What company manufactures the neuropathy drug and what is its production history?
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Executive summary
Artelo Biosciences, Inc., a Solana Beach, California biotech, is the company developing the investigational neuropathy drug ART26.12, which originated in research at Stony Brook University and was licensed to Artelo in 2018 [1]. ART26.12 remains in early clinical development—having passed an initial safety review and advanced to higher dosing in a first‑in‑human trial as of January 2025—but there is no public record in the provided reporting of commercial production, large‑scale manufacture, or market release [1].
1. Who makes the drug: a university discovery turned biotech asset
The compound now called ART26.12 was discovered and initially developed by Stony Brook University researchers Iwao Ojima, PhD, and Martin Kaczocha, PhD, and the underlying fatty‑acid binding protein (FABP) inhibitor technology was licensed from the Research Foundation for SUNY to Artelo Biosciences in 2018; Artelo is identified in press reporting as the developer and sponsor of the current clinical program [1].
2. Clinical development, not commercial manufacture
Public reporting shows ART26.12 is an investigational, non‑opioid candidate aimed at chemotherapy‑induced peripheral neuropathy that completed an early safety committee review and was cleared to escalate dosing in its first‑in‑human study in January 2025—an important clinical milestone but not evidence of commercial production or mass manufacturing capacity [1]. The reporting frames ART26.12 as “in clinical development” and highlights preclinical promise and the SRC decision to move to the next dose level, indicating the program remains in the clinical trial phase rather than in production [1].
3. What “production history” exists in the public record: licensing and development milestones
The clearest items in the available reporting about ART26.12’s history are its academic origin, the licensing deal in 2018, and the progression into first‑in‑human trials with safety committee clearance in 2025—these constitute the drug’s documented development history, but they do not include descriptions of batch manufacture, contract manufacturing organizations (CMOs), scale‑up, or commercial supply chains in the sources provided [1]. When a small biotech advances a molecule from university IP into clinical studies, production typically involves GMP batches made for trials through CMOs; however, that specific manufacturing pathway for ART26.12 is not described in the cited press release [1].
4. Broader market context and alternative players
The neuropathic pain field includes both established pharmaceutical firms and small biotechs pursuing non‑opioid options, and analysts project substantial market growth driven by non‑opioid therapeutics and novel mechanisms—context that helps explain why a university‑origin molecule would be licensed to a small company like Artelo [2] [3]. Other firms and technologies are also active: Janssen has marketed tapentadol (NUCYNTA) for diabetic neuropathy, and companies such as Neuropathix/Kannalife and Neuralace Medical are developing different molecular candidates and device therapies for neuropathic conditions, showing the field’s diversity of approaches [4] [5] [6].
5. Limitations in the reporting and what remains unknown
The primary source supplied is a Stony Brook/Artelo‑focused press release that documents discovery, licensing and an early clinical milestone but does not disclose manufacturing partners, GMP batch records, CMO arrangements, or any commercial production dates; therefore, conclusions about who “manufactures” ART26.12 beyond Artelo as the developer, or about its production volumes and factory history, cannot be supported from the provided sources [1]. Independent verification—such as Artelo corporate filings, CMC (chemistry, manufacturing and controls) sections of regulatory submissions, or CMO press releases—would be required to map the molecule’s manufacturing chain and scale‑up history; those documents are not present in the supplied reporting.
6. Implicit incentives and agendas in the reporting
The university press release emphasizes discovery credit, licensing success and clinical progress—an agenda common to academic and biotech communications aimed at promoting technology transfer and attracting investors—so readers should treat the milestone framing as positive news about development rather than evidence of commercial availability or completed manufacturing scale‑up [1]. Market reports cited separately underscore investor interest in non‑opioid neuropathic therapies, which contextualizes why early‑stage firms highlight clinical milestones while details about manufacturing typically follow only after later regulatory steps [2] [3].