Rapastinel: Risks & Legal Status

Critical Safety Information#

Rapastinel (GLYX-13) is a discontinued investigational drug that failed phase 3 clinical trials. It is not approved for any therapeutic use. Despite a favorable acute safety profile, its discontinued status and IV administration requirement present significant considerations.

Primary Risks#

Discontinued Development#

All three phase 3 trials failed, meaning rapastinel has not demonstrated efficacy in adequately powered studies.

IV Administration#

Intravenous infusion carries inherent risks including infection, infiltration, and the requirement for clinical supervision.

Limited Safety Database#

Approximately 430 subjects were exposed across clinical trials with no long-term follow-up data.

Legal and Regulatory Status#

Rapastinel is not a controlled substance. It is available only as a research chemical.

Risk Assessment Context#

Rapastinel belongs to the Neuropeptide category of research peptides. Risk assessment for Rapastinel should consider both the compound-specific risks identified in clinical research and the broader regulatory environment. Researchers and healthcare providers should evaluate these risks in the context of the specific patient population and therapeutic indication.

Risk Categories#

The following risk categories have been identified for Rapastinel based on available evidence and regulatory assessments:

Discontinued Clinical Development#

Rapastinel failed three phase 3 clinical trials in March 2019 and development was discontinued by Allergan. Not approved for any use.

IV Administration Required#

Requires intravenous infusion in a clinical setting, presenting practical limitations and risks for unsupervised use.

Limited Long-Term Safety Data#

Only approximately 430 subjects exposed across clinical trials. No long-term safety follow-up data available.

Regulatory Status by Jurisdiction#

The regulatory and legal status of Rapastinel varies by country and jurisdiction. Researchers should verify current regulations before acquiring or using this compound.

Regulatory classifications can change. Researchers are responsible for complying with all applicable laws and regulations in their jurisdiction.

Important Warnings#

The following warnings apply to Rapastinel:

• DISCONTINUED DRUG: Rapastinel failed phase 3 clinical trials and is not approved for any therapeutic use.
• IV ADMINISTRATION REQUIRED: Must be administered intravenously in appropriate clinical settings with proper monitoring.
• LIMITED SAFETY DATA: Safety database limited to approximately 430 subjects with no long-term follow-up.

These warnings are based on available preclinical and clinical data. The absence of a warning does not indicate safety. Consult qualified professionals before making any decisions regarding peptide research.

Related Reading#

• Rapastinel overview and research guide
• Rapastinel side effects profile
• Rapastinel research evidence