SPL-028 is under clinical development by Small Pharma and currently in Phase I for Generalized Anxiety Disorder (GAD). According to GlobalData, Phase I drugs for Generalized Anxiety Disorder (GAD) have an 81% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how SPL-028’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

SPL-028 overview

SPL-028 is under development for the treatment of depression and generalized anxiety disorder . The drug candidate is a deuterium-enriched tryptamine. It is administered through intravenous and intramuscular route. 

Small Pharma overview

Small Pharma is a Canada-based neuroscience company that is focused on discovering and developing novel treatments for mental health conditions, with a focus on depression. The Company makes medicines based on known active ingredients and specializes in IP-led development of treatments for mental health conditions through the development of psychedelic and non-psychedelic medicines. The Company’s dimethyltryptamine (DMT) assisted therapy candidates include SPL028 and SPL026. The Company initiated a clinical program into DMT-assisted therapy, including a Phase I/IIa trial on the Company’s lead candidate alongside development of a robust pipeline of proprietary preclinical assets. The Company seeks to initiate Phase I study of SPL028 with psychotherapy among healthy volunteers to assess safety, tolerability, pharmacodynamics and pharmacokinetics of IM and IV administration. SPL026 is a clinical development program with psychotherapy.It is headquartered in Vancouver, British Columbia, Canada.

For a complete picture of SPL-028’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 7 February 2024

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.