Petrelintide (ZP8396) (10mg)

Petrelintide is a potent, stable, long-acting human amylin analogue. The molecular-development publication describes optimization of chemical stability while preserving in vitro and in vivo activity, plus formulation at near-neutral pH, a characteristic supporting research into potential coformulation. In the two published Phase 1 trials, its half-life was approximately 10 days and dose proportionality was observed at steady state.

• Laboratory reconstitution reference: 3.0 mL bacteriostatic water → approximately 3.33 mg/mL concentration.
• Published Phase 1 trials: SAD subcutaneous arms of 0.04–2.4 mg and MAD arms of 0.6–9.0 mg, as reported in the publication.
• Concentration calculation: At 3.33 mg/mL, 1 unit = 0.01 mL ≈ 33.3 mcg on a U-100 scale.
• Regulatory status: Investigational compound; not approved by the FDA or EMA.

1. For a laboratory reference calculation, 3.0 mL of bacteriostatic water corresponds to a concentration of approximately 3.33 mg/mL for a 10 mg vial.
2. Gentle addition of solvent against the vial wall limits foaming.
3. Gentle swirling continues until the lyophilized material is fully dissolved.
4. Storage conditions are determined by the research-material protocol, not by approved product labeling.
5. Cloudiness or particles are grounds for discarding the research solution.

• Compound: Petrelintide (ZP8396), Zealand Pharma's long-acting human amylin analogue.
• Regulatory status: In clinical development; not an approved medicine.
• Phase 1 SAD: Subcutaneous arms of 0.04–2.4 mg and a separate 0.35 mg intravenous arm.
• Phase 1 MAD part 1: Six once-weekly doses in the 0.6 mg and 1.2 mg arms.
• Phase 1 MAD part 2: Sixteen once-weekly doses with escalation every 2 weeks toward the 2.4, 4.8, and 9.0 mg research targets.
• Laboratory reference: 3.0 mL per hypothetical 10 mg vial (~3.33 mg/mL).

• SAD: The publication reports a single subcutaneous dose of 0.04–2.4 mg and a separate 0.35 mg intravenous dose.
• MAD part 1: The publication reports six once-weekly doses of 0.6 mg or 1.2 mg.
• MAD part 2: The publication reports sixteen once-weekly doses, with escalation every 2 weeks toward the 2.4, 4.8, or 9.0 mg research targets.
• Phase 1 outcome: Bodyweight change of up to −8.6% was reported after 16 weeks in MAD part 2.
• Interpretation: These are published outcomes from specific research arms, not instructions for use.
• Break between cycles: A 2–4 week break is recommended before repeating the cycle.

• There is no approved product labeling with standardized storage conditions for petrelintide.
• The molecular-development publication describes a stable analogue that can be formulated at near-neutral pH.
• Storage and stability conditions depend on the specific research material and laboratory protocol.

• Petrelintide is an investigational compound and is not approved by the FDA or EMA.
• Published human evidence comes from early Phase 1 trials.
• Numerical values on this page exclusively reproduce arms and outcomes from the cited trials.

1. Diabetes, Obesity and Metabolism (2026) — Two randomized, controlled Phase 1 trials of petrelintide
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2. Journal of Medicinal Chemistry (2025) — Molecular development of stable, long-acting petrelintide
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3. ClinicalTrials.gov — Renal impairment — NCT07076030
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4. ClinicalTrials.gov — Hepatic impairment — NCT07682818
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5. ClinicalTrials.gov — Phase 2 with enicepatide — NCT07589686
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