Treatment-Resistant Depression (TRD)
Oral esketamine formulation for Treatment-Resistant Depression with potential for home-use administration.
Development Stage — Phase 1 Planning
Overview
SRX-25 is an innovative oral formulation combining esketamine with a CYP-450 inhibitor, designed to treat Treatment-Resistant Depression (TRD). This program represents Nexalis Therapeutics’ expansion into oral drug delivery modalities.
Indication
Treatment-Resistant Depression affects 20–30% of patients with Major Depressive Disorder (MDD) who do not respond adequately to conventional antidepressant treatments.[1] TRD represents a significant unmet medical need with substantial impact on patient quality of life and healthcare costs.
Market Opportunity
The global TRD treatment market was valued at USD 1.95 billion in 2023 and is projected to reach USD 4.06 billion by 2030, growing at a CAGR of 11.0%.[1] Current leading therapies such as Spravato (J&J) have demonstrated significant demand for esketamine therapy, but require clinic-based administration that limits patient access.[2]
Key Milestones Achieved
References
- 1 Fortune Business Insights — Treatment-Resistant Depression Treatment Market. Global TRD market valued at USD 1.95B in 2023, projected to reach USD 4.06B by 2030 (CAGR 11.0%).
- 2 Spravato administration requires 2 hours of monitoring and cannot be taken home, thereby limiting patient access.
- 3 U.S. FDA — Drugs@FDA Database. Regulatory pathway defined by approvals for Symbyax, Spravato, and Auvelity.