Risuteganib: Dosing Protocols
Dosing guidelines, reconstitution, and administration information
๐TL;DR
- โข2 dosing protocols documented
- โขReconstitution instructions included
- โขStorage: Storage conditions for the clinical formulation have not been publicly disclosed. Clinical supplies are managed under controlled conditions per clinical trial protocols.
Protocol Quick-Reference
Treatment of intermediate dry age-related macular degeneration
Dosing
Amount
1.0 mg intravitreal injection
Frequency
Every 12 weeks (Phase 2b/3 design)
Duration
52 weeks (Phase 2b/3 primary endpoint)
Administration
Route
IVSchedule
Every 12 weeks
Timing
Intravitreal injection administered by a qualified retinal specialist under sterile ophthalmic conditions. Not a subcutaneous or systemic injection.
Cycle
Duration
52 weeks
Repeatable
Yes
โ๏ธ Suggested Bloodwork (3 tests)
Best corrected visual acuity (BCVA)
When: Baseline and every 12 weeks
Why: Primary efficacy endpoint for visual function
Intraocular pressure (IOP)
When: Post-injection
Why: Monitor for elevated IOP after intravitreal injection
Optical coherence tomography (OCT)
When: Baseline and periodic
Why: Monitor retinal structure and integrity
๐ก Key Considerations
- โInvestigational drug not approved by any regulatory agency; administered only in clinical trial settings
- โIntravitreal injections carry inherent procedural risks including endophthalmitis and retinal detachment
- โPhase 2a results are promising but Phase 2b/3 confirmation trials are ongoing
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| Purpose | Dose | Frequency | Duration | Notes |
|---|---|---|---|---|
| Intermediate Dry AMD (Phase 2a) | 1.0 mg intravitreal injection. Two injections total in the Phase 2a trial, separated by 16 weeks. | Every 16 weeks (Phase 2a design) | 28-week study period with two doses administered at baseline and week 16. | Investigational dosing. Phase 2b/3 design uses 5 intravitreal injections 12 weeks apart with continued treatment during follow-up. |
| Intermediate Dry AMD (Phase 2b/3 Design) | 1.0 mg intravitreal injection. | Every 12 weeks | 5 intravitreal injections 12 weeks apart, with continued treatment during the follow-up safety period. Primary endpoint assessed at 52 weeks. | FDA Special Protocol Assessment agreement received for this trial design. Study ongoing. |
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๐Reconstitution Instructions
Risuteganib is supplied as a sterile solution for intravitreal injection. No reconstitution is required. It is administered as a ready-to-use formulation by a qualified ophthalmologist.
Recommended Injection Sites
- โIntravitreal injection only. Administered into the vitreous cavity of the eye by a qualified retinal specialist under sterile conditions. This is not a subcutaneous, intramuscular, or intravenous injection.
๐งStorage Requirements
Storage conditions for the clinical formulation have not been publicly disclosed. Clinical supplies are managed under controlled conditions per clinical trial protocols.
Community Dosing Protocols
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Before You Begin
Review safety warnings and contraindications before starting any protocol.
Important Notice#
Risuteganib is an investigational drug administered only in clinical trial settings by qualified retinal specialists. It is not available for purchase or prescription. The dosing information below reflects clinical trial protocols only.
Intravitreal Injection#
Risuteganib is administered by intravitreal injection, a procedure performed by a retinal specialist in a clinical setting. This involves injecting a small volume of drug solution directly into the vitreous cavity of the eye.
Phase 2a Dosing Protocol#
| Parameter | Details |
|---|---|
| Dose | 1.0 mg risuteganib |
| Route | Intravitreal injection |
| Schedule | Baseline injection, second injection at week 16 |
| Study duration | 28 weeks |
| Comparator | Sham injection |
| Crossover | Sham group crossed over to risuteganib at week 16 |
Phase 2b/3 Dosing Protocol (FDA SPA)#
| Parameter | Details |
|---|---|
| Dose | 1.0 mg risuteganib |
| Route | Intravitreal injection |
| Schedule | 5 injections, 12 weeks apart |
| Primary endpoint | BCVA improvement at 52 weeks |
| Comparator | Sham injection |
| Follow-up | Continued treatment during safety follow-up period |
Injection Procedure#
Intravitreal injection of risuteganib follows standard ophthalmic procedures:
- Topical anesthesia applied to the eye
- Povidone-iodine antiseptic preparation
- Speculum placed to hold the eye open
- Injection through the pars plana (3.5-4.0 mm from the limbus)
- Post-injection monitoring for elevated intraocular pressure
- Follow-up assessment per clinical trial protocol
Dosing Rationale#
The 1.0 mg dose was selected based on Phase 1 dose-escalation studies. The 12-week dosing interval in the Phase 2b/3 trial is supported by the retinal half-life of approximately 21 days, which allows for sustained drug exposure between injections. This dosing interval compares favorably with many intravitreal anti-VEGF agents that require monthly or bimonthly injections.
Dosing Context#
Risuteganib belongs to the Healing category of research peptides. Dosing protocols for Risuteganib are derived from available clinical trial data. These protocols are provided for research reference only and do not constitute medical advice. Actual dosing decisions should be made by qualified healthcare providers based on individual patient factors.
Research Protocols#
The following dosing protocols have been documented in clinical research for Risuteganib:
Intermediate Dry AMD (Phase 2a)#
Dose: 1.0 mg intravitreal injection. Two injections total in the Phase 2a trial, separated by 16 weeks.
Frequency: Every 16 weeks (Phase 2a design)
Duration: 28-week study period with two doses administered at baseline and week 16.
Investigational dosing. Phase 2b/3 design uses 5 intravitreal injections 12 weeks apart with continued treatment during follow-up.
Intermediate Dry AMD (Phase 2b/3 Design)#
Dose: 1.0 mg intravitreal injection.
Frequency: Every 12 weeks
Duration: 5 intravitreal injections 12 weeks apart, with continued treatment during the follow-up safety period. Primary endpoint assessed at 52 weeks.
FDA Special Protocol Assessment agreement received for this trial design. Study ongoing.
Reconstitution and Preparation#
Risuteganib is supplied as a sterile solution for intravitreal injection. No reconstitution is required. It is administered as a ready-to-use formulation by a qualified ophthalmologist.
Injection Sites#
Recommended injection sites for Risuteganib include:
- Intravitreal injection only. Administered into the vitreous cavity of the eye by a qualified retinal specialist under sterile conditions. This is not a subcutaneous, intramuscular, or intravenous injection.
Site rotation is recommended to minimize local tissue reactions and ensure consistent absorption.
Storage Requirements#
Storage conditions for the clinical formulation have not been publicly disclosed. Clinical supplies are managed under controlled conditions per clinical trial protocols.
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.