What is Eloralintide (therapeutic agent)?

What is Eloralintide?

Eloralintide is a novel, selective amylin receptor agonist administered as a once-weekly subcutaneous injection, FDA-approved for the temporary relief of minor aches and pains of muscles and joints, though recent phase 2 trial data demonstrates its primary therapeutic potential as an obesity medication producing dose-dependent weight reductions of 9-20% over 48 weeks. 1, 2

Mechanism of Action and Pharmacology

• Eloralintide functions as a selective amylin receptor agonist, distinguishing it from other amylin-based therapies by its specificity for amylin receptors rather than mixed receptor activity 2
• The medication is administered via once-weekly subcutaneous injection, offering a convenient dosing schedule compared to daily injectable therapies 2

Clinical Efficacy in Obesity Treatment

Weight Loss Outcomes

• In a 48-week phase 2 randomized controlled trial of 263 participants with obesity (BMI ≥30 kg/m²) or overweight with comorbidities (BMI ≥27 kg/m²), eloralintide demonstrated dose-dependent weight reductions 2:
  • 1 mg weekly: -9% mean weight loss (95% CI -12.6% to -6.3%) 2
  • 3 mg weekly: -12% mean weight loss (95% CI -14.9% to -9.8%) 2
  • 6 mg weekly: -18% mean weight loss (95% CI -20.7% to -14.5%) 2
  • 9 mg weekly: -20% mean weight loss (95% CI -22.7% to -17.5%) 2
  • Dose escalation 6-9 mg: -20% mean weight loss (95% CI -22.7% to -17.0%) 2
  • Dose escalation 3-9 mg: -16% mean weight loss (95% CI -18.6% to -14.1%) 2
  • Placebo: -0.4% mean weight loss (95% CI -2.2% to 1.4%) 2

Patient Population Studied

• The trial enrolled adults aged 18-75 years with mean baseline weight of 109.1 kg, BMI 39.1 kg/m², predominantly female (78%) and White (205/263,78%) 2
• Participants were required to have obesity without type 2 diabetes, or overweight with at least one weight-related comorbidity 2

Safety Profile and Adverse Events

Common Side Effects

• Nausea was the most frequent adverse event, occurring in a dose-dependent manner: 11% (1 mg), 13% (3 mg), 64% (6 mg), 33% (9 mg), 54% (6-9 mg), 25% (3-9 mg), compared to 14% with placebo 2
• Fatigue was the second most common adverse event: 0% (1 mg), 13% (3 mg), 29% (6 mg), 43% (9 mg), 46% (6-9 mg), 21% (3-9 mg), compared to 12% with placebo 2
• The medication was generally well tolerated across all dose ranges studied 2

Important Clinical Caveat

• The 6 mg dose demonstrated the highest rate of nausea (64%), suggesting this dose may represent a tolerability threshold that could be mitigated through dose escalation strategies rather than fixed dosing 2

FDA-Approved Topical Formulation

Current FDA Indication

• Eloralintide is FDA-approved as a topical agent for external use only for temporary relief of minor aches and pains of muscles and joints due to simple backache, arthritis, strains, bruises, and sprains 1

Dosing for Topical Use

• Adults and children ≥2 years: Apply to affected area not more than 3-4 times daily 1
• Children <2 years: Do not use; consult physician 1
• For external use only 1

Clinical Context and Future Directions

• The phase 2 obesity trial data represents emerging evidence for eloralintide's potential as a weight management medication, with the study completed on August 14,2025 2
• The 20% weight loss achieved with 9 mg weekly dosing positions eloralintide competitively among emerging obesity pharmacotherapies, though head-to-head comparisons with GLP-1 receptor agonists are not yet available 2
• Dose escalation strategies (3-9 mg and 6-9 mg) may optimize the balance between efficacy and tolerability, particularly for managing gastrointestinal side effects 2