CLE-500 is under clinical development by Clexio Biosciences and currently in Phase I for Cluster Headache Syndrome (Cluster Headache). According to GlobalData, Phase I drugs for Cluster Headache Syndrome (Cluster Headache) have a 92% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how CLE-500’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.

CLE-500 overview

CLE-500 is under development for the treatment of cluster headache. It is administered through nasal route. The drug candidate is a patient-controlled drug-device combination. It acts by targeting sphenopalatine ganglion (SPG) nerve pathway.

Clexio Biosciences overview

Clexio Biosciences (Clexio) is a clinical-stage pharmaceutical company focused on the development of novel drugs, small molecules, and drug-device combinations for the treatment pain, depression and other central nervous system (CNS) indications. Its pipeline product portfolio includes CLE-100, an oral NMDA receptor modulator for adjunctive therapy in major depressive disorder; CLE-300, a disruptive platform of wearable drugs; CLE-400, a topical formulation for the treatment of PDN and CLE-500, a patient-controlled drug-device combination for immediate relief of cluster headaches. The company also developed a proprietary oral gastro-retentive drug delivery platform (CLE-600) used for both extending the absorption window and controlled release of multiple pill burdens of numerous drugs. Clexio is headquartered in Jerusalem, Israel.

For a complete picture of CLE-500’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 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.