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Serotonin, a crucial neurotransmitter synthesized by enterochromaffin cells, plays a cardinal role in regulating gastrointestinal (GI) motility. With over 90% of the body's total serotonin in the GI tract, its influence on digestive processes is profound. Serotonin is swiftly released upon various stimuli, such as food boluses or certain drugs, triggering intrinsic sensory neurons in the myenteric plexus and extrinsic vagal and spinal sensory neurons. This leads to the activation of the...
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Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
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Drug design is a dynamic field that involves discovering and developing new medications based on specific biological targets. This process heavily relies on structure-activity relationships (SAR) and quantitative structure-activity relationships (QSAR) to guide the design and optimization of efficient drugs.
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Related Experiment Video

Updated: Jun 6, 2025

Percutaneous Hepatic Perfusion PHP with Melphalan as a Treatment for Unresectable Metastases Confined to the Liver
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Seladelpar: First Approval.

Sheridan M Hoy1

  • 1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.

Drugs
|November 21, 2024
PubMed
Summary

Seladelpar, a selective PPARδ agonist, received accelerated US approval for primary biliary cholangitis (PBC). This oral treatment offers a new option for patients with inadequate response or intolerance to ursodeoxycholic acid.

Area of Science:

  • Pharmacology
  • Hepatology
  • Drug Development

Background:

  • Primary biliary cholangitis (PBC) is a chronic liver disease.
  • Existing treatments for PBC include ursodeoxycholic acid (UDCA).
  • Some patients exhibit inadequate response or intolerance to UDCA.

Purpose of the Study:

  • To summarize the development milestones of seladelpar.
  • To highlight the regulatory approval of seladelpar for PBC treatment.

Main Methods:

  • Review of seladelpar's development pathway.
  • Analysis of regulatory submission data for PBC.

Main Results:

  • Seladelpar, a selective peroxisome proliferator-activated receptor (PPAR)δ agonist, demonstrated efficacy.

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  • Accelerated approval granted in the USA on August 14, 2024, based on alkaline phosphatase (ALP) reduction.
  • Indications include combination therapy with UDCA or monotherapy for intolerant patients.

    • Conclusions:

    • Seladelpar represents a significant advancement in PBC treatment.
    • Continued approval is contingent on confirmatory studies verifying clinical benefit.
    • Regulatory assessments are ongoing in the EU and UK.