Glepaglutide: Dosing Protocols
Dosing guidelines, reconstitution, and administration information
๐TL;DR
- โข1 dosing protocols documented
- โขReconstitution instructions included
- โขStorage: Store refrigerated at 2-8 degrees C. The ready-to-use formulation has demonstrated acceptable stability for the shelf life required for commercial use. Protect from light. Do not freeze.
Protocol Quick-Reference
Short bowel syndrome with intestinal failure
Dosing
Amount
10 mg
Frequency
Twice weekly
Duration
Ongoing
Step-wise Titration
Administration
Route
SCSchedule
Twice weekly (every 3-4 days)
Timing
Consistent schedule every 3-4 days; no dose titration required
โ Rotate injection sites
Cycle
Duration
Ongoing
Repeatable
Yes
Preparation & Storage
โ Ready-to-use โ no reconstitution required
Storage: Refrigerate at 2-8 degrees C. Protect from light.
โ๏ธ Suggested Bloodwork (4 tests)
When:
Why:
When:
Why:
When:
Why:
When:
Why:
๐ก Key Considerations
- โInvestigational drug - not approved by any regulatory authority
- โOnly twice-weekly dosing showed significant efficacy in phase 3
- โNo dose adjustment needed for renal impairment
- โPS volume should be reduced gradually under medical supervision as intestinal absorption improves
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| Purpose | Dose | Frequency | Duration | Notes |
|---|---|---|---|---|
| Short Bowel Syndrome with Intestinal Failure (Phase 3 Protocol) | 10 mg subcutaneously twice weekly (every 3-4 days). This was the dosing regimen that met the primary endpoint in the EASE SBS 1 trial. | Twice weekly subcutaneous injection | Ongoing (24 weeks in the pivotal trial; 52 weeks in extension study) | Once-weekly dosing of 10 mg was also tested but did not achieve statistical significance vs placebo. Twice-weekly dosing is the regimen supported by phase 3 data. |
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๐Reconstitution Instructions
Glepaglutide is formulated as a ready-to-use liquid solution in an autoinjector device. No reconstitution is required, which represents a significant practical advantage over teduglutide (which requires daily reconstitution from lyophilized powder). This was a deliberate design goal enabled by the chemical stability of glepaglutide in aqueous solution.
Recommended Injection Sites
- โAbdomen
- โThigh
๐งStorage Requirements
Store refrigerated at 2-8 degrees C. The ready-to-use formulation has demonstrated acceptable stability for the shelf life required for commercial use. Protect from light. Do not freeze.
Community Dosing Protocols
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Before You Begin
Review safety warnings and contraindications before starting any protocol.
Investigational Status#
Glepaglutide (ZP1848) is an investigational medication that has not received regulatory approval. The FDA issued a Complete Response Letter in December 2024 requesting additional clinical data. All dosing information is derived from clinical trial protocols and published results. Administration should only occur within the context of clinical trials.
Clinical Trial Dosing#
EASE SBS 1 (Phase 3)#
The pivotal phase 3 trial tested two dosing regimens against placebo:
Twice-Weekly Regimen (met primary endpoint):
- Dose: 10 mg subcutaneously
- Frequency: Twice weekly (every 3-4 days)
- Duration: 24 weeks
- This was the only regimen that achieved statistical significance
Once-Weekly Regimen (did not meet primary endpoint):
- Dose: 10 mg subcutaneously
- Frequency: Once weekly
- Duration: 24 weeks
- Did not significantly differ from placebo on primary or key secondary endpoints
Phase 2 Trial#
The earlier phase 2 trial used daily dosing at three dose levels:
- 0.1 mg daily (no significant effect)
- 1 mg daily (significant fecal output reduction)
- 10 mg daily (greatest fecal output reduction)
- Duration: 3 weeks per dose level with 4-8 week washout
Phase 3b Extension#
- 10 mg once weekly for 52 weeks (open-label)
- Demonstrated sustained intestinal absorption improvements
Administration#
Ready-to-Use Autoinjector#
Glepaglutide is the first GLP-2 analog formulated as a ready-to-use liquid for subcutaneous injection via an autoinjector device. This design was specifically enabled by the chemical stability of glepaglutide in aqueous solution, achieved through its nine amino acid substitutions and C-terminal hexalysine tail.
Injection Technique#
- Remove autoinjector from refrigerator and allow to reach room temperature
- Select injection site (abdomen or thigh)
- Rotate injection sites between administrations
- Administer subcutaneously using the autoinjector device
- Maintain consistent 3-4 day intervals between doses
Parenteral Support Adjustment#
As glepaglutide improves intestinal absorption, parenteral support should be reduced gradually under medical supervision:
- Monitor fluid balance, urine output, and serum electrolytes
- Reduce PS volume incrementally based on clinical response
- In the phase 3 trial, PS adjustments were protocol-defined at specific timepoints
- Abrupt PS discontinuation is not recommended even in patients approaching enteral autonomy
Comparison with Teduglutide Dosing#
| Parameter | Glepaglutide | Teduglutide |
|---|---|---|
| Dose | 10 mg | 0.05 mg/kg |
| Frequency | Twice weekly | Daily |
| Formulation | Ready-to-use liquid | Lyophilized powder (requires reconstitution) |
| Device | Autoinjector | Manual syringe |
| Renal impairment | No dose adjustment needed | 50% dose reduction for moderate-severe |
| Annual injections | ~104 | ~365 |
Monitoring Requirements#
- Parenteral support volume: Track weekly to assess treatment response
- Fluid balance: Monitor oral/enteral intake, stool output, and urine output
- Serum electrolytes: Regular monitoring as PS adjustments are made
- Nutritional parameters: Body weight, albumin, and micronutrient levels
- Colonoscopy: Baseline and periodic surveillance for intestinal polyps (recommended for all GLP-2 analogs)
- Stoma output: For patients with jejunostomy or ileostomy
Dosing Context#
Glepaglutide belongs to the Healing category of research peptides. Dosing protocols are derived from clinical trial data and are provided for research reference only. All dosing decisions in SBS should be made by gastroenterologists experienced in intestinal failure management, with careful monitoring of fluid and electrolyte balance.
Related Reading#
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Medical Disclaimer
This website is for educational and informational purposes only. The information provided is not intended to diagnose, treat, cure, or prevent any disease. Always consult with a qualified healthcare professional before using any peptide or supplement.