaminase increases)

Interactions

Probenecid — avoid concomitant use (increases seladelpar exposure)
Strong CYP2C9 inhibitors — monitor for adverse effects
Dual moderate CYP2C9 and moderate or strong CYP3A4 inhibitors (e.g. fluconazole) — monitor for adverse effects
CYP2C9 poor metabolisers using moderate to strong CYP3A4 inhibitors — monitor for adverse effects
Dual or multiple clinical inhibitors of the drug transporters OATP1B1, OATP1B3 and BCRP — monitor for adverse effects
Rifampin — monitor biochemical response (e.g. ALP and bilirubin) when rifampin is initiated
Bile acid sequestrants — administer seladelpar at least 4 hours before or 4 hours after, or at as great an interval as possible

Clinical monograph

How it works

By activating peroxisome proliferator-activated receptor delta, it reduces hepatic bile acid synthesis and exerts anti-cholestatic and anti-inflammatory effects.

Prescribing in practice

It should not be used in patients with decompensated cirrhosis, and liver biochemistry must be assessed before and during treatment because of the risk of hepatic adverse effects.
Myalgia and musculoskeletal effects have been reported, so investigate new or worsening muscle symptoms.
Treatment response is judged on biochemical markers of cholestasis according to the SPC and current prescribing references.

Monitoring

Monitor liver function tests at baseline and periodically during treatment, and assess biochemical response to therapy.

Counselling the patient

Attend for the blood tests needed to monitor your liver.
Report unexplained muscle pain, dark urine, or yellowing of the skin or eyes.

Evidence & guidelines

Seladelpar is a second-line treatment option for primary biliary cholangitis in patients with inadequate response to ursodeoxycholic acid.

Reference: SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Pathways