Product image of Iqirvo (Elafibranor) supplied by GNH India

Iqirvo

Active Ingredient:
Elafibranor
Origin:
EU

Iqirvo (Elafibranor)

Elafibranor, the active ingredient in Iqirvo, is a PPAR α/δ agonist presented as an oral formulation for oral use. It is indicated for the treatment of primary biliary cholangitis in adults, targeting metabolic and inflammatory pathways to help manage liver disease progression.
GNH India supplies Iqirvo as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Ipsen Pharma

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Indications & Clinical Uses

  • Iqirvo (elafibranor) is indicated for the treatment of primary biliary cholangitis, a chronic autoimmune liver disease characterized by progressive destruction of intra‑hepatic bile ducts and associated inflammation and fibrosis. The drug targets metabolic and inflammatory pathways to modify disease progression.
  • Primary biliary cholangitis: helps reduce liver inflammation and fibrosis, aiming to improve biochemical markers of disease activity.

How It Works

  • Elafibranor activates peroxisome proliferator‑activated receptors alpha (PPARα) and delta (PPARδ) in hepatocytes and immune cells. Activation of these nuclear receptors modulates lipid metabolism, reduces inflammatory cytokine production, and interferes with fibrogenic signaling pathways, thereby contributing to improved liver function and decreased fibrotic progression in chronic cholestatic disease.

Side Effects

Common Side Effects

  • Nausea: mild to moderate stomach upset.
  • Diarrhea: increased bowel movements.
  • Abdominal pain: discomfort in the upper abdomen.
  • Headache: transient head pain.
  • Pruritus: itching sensation.
  • Fatigue: feeling of tiredness.

Serious or Rare Side Effects

  • Elevated liver enzymes: may indicate hepatic injury.
  • Severe allergic reaction: rash, swelling, or anaphylaxis.
  • Pancreatitis: inflammation of the pancreas.
  • Hepatic decompensation: worsening liver function.
  • Acute renal failure: sudden loss of kidney function.
  • Thromboembolic events: blood clot formation.

Precautions & Warnings

Before initiating therapy, clinicians should consider several safety measures.

  • Monitor liver function: perform baseline and periodic liver enzyme tests.
  • Assess cardiovascular risk: evaluate for existing heart disease.
  • Evaluate renal function: adjust use in patients with severe impairment.
  • Review concomitant medications: check for potential interactions.
  • Avoid in patients with known hypersensitivity to elafibranor.
  • Store at ambient temperature: keep in the original pack, protect from moisture and light.

Avoid Interactions

Elafibranor may interact with other medicines, requiring careful management.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors: may increase elafibranor exposure.
  • Strong CYP3A4 inducers: may reduce therapeutic effect.
  • Bile acid sequestrants: can lower absorption of the drug.

Moderate Interactions (Monitor Closely)

  • Statins: monitor for increased muscle toxicity.
  • Anticoagulants: watch for altered clotting parameters.
  • Oral contraceptives: may affect hormonal efficacy.
  • Antidiabetic agents: monitor blood glucose levels.
  • NSAIDs: assess for additive gastrointestinal risk.

Frequently Asked Questions

Iqirvo (elafibranor) is prescribed for adults with primary biliary cholangitis, an autoimmune condition that causes progressive damage to the bile ducts in the liver. The medication aims to reduce inflammation and fibrosis, helping to stabilize liver function and improve disease‑related laboratory markers.

Elafibranor activates the nuclear receptors PPARα and PPARδ, which regulate genes involved in lipid metabolism, inflammation, and fibrogenesis. By stimulating these receptors, the drug promotes fatty‑acid oxidation, lowers inflammatory cytokine production, and interferes with pathways that lead to liver scarring, thereby supporting healthier liver tissue.

The dose of Iqirvo is determined by the prescribing clinician based on the individual patient's clinical status, liver function, and other relevant factors. Healthcare professionals tailor the regimen to achieve optimal therapeutic effect while monitoring safety, and patients should follow the prescriber’s specific instructions.

Safety of elafibranor in pregnancy and lactation has not been fully established. It should only be used if the potential benefit to the mother outweighs any possible risk to the fetus or infant. Women who are pregnant, planning to become pregnant, or breastfeeding should discuss alternatives with their healthcare provider.

To place an order, submit an enquiry on the Iqirvo product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, and will request trade or institutional credentials. After verification, the team provides pricing, availability, shipping details (including any cold‑chain needs), and assists with import documentation.

The primary approved therapy for primary biliary cholangitis is ursodeoxycholic acid (UDCA). While UDCA improves bile flow and liver enzymes, elafibranor targets metabolic and inflammatory pathways through PPAR activation, offering a complementary mechanism that may benefit patients with an inadequate response to UDCA. Clinical decisions depend on individual disease severity and response.

Iqirvo should be stored at ambient temperature, preferably below 25 °C. Keep the product in its original packaging to protect it from moisture and light. Do not store in areas with high humidity or direct sunlight, and ensure the container remains tightly closed when not in use.

Iqirvo is taken orally, usually as a tablet or capsule, with or without food as directed by the prescriber. Patients should swallow the dose whole with a full glass of water and follow any specific timing instructions provided by their healthcare professional.

Serious risks include significant elevations in liver enzymes indicating possible hepatic injury, severe allergic reactions such as anaphylaxis, and rare cases of hepatic decompensation or pancreatitis. Patients should be monitored regularly for signs of liver dysfunction, rash, swelling, or abdominal pain, and report any concerning symptoms promptly.

Iqirvo is contraindicated in individuals with known hypersensitivity to elafibranor or any of its excipients. It should also be avoided in patients with severe liver impairment, uncontrolled cardiovascular disease, or those taking medications that have a major interaction risk without appropriate monitoring. Clinicians must assess each patient’s medical history before prescribing.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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