This section highlights FDA-related milestones and regulatory updates for drugs developed by Artelo Biosciences (ARTL).
Over the past two years, Artelo Biosciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ART12.11, ART26.12, ART27.13, and FABP7. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ART12.11 - FDA Regulatory Timeline and Events
ART12.11 is a drug developed by Artelo Biosciences for the following indication: For overcoming problematic drug properties which allows for precise control over purity, potency, and consistency.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ART12.11
- Announced Date:
- July 7, 2025
- Indication:
- For overcoming problematic drug properties which allows for precise control over purity, potency, and consistency.
Announcement
Artelo Biosciences announced the presentation of compelling new preclinical data on its Cannabidiol (CBD) and Tetramethylpyrazine (TMP) cocrystal drug candidate, ART12.11, at the 35th Annual International Cannabinoid Research Society (ICRS) Symposium, taking place July 6–10 in Bloomington, Indiana.
AI Summary
Artelo Biosciences presented new preclinical data on its patented CBD and tetramethylpyrazine cocrystal drug candidate, ART12.11, at the 35th Annual International Cannabinoid Research Society Symposium in Bloomington, Indiana (July 6–10). The data show that ART12.11 has strong antidepressant-like effects in stressed animal models. In a 28-day study, the drug candidate restored normal behavioral patterns, such as pleasure and social interaction, to levels similar to those seen with the established antidepressant sertraline. Unlike sertraline, ART12.11 also improved spatial and short-term memory, suggesting added benefits for those suffering cognitive issues.
This dual-action profile positions ART12.11 as a promising next-generation treatment for depression, potentially addressing both mood and cognitive challenges in the mental health field.
Read Announcement- Drug:
- ART12.11
- Announced Date:
- July 3, 2024
- Indication:
- For overcoming problematic drug properties which allows for precise control over purity, potency, and consistency.
Announcement
Artelo Biosciences announced several presentations about ART12.11, Artelo's proprietary cocrystal combination drug candidate, were delivered at the 34th Annual International Cannabinoid Research Society (ICRS) Symposium held June 30 through July 5, 2024 in Salamanca, Spain.
AI Summary
At the 34th Annual International Cannabinoid Research Society (ICRS) Symposium in Salamanca, Spain, Artelo Biosciences delivered several presentations focusing on its proprietary cocrystal combination drug candidate, ART12.11. The research showcased ART12.11’s unique pharmacokinetic and pharmacodynamic profiles, with studies highlighting improved bioavailability and increased plasma levels of cannabidiol (CBD) and its metabolites compared to standard CBD formulations. Presentations by Dr. Andrew Yates and Professor Matthew Jones from the University of Western Ontario revealed that oral administration of an aqueous suspension of ART12.11 led to enhanced exposure and similar plasma results as those achieved with an Epidiolex-like formulation under fed conditions in rodent studies. Additionally, preclinical research indicated that ART12.11 significantly reduced anxiety and depressive symptoms in chronically stressed rats in ways that were not observed with CBD or tetramethylpyrazine when given separately or together.
Read Announcement
ART26.12 - FDA Regulatory Timeline and Events
ART26.12 is a drug developed by Artelo Biosciences for the following indication: For the prevention of chemotherapy-induced peripheral neuropathy, a debilitating and often treatment-altering side effect of cancer therapy.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ART26.12
- Announced Date:
- July 9, 2025
- Indication:
- For the prevention of chemotherapy-induced peripheral neuropathy, a debilitating and often treatment-altering side effect of cancer therapy.
Announcement
Artelo Biosciences, announced the presentation of preclinical data in an osteaoarthritis (OA) pain model on its lead fatty acid binding protein 5 (FABP5) inhibitor, ART26.12, at the 35th Annual International Cannabinoid Research Society (ICRS) Symposium, being held July 6–10 in Bloomington, Indiana.
AI Summary
Artelo Biosciences presented new preclinical data at the 35th Annual International Cannabinoid Research Society (ICRS) Symposium in Bloomington, Indiana. The data focused on its lead FABP5 inhibitor, ART26.12, which aims to treat osteoarthritis (OA) pain. The study, led by Dr. Martin Kaczocha of Stony Brook University, showed that ART26.12 significantly reduced OA pain in animal models. The research revealed that daily treatment with ART26.12 increased plasma levels of endocannabinoids such as 2-Arachidonoylglycerol (2-AG) and Oleoylethanolamide (OEA), which were closely linked to improved weight-bearing capacity on the affected joint. Furthermore, ART26.12 maintained its pain-relieving effects over four weeks, performing comparably to naproxen but without the tolerance issues commonly seen with chronic treatments. These promising results suggest that ART26.12 may offer a safer, long-term alternative to traditional NSAIDs for managing osteoarthritis pain.
Read Announcement- Drug:
- ART26.12
- Announced Date:
- June 30, 2025
- Indication:
- For the prevention of chemotherapy-induced peripheral neuropathy, a debilitating and often treatment-altering side effect of cancer therapy.
Announcement
Artelo Biosciences, announced favorable results from its first-in-human study evaluating ART26.12, a novel inhibitor of Fatty Acid Binding Protein 5 (FABP5).
AI Summary
Artelo Biosciences recently announced positive results from its first-in-human study evaluating ART26.12, their novel inhibitor of Fatty Acid Binding Protein 5 (FABP5). This Phase 1 study involved 49 healthy volunteers who received a single ascending dose. The trial showed that ART26.12 is safe and well-tolerated, with only mild and temporary side effects. No serious or drug-related adverse events were observed, which supports the drug’s robust safety profile. Additionally, the study confirmed predictable, dose-dependent absorption, highlighting a wide therapeutic window between effective doses and higher exposure levels.
These encouraging findings mark ART26.12 as a promising, first-in-class candidate for non-opioid pain management. With its unique mechanism that could modulate lipid signaling to produce analgesic effects, ART26.12 may offer a new treatment option for patients seeking safer alternatives in pain management.
Read Announcement- Drug:
- ART26.12
- Announced Date:
- April 28, 2025
- Indication:
- For the prevention of chemotherapy-induced peripheral neuropathy, a debilitating and often treatment-altering side effect of cancer therapy.
Announcement
EXCLUSIVE: Artelo Biosciences Tells Benzinga Co. Announces Publication Of New Peer-Reviewing Research Demonstrating ART26.12's Effectiveness In Treating Psoriasis
AI Summary
Artelo Biosciences recently announced an exclusive update to Benzinga regarding new peer-reviewed research published in the Journal of Investigative Dermatology. The study shows that ART26.12, the company’s orally active small-molecule inhibitor of Fatty Acid Binding Protein 5 (FABP5), effectively treats psoriasis. In both laboratory (in vitro) and animal (in vivo) models, ART26.12 demonstrated results comparable to powerful immunomodulatory drugs, while potentially avoiding some of their serious side effects.
Lead scientist Dr. George Warren highlighted that the research findings support FABP5 as a promising target for psoriasis treatment. The study suggests that inhibiting FABP5, which is overexpressed in psoriasis, could reduce inflammation and abnormal skin cell growth. This new data presents ART26.12 as a potentially safer, more cost-effective option for managing psoriasis, offering hope for patients in need of alternative therapies.
Read Announcement- Drug:
- ART26.12
- Announced Date:
- January 13, 2025
- Indication:
- For the prevention of chemotherapy-induced peripheral neuropathy, a debilitating and often treatment-altering side effect of cancer therapy.
Announcement
Artelo Biosciences, announced the completed safety review of the first cohort of eight healthy volunteers in the Company's Phase 1 study of ART26.12.
AI Summary
Artelo Biosciences recently announced a key milestone in its clinical development program. The company completed the safety review for the first cohort of eight healthy volunteers in its Phase 1 study of ART26.12. This study is focused on ART26.12, the first-ever selective Fatty Acid Binding Protein 5 (FABP5) inhibitor to be tested in humans. The review confirmed that the drug was safely administered, paving the way for progression into the next cohort of participants. Researchers plan to use the findings from this phase to determine safe dosing levels for future studies. ART26.12 is being developed as a non-opioid, non-steroidal treatment option with potential benefits in managing various pain conditions. The ongoing study will assess safety, pharmacokinetics, and biomarkers, with initial data expected in the first half of 2025.
Read Announcement- Drug:
- ART26.12
- Announced Date:
- July 15, 2024
- Estimated Event Date Range:
- January 1, 2025 - June 30, 2025
- Target Action Date:
- H1 2025
- Indication:
- For the prevention of chemotherapy-induced peripheral neuropathy, a debilitating and often treatment-altering side effect of cancer therapy.
Announcement
Artelo Biosciences announced that Phase 1 trial results expected in the first half of 2025,
AI Summary
Artelo Biosciences announced that its Phase 1 trial for ART26.12 is set to begin soon, with initial results expected in the first half of 2025. ART26.12 is aimed at treating painful neuropathies, including chemotherapy-induced peripheral neuropathy (CIPN), for which there are currently no FDA-approved treatments. This compound, the first selective FABP5 inhibitor from their proprietary Fatty Acid Binding Protein (FABP) platform, represents a promising non-opioid approach to pain management in cancer patients.
The upcoming Phase 1 single ascending dose study will mark the first time ART26.12 is tested in humans. Artelo Biosciences has already initiated study startup activities in collaboration with Worldwide Clinical Trials, an internationally recognized contract research organization, to ensure the trial is carried out with high standards. The company is optimistic that the trial results will confirm ART26.12’s potential in addressing a significant unmet medical need.
Read Announcement- Drug:
- ART26.12
- Announced Date:
- July 15, 2024
- Indication:
- For the prevention of chemotherapy-induced peripheral neuropathy, a debilitating and often treatment-altering side effect of cancer therapy.
Announcement
Artelo Biosciences, announced that the U.S. Food and Drug Administration (FDA) has issued a "Study May Proceed" letter for the Company's Investigational New Drug (IND) application for ART26.12, for the treatment of chemotherapy-induced peripheral neuropathy (CIPN).
AI Summary
Artelo Biosciences announced that the FDA has issued a "Study May Proceed" letter for its Investigational New Drug (IND) application for ART26.12, aimed at treating chemotherapy-induced peripheral neuropathy (CIPN). This clearance allows the company to start its first-in-human Phase 1 single ascending dose study, with results expected in early 2025. ART26.12 is the first selective FABP5 inhibitor emerging from Artelo’s proprietary Fatty Acid Binding Protein platform, which targets lipid signaling pathways. The treatment offers a potential non-opioid option for managing painful neuropathies, addressing a significant unmet medical need since there is currently no FDA-approved therapy for CIPN. Study startup activities are already underway in collaboration with Worldwide Clinical Trials, marking a promising advance in drug development for CIPN patients.
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ART27.13 (CAReS) - FDA Regulatory Timeline and Events
ART27.13 (CAReS) is a drug developed by Artelo Biosciences for the following indication: Cancer anorexia and Weight loss.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ART27.13 (CAReS)
- Announced Date:
- December 9, 2024
- Indication:
- Cancer anorexia and Weight loss
Announcement
Artelo Biosciences, announced the presentation of preliminary data on ART27.13, the Company's benzimidazole derivative, being studied for cancer-related anorexia.
AI Summary
Artelo Biosciences recently presented promising preliminary data on ART27.13, a benzimidazole derivative tested for cancer-related anorexia. The data was shared at the 17th International Conference on Sarcopenia, Cachexia, & Wasting Disorders, and comes from the Cancer Appetite Recovery Study (CAReS). In this Phase 1/2 trial, doses ranging from 150 to 650 micrograms were given to cancer patients experiencing weight loss. The drug was well tolerated, with only a few mild to moderate side effects and no serious adverse events. Notably, about two-thirds of the patients showed signs of weight stabilization or a reversal of weight loss after one month of treatment. These encouraging results support further evaluation of ART27.13, as the Phase 2 stage of the study is currently enrolling participants to better understand its potential to improve appetite, body weight, and overall quality of life in cancer patients.
Read Announcement
FABP7 - FDA Regulatory Timeline and Events
FABP7 is a drug developed by Artelo Biosciences for the following indication: Promising Novel Target in Cancer Therapy.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- FABP7
- Announced Date:
- April 23, 2024
- Indication:
- Promising Novel Target in Cancer Therapy
Announcement
Artelo Biosciences, announced the publication of an article, "The emerging role of fatty acid binding protein 7 (FABP7) in cancers," in Drug Discovery Today, a peer-reviewed journal.
AI Summary
Artelo Biosciences recently published an article in the peer-reviewed journal Drug Discovery Today titled “The emerging role of fatty acid binding protein 7 (FABP7) in cancers.” The article discusses the role of FABP7, a protein that helps transport and store fats in cells, in various types of cancer such as breast, brain, and kidney cancers. Studies highlighted in the article show that high levels of FABP7 are often linked to poorer patient outcomes. Researchers also found that both genetic and pharmacological methods to block FABP7 can reduce tumor growth, cell migration, and invasion. These findings suggest that targeting FABP7 could be a promising new approach in treating cancer. The article underlines the importance of further research on FABP inhibitors and supports Artelo Biosciences’ commitment to developing innovative therapies for cancer and other serious conditions.
Read Announcement
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