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
ART27.13, ART26.12, and ART12.11. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
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:
- July 13, 2026
- Indication:
- Cancer anorexia and Weight loss
Announcement
Artelo Biosciences, announced promising results from nonclinical studies in neuropathic pain with ART27.13, the Company's proprietary peripherally restricted cannabinoid receptor agonist, currently in Phase 2 clinical development evaluating patients experiencing cancer-related anorexia cachexia syndrome (CACS).
AI Summary
Artelo Biosciences said its drug candidate ART27.13 may have wider use in cancer supportive care after promising nonclinical results in neuropathic pain. In a study using a paclitaxel-induced peripheral neuropathy model, repeated doses of ART27.13 reduced pain-related behaviors such as mechanical allodynia and thermal hyperalgesia in both male and female animals. This is important because paclitaxel can cause painful nerve damage in many cancer patients.
ART27.13 is a peripherally restricted cannabinoid receptor agonist now in Phase 2 testing for cancer-related anorexia-cachexia syndrome (CACS), a condition marked by weight loss and muscle loss. The company said these findings build on earlier CAReS trial results, which showed improvements in body weight, lean body mass, and activity levels. Artelo believes the drug could help address multiple symptoms that affect cancer patients’ quality of life.
Read Announcement- Drug:
- ART27.13 (CAReS)
- Announced Date:
- September 29, 2025
- Indication:
- Cancer anorexia and Weight loss
Announcement
Artelo Biosciences, announced the first public presentation of the interim data from its Phase 2 Cancer Appetite Recovery Study (CAReS) evaluating ART27.13 in patients with cancer anorexia-cachexia syndrome (CACS).
AI Summary
Artelo Biosciences announced the first public presentation of interim data from its Phase 2 Cancer Appetite Recovery Study (CAReS), evaluating ART27.13 in patients with cancer anorexia-cachexia syndrome (CACS). The data were shared by Professor Barry Laird at the 8th Cancer Cachexia Society Conference in Turin, Italy. This study explores whether ART27.13, a novel oral therapy, can help cancer patients regain weight, preserve muscle, and increase daily activity.
Interim results showed that patients titrated to the highest ART27.13 dose (1,300 µg) achieved an average 6% weight gain over 12 weeks, while placebo patients lost about 5%. Lean body mass improved in line with total weight gain. Digital wearable devices revealed higher frequency and intensity of daily activity in treated patients compared to placebo. ART27.13 maintained a favorable safety profile, with mostly mild to moderate adverse events and no serious drug-related issues.
These findings underline ART27.13’s potential to meaningfully improve physical outcomes and quality of life for cancer patients suffering from CACS. Artelo plans to advance development and explore partnerships to bring this therapy to those in critical need.
Read Announcement- Drug:
- ART27.13 (CAReS)
- Announced Date:
- September 3, 2025
- Indication:
- Cancer anorexia and Weight loss
Announcement
Artelo Biosciences, announced highly encouraging interim results from its Phase 2 Cancer Appetite Recovery Study (CAReS) trial with ART27.13, the Company's peripherally acting cannabinoid receptor agonist for the treatment of cancer anorexia-cachexia syndrome (CACS).
AI Summary
Artelo Biosciences announced encouraging interim results from its Phase 2 Cancer Appetite Recovery Study (CAReS) of ART27.13, a peripherally acting cannabinoid receptor agonist for cancer anorexia-cachexia syndrome (CACS). After 12 weeks at the 1300 μg dose, patients gained an average of 6.4% body weight compared to a 5.4% weight loss on placebo. Lean body mass rose 4.2% after one month in the treatment group versus a 3.2% loss in the placebo arm. Participants also showed improvements in daily activity scores, including moderate and vigorous movements measured by wearable monitors.
Safety results were consistent with Phase 1 findings, with mostly mild or moderate side effects and no new safety signals. As CACS affects up to 80% of people with advanced cancer and lacks any approved therapy, these data support rapid partnering discussions and potential advancement of ART27.13 toward regulatory approval.
Read Announcement- 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
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 1, 2026
- Indication:
- For the prevention of chemotherapy-induced peripheral neuropathy, a debilitating and often treatment-altering side effect of cancer therapy.
Announcement
Artelo Biosciences, announced positive new data from a preclinical study in neuropathic pain from spinal cord injury.
AI Summary
Artelo Biosciences reported positive new preclinical results for ART26.12 in neuropathic pain caused by spinal cord injury. The study, done at Stony Brook University, used a mouse model that closely matches this type of nerve pain in people. Researchers found that selective FABP5 inhibition reduced mechanical hypersensitivity, lowered spontaneous pain-related behaviors, and reduced overactive nerve cell activity. The treatment also improved pain outcomes when given by mouth. These findings are important because neuropathic pain after spinal cord injury is common and often difficult to treat with current therapies. The new data suggest ART26.12 may offer a promising new approach for managing this severe and long-lasting pain condition. Artelo said the results support further development of the drug candidate.
Read Announcement- Drug:
- ART26.12
- Announced Date:
- June 29, 2026
- Indication:
- For the prevention of chemotherapy-induced peripheral neuropathy, a debilitating and often treatment-altering side effect of cancer therapy.
Announcement
Artelo Biosciences, announced two presentations of clinical and translational research findings supporting the development of ART26.12, the Company's proprietary selective fatty acid binding protein 5 (FABP5) inhibitor, at the International Cannabinoid Research Society (ICRS) 2026 Annual Symposium.
AI Summary
Artelo Biosciences announced two presentations at the International Cannabinoid Research Society 2026 Annual Symposium highlighting new clinical and translational research on ART26.12, its selective FABP5 inhibitor. The first study reported results from first-in-human testing, showing a favorable safety and tolerability profile, linear dose-dependent pharmacokinetics, and dose-proportional exposure. Researchers also found ART26.12 reached plasma levels above those expected to be effective based on earlier preclinical studies, with a wide margin between likely therapeutic doses and the highest tolerated doses.
The second presentation focused on possible biomarkers of target engagement. Scientists identified changes in the plasma proteome and lipidome after ART26.12 dosing, which may help confirm FABP5 inhibition and measure early signs of activity. Artelo said these findings support continued development of ART26.12 as a non-opioid treatment for painful neuropathies and other conditions where better options are needed.
Read Announcement- Drug:
- ART26.12
- Announced Date:
- April 20, 2026
- 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 publication of a peer‑reviewed article titled "Evaluating fatty acid-binding protein 5 (FABP5) as a therapeutic target for pain management" in the European Journal of Pain, an internationally recognized journal in pain research.
AI Summary
Artelo Biosciences announced a peer‑reviewed article, "Evaluating fatty acid‑binding protein 5 (FABP5) as a therapeutic target for pain management," published in the European Journal of Pain. The paper reports preclinical evidence that inhibiting FABP5 produced analgesic effects across multiple pain models—visceral, inflammatory, neuropathic, and joint pain. It also shows FABP5 inhibition can affect established pain pathways and lower pro‑inflammatory mediators, supporting a differentiated, non‑opioid approach to treating pain.
The article highlights data specific to Artelo’s lead candidate, ART26.12, which showed consistent analgesic activity in seven preclinical studies covering diabetic neuropathy, osteoarthritis, cancer bone pain, and chemotherapy‑induced peripheral neuropathy. A Phase 1 single‑ascending‑dose study reported excellent safety with no adverse events attributed to ART26.12. Artelo plans a multiple ascending dose study this year to advance development. "Preclinical data across multiple pain modalities strongly support FABP5 as a promising target," said Dr. William George Warren, lead author and Artelo principal scientist.
Read Announcement- Drug:
- ART26.12
- Announced Date:
- February 24, 2026
- Indication:
- For the prevention of chemotherapy-induced peripheral neuropathy, a debilitating and often treatment-altering side effect of cancer therapy.
Announcement
Artelo Biosciences, Inc today provided a business update and announced its financial and operational results for the fiscal year ended December 31, 2025.
AI Summary
Artelo Biosciences provided a business update and announced financial and operational results for the fiscal year ended December 31, 2025, highlighting clinical and regulatory progress across its pipeline.
The company reported a successful Phase 1 single ascending dose study of ART26.12 with a favorable safety profile, predictable pharmacokinetics, and dosing flexibility. Artelo plans to begin a multiple ascending dose study in Q3 2026. Preclinical data showed sustained analgesic effects without tolerance, comparable to naproxen, supporting ART26.12 as a potential non‑opioid, non‑steroidal pain treatment.
Artelo also announced positive interim Phase 2 CAReS data for ART27.13, showing improvements in body weight, lean body mass, and physical activity versus placebo with a favorable side‑effect profile. The European Patent Office issued a Notice of Allowance extending protection to December 2041. Favorable MHRA guidance for ART12.11 could streamline development, and human oral studies are planned for H1 2027 pending toxicology results.
Read Announcement- Drug:
- ART26.12
- Announced Date:
- October 15, 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 Professor Saoirse O'Sullivan, Vice President of Translational Sciences at Artelo Biosciences, is presenting expanded data from Artelo's lead Fatty Acid Binding Protein 5 (FABP5) inhibitor, ART26.12, Single Ascending Dose (SAD) Study at the 8th Annual Cannabinoid & Endocannabinoid Drug Development Summit, taking place October 15–16, 2025, in Boston, Massachusetts.
AI Summary
Artelo Biosciences announced that Professor Saoirse O’Sullivan, Vice President of Translational Sciences, will present expanded data from its lead Fatty Acid Binding Protein 5 (FABP5) inhibitor, ART26.12, at the 8th Annual Cannabinoid & Endocannabinoid Drug Development Summit on October 15–16, 2025, in Boston, Massachusetts.
The Single Ascending Dose (SAD) study in healthy volunteers evaluated safety, tolerability and pharmacokinetics of ART26.12 up to a single 1,050 mg dose. Results showed no safety concerns and demonstrated predictable, linear plasma exposure across all dose levels.
In a preliminary food effect investigation, ART26.12 displayed consistent exposure whether given in fed or fasted conditions, suggesting dosing flexibility for future trials.
These positive findings support advancing ART26.12 into multiple ascending dose studies and proof-of-principle pain trials, with potential as a non-opioid treatment for chemotherapy-induced neuropathy.
Read Announcement- Drug:
- ART26.12
- Announced Date:
- August 25, 2025
- Indication:
- For the prevention of chemotherapy-induced peripheral neuropathy, a debilitating and often treatment-altering side effect of cancer therapy.
Announcement
Artelo Biosciences, Inc. announced encouraging results from its preliminary food effect evaluation with ART26.12.
AI Summary
Artelo Biosciences reported encouraging results from its preliminary food effect evaluation with ART26.12. This assessment was part of the successful single ascending dose (SAD) Phase 1 trial. The study tested ART26.12 in healthy volunteers under fed and fasted conditions.
Key findings include a favorable safety profile with no serious adverse events. All side effects were mild and matched those in the SAD trial. Pharmacokinetic data showed consistent drug levels in fasted participants and low variability among subjects. Plasma measurements suggest ART26.12 can be taken with or without food.
These results support moving forward to a multiple ascending dose study planned for later this year. The findings give confidence that future trials can dose ART26.12 in either fed or fasted states, helping advance this nonopioid pain treatment toward clinical use.
Read Announcement- 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
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:
- September 10, 2025
- Indication:
- For overcoming problematic drug properties which allows for precise control over purity, potency, and consistency.
Announcement
Artelo Biosciences, announced the publication of new preclinical data on ART12.11, its proprietary cannabidiol:tetramethylpyrazine (CBD:TMP) cocrystal.
AI Summary
Artelo Biosciences announced the publication of new preclinical data on ART12.11, its proprietary cannabidiol:tetramethylpyrazine (CBD:TMP) cocrystal, in the journal Progress in Neuro-Psychopharmacology and Biological Psychiatry. The study, done with researchers at Western Ontario University, showed that ART12.11 performed better than CBD alone, TMP alone, or a simple mixture of both compounds in a stress-induced model of depression and anxiety.
Key findings included strong anti-depressant and anxiolytic-like effects, higher oral bioavailability of CBD and its main metabolite, and greater activation of endocannabinoid and serotonergic systems in brain areas tied to mood regulation. These results suggest ART12.11 offers more consistent pharmacokinetics and stronger therapeutic benefits than traditional CBD formulations.
By overcoming the limits of conventional CBD—such as poor absorption and variable efficacy—ART12.11 may become a leading treatment for mood and anxiety disorders. Artelo believes this cocrystal’s improved properties could translate into safer, more effective cannabinoid-based medicines for patients.
Read Announcement- Drug:
- ART12.11
- Announced Date:
- August 1, 2025
- Indication:
- For overcoming problematic drug properties which allows for precise control over purity, potency, and consistency.
Announcement
Artelo Biosciences, announced that it has received written scientific advice from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) on the nonclinical development and first-in-human (FIH) clinical study plans for ART12.11, a novel cocrystal of Cannabidiol (CBD) and Tetramethylpyrazine (TMP).
AI Summary
Artelo Biosciences announced it received scientific advice from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on nonclinical development and first-in-human plans for ART12.11, a novel cocrystal combining cannabidiol (CBD) and tetramethylpyrazine (TMP). The MHRA agreed that existing CBD and TMP data could streamline the trial application process. They provided guidance on completing the data package for a single-dose, multi-formulation crossover study to define ART12.11’s pharmacokinetics.
The agency also suggested ART12.11 might qualify for the Innovative Licensing and Access Pathway (ILAP), which can speed up development through early collaboration with regulators and health services. Artelo plans to consider applying to ILAP soon.
Artelo said the MHRA’s feedback will lower costs and help them enter clinical trials early next year. Earlier studies found ART12.11 had better pharmacokinetics and efficacy than CBD alone. They believe ART12.11’s novel design could improve treatment options for anxiety and depression.
Read Announcement- 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
