Brimapitide: Dosing Protocols
Dosing guidelines, reconstitution, and administration information
๐TL;DR
- โข1 dosing protocols documented
- โขReconstitution instructions included
- โขStorage: Clinical formulation storage conditions were not publicly disclosed. Clinical supplies were managed under controlled conditions per trial protocols.
Protocol Quick-Reference
Acute idiopathic sudden sensorineural hearing loss (ISSNHL)
Dosing
Amount
0.4-0.8 mg/mL intratympanic gel
Frequency
Single dose
Duration
Single administration (follow-up to 91 days)
Administration
Route
IMTiming
Single intratympanic injection within 72 hours of hearing loss onset. Administered by ENT specialist under local anesthesia. Development discontinued.
Cycle
Duration
Single dose
Repeatable
Single cycle
โ๏ธ Suggested Bloodwork (3 tests)
Audiometric assessment
When: Baseline
Why: Document severity and pattern of hearing loss
Audiometric assessment
When: Day 28
Why: Assess hearing recovery
Audiometric assessment
When: Day 91
Why: Evaluate long-term hearing outcome
๐ก Key Considerations
- โDevelopment discontinued: drug is not available for any clinical use
- โPhase 3 HEALOS trial failed primary endpoint in overall population
- โPost-hoc subgroup analysis showed benefit in profound ISSNHL only (not prospectively confirmed)
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| Purpose | Dose | Frequency | Duration | Notes |
|---|---|---|---|---|
| Acute ISSNHL (Phase 3 HEALOS) | Single intratympanic injection of 0.4 mg/mL or 0.8 mg/mL brimapitide in hyaluronic acid gel. | Single dose | Single administration within 72 hours of hearing loss onset. Follow-up assessments at days 3, 7, 28, and 91. | Development discontinued. The 0.4 mg/mL dose showed the most promising results in the profound hearing loss subgroup. |
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๐Reconstitution Instructions
Brimapitide was supplied as a ready-to-use gel formulation. No reconstitution was required. The hyaluronic acid gel was pre-loaded with the peptide at the specified concentration.
Recommended Injection Sites
- โIntratympanic injection into the middle ear space. The gel was injected through the tympanic membrane under local anesthesia, where it remained in contact with the round window membrane to allow drug diffusion into the inner ear. This is a specialized ENT procedure.
๐งStorage Requirements
Clinical formulation storage conditions were not publicly disclosed. Clinical supplies were managed under controlled conditions per trial protocols.
Community Dosing Protocols
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Before You Begin
Review safety warnings and contraindications before starting any protocol.
Important Notice#
Brimapitide (AM-111) development has been discontinued. This dosing information is provided for educational and historical reference only. The drug is not available for purchase, prescription, or clinical use.
Clinical Trial Dosing#
Phase 3 HEALOS Trial Design#
| Parameter | Details |
|---|---|
| Drug | Brimapitide (AM-111) in hyaluronic acid gel |
| Doses tested | 0.4 mg/mL and 0.8 mg/mL |
| Comparator | Placebo gel |
| Administration | Single intratympanic injection |
| Timing | Within 72 hours of ISSNHL onset |
| Follow-up | Days 3, 7, 28, and 91 |
| Enrollment | 256 patients |
| Study sites | 51 European and Asian sites |
Phase 2 Trial Design#
| Parameter | Details |
|---|---|
| Doses tested | 0.4 mg/mL and 0.8 mg/mL |
| Comparator | Placebo gel |
| Administration | Single intratympanic injection |
| Population | Severe to profound acute sensorineural hearing loss |
Intratympanic Injection Procedure#
The intratympanic injection procedure was performed by an ENT specialist:
- Local anesthesia applied to the tympanic membrane
- Small perforation created in the tympanic membrane (myringotomy) or injection through the membrane
- Brimapitide gel injected into the middle ear space
- Patient positioned to allow gel contact with the round window membrane
- Patient remained supine or with the treated ear facing upward for a period after injection
- The gel gradually released brimapitide across the round window membrane into the cochlea
Dosing Rationale#
The single-dose intratympanic approach was chosen because:
- ISSNHL is an acute event requiring rapid intervention
- The D-amino acid composition provides extended intracellular half-life from a single dose
- Local delivery avoids systemic exposure and potential off-target effects
- The hyaluronic acid gel provides sustained drug release to the inner ear
- The 72-hour treatment window reflects the critical period for cochlear cell rescue
Dosing Context#
Brimapitide belongs to the Healing category of research peptides. Dosing protocols for Brimapitide 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 Brimapitide:
Acute ISSNHL (Phase 3 HEALOS)#
Dose: Single intratympanic injection of 0.4 mg/mL or 0.8 mg/mL brimapitide in hyaluronic acid gel.
Frequency: Single dose
Duration: Single administration within 72 hours of hearing loss onset. Follow-up assessments at days 3, 7, 28, and 91.
Development discontinued. The 0.4 mg/mL dose showed the most promising results in the profound hearing loss subgroup.
Reconstitution and Preparation#
Brimapitide was supplied as a ready-to-use gel formulation. No reconstitution was required. The hyaluronic acid gel was pre-loaded with the peptide at the specified concentration.
Injection Sites#
Recommended injection sites for Brimapitide include:
- Intratympanic injection into the middle ear space. The gel was injected through the tympanic membrane under local anesthesia, where it remained in contact with the round window membrane to allow drug diffusion into the inner ear. This is a specialized ENT procedure.
Site rotation is recommended to minimize local tissue reactions and ensure consistent absorption.
Storage Requirements#
Clinical formulation storage conditions were not publicly disclosed. Clinical supplies were managed under controlled conditions per 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.