A Phase I, Open Label, Study of 3,4-Methylenedioxymethamphetamine (MDMA) Tolerability and Pharmacokinetics in Subjects With Moderate Hepatic Impairment Compared to Matched Control Subjects With Normal Hepatic Function

The goal of this clinical trial to learn how MDMA is processed in people with abnormal liver function.
The main questions it aims to answer are:
Do people with abnormal liver function experience greater absorption of MDMA? Does the dose of MDMA need to be adjusted in people with abnormal liver function?
Researchers will compare people with abnormal liver function to people with normal liver function.
Participants will receive a single dose of MDMA then undergo periodic vitals measurements. They will remain at the study site for two more days undergoing more vitals measurements and having subjective effects and adverse events measured.

Start Date29 Mar 2026

Sponsor / Collaborator

Lykos Therapeutics, Inc.Startup

NCT04454684

/ WithdrawnPhase 2

An Open-Label, Multi-Site Phase 2 Study of the Safety and Feasibility of MDMA-Assisted Psychotherapy for Eating Disorders

The goal of this clinical trial is to learn if MDMA-assisted therapy and caregiver involvement are safe and effective in treating female participants with eating disorders.
The main question it aims to answer is: Does MDMA-assisted therapy reduce eating disorder symptoms?
Participants will undergo two non-drug preparatory therapy sessions and their caregiver will undergo one non-drug preparatory therapy session. Participants will undergo three sessions of MDMA-assisted therapy followed by non-drug integrative therapy sessions alone as well as together with their caregiver.

Start Date01 Feb 2026

Sponsor / Collaborator

Lykos Therapeutics, Inc.Startup

NCT06353282

/ WithdrawnPhase 2IIT

3, 4-methylenedioxymethamphetamine (MDMA) for Treatment-resistant Post-traumatic Stress Disorder (PTSD) in Adolescents

The primary objective of this study is to determine the safety and feasibility of 3,4-methylenedioxymethamphetamine (MDMA) -assisted psychotherapy to treat resistant post-traumatic stress disorder (PTSD). The secondary objectives are the exploration of effectiveness for treatment-resistant PTSD, symptoms of depression, and anxiety symptoms.

Start Date01 Jul 2025

Sponsor / Collaborator

University of California, Los Angeles

100 Clinical Results associated with Methylenedioxymetamfetamine

100 Translational Medicine associated with Methylenedioxymetamfetamine

100 Patents (Medical) associated with Methylenedioxymetamfetamine

9,556

Literatures (Medical) associated with Methylenedioxymetamfetamine

01 Oct 2025·TALANTA

Screening and validation of sponge materials assembled to a sampling device for enrichment and determination of amphetamine drugs in exhaled breath by HPLC-TQ-MS/MS

Article

Author: Yang, Xiangliang ; Fan, Huajun ; Xu, Fei ; Huang, Qingda ; Xu, Congfei ; Yang, Hai ; Zhou, Jiedan

Exhaled breath aerosol (EBA) analysis of the amphetamine drugs (AMPs) and ephedrine (EPH) has a great potential to monitor illicit drug abuse due to its simple, non-invasive, convenient, and easily accepted sampling. Nevertheless, the extremely low concentration of AMPs and EPH in EBA poses great challenges to instrumental analysis. In this study, a self-designed sampling device equipped with sponge-based material was developed and coupled to high-performance liquid chromatography coupled with triple quadrupole tandem mass spectrometry (HPLC-TQ-MS/MS) for monitoring of the AMPs and EPH in EBA. Accordingly, the cellulose sponge with high adsorption performance and low expiratory resistance was screened out from multiple commercial sponges, optimized its configuration performance, and assembled to the sampling device, reaching the adsorption rates of 81.6 ± 2.2-98.9 ± 2.5 % for EPH and typical AMPs, including amphetamine, methamphetamine, 3,4-methylenedioxyamphetamine, and 3,4-methylenedioxymethamphetamine. The combination of HPLC-TQ-MS/MS and the device containing cellulose sponge showed excellent analytical performance, with linearity in the range of 30.0-20000.0 pg/filter (R² ≥ 0.9901), low detection limit of 1.6-8.4 pg/filter, and the recoveries of 86.5-94.5 %. The device also exhibited good reusability and applicability for the simulated EBAs at different levels. Furthermore, the proposed method was successfully applied for determination of EPH in volunteers' EBAs, whose contents suggested a good correlation with that in saliva. Kinetic analysis provided insights into the adsorption mechanism, further validating reliability of the method. Overall, the simple, cheap, available, and reusable cellulose sponge assembled to sampling device was advantageous for enriching and monitoring of trace illicit drugs in human EBA.

01 Jun 2025·Toxicology reports

Rising incidence of recreational ketamine use: Clinical cases and management in emergency settings

Article

Author: Franssen, Eric J F ; Croes, Esther A ; van Eijk, Maarten ; Marongiu, Sabrina ; Gresnigt, Femke M J

The recreational use of ketamine has risen significantly in the Netherlands, particularly among young adults in nightlife settings. This trend has been accompanied by an increase in first aid incidents involving ketamine, often in combination with other substances such as alcohol or MDMA, leading to heightened toxicity. Acute intoxication with ketamine manifests through symptoms like agitation, hallucinations, nausea, tachycardia, and hypertension, while frequent use is associated with long-term complications, including ketamine-induced uropathy. Although ketamine is not currently included in standard toxicological screenings, its detection can aid in diagnosing mixed intoxications, excluding alternative causes, and facilitating referral to follow-up care. Routine inclusion of ketamine in toxicological screening could improve diagnostic precision and better address the health risks associated with its growing prevalence.

01 Jun 2025·FOOD CHEMISTRY

High-throughput screening of new psychoactive substances and related compounds in food by UHPLC-Q/Orbitrap

Article

Author: Huang, Xia ; Wan, Yuping ; Shi, Peiyu ; Wu, Wenlin ; Xiao, Quanwei ; Liu, Shiyao ; Guo, Tianrong ; Zhang, Min ; Xia, Bing ; Zhou, Yan ; Chen, Xiaoqi

Currently, there is concern about food products to which new psychoactive substances (NPS) have been added illegally. However, rapid, high-sensitivity, and high-throughput screening methods for such harmful substances have not been reported yet. In this study, a high-throughput non-targeted screening strategy was developed based on UHPLC-Q/Orbitrap. First, optimized pretreatment methods for typical high-risk matrices were established. Second, an accurate, efficient, and scalable high resolution mass spectrometry database containing 206 NPS and related compounds was constructed. The fragmentation pathways of three different types of fentanyl-related compounds were then systematically investigated to enhance compound identification. Additionally, a non-targeted screening strategy was developed using warning ions derived from 24 fentanyl-related compounds, streamlining the identification of NPS. This strategy was applied to 100 food samples with possible illegal additives and demonstrated its effectiveness. In summary, this study provides robust technical support for regulatory authorities in combating the illegal addition of food products.

418

News (Medical) associated with Methylenedioxymetamfetamine

31 Mar 2025

·endpts.com

Exclusive: Transcend notches Phase 2 win to treat PTSD, invigorating budding neuroplastogen class

Transcend Therapeutics’ PTSD treatment succeeded in a mid-stage study, propelling the scrappy company of less than 20 people toward a Phase 3 trial that could begin at the start of next year. The placebo-controlled results are the first for the company’s non-hallucinogenic psychostimulant treatment, methylone, or TSND-201. Though not a psychedelic, the drug fits within the broader and emerging class of neuroplastogen companies trying to turn therapies out of the brain’s ability to reorganize and build new neural connections. Transcend showed that TSND-201 beat placebo in improving patients’ PTSD symptoms, as measured by a clinical scale. The treatment showed both a short- and long-term impact, with statistically significant improvements in CAPS-5 scores at both day 10 and day 64. Patients receiving treatment had an 8-point placebo-adjusted improvement in symptoms at day 10 and a 9.64 improvement at day 64. Almost 61% of patients treated with TSND-201 shed their PTSD diagnosis, twice the rate of placebo. The data made CEO Blake Mandell feel hopeful and encouraged, reflecting on the dearth of treatments for patients. “The average duration of PTSD symptoms for patients in the study was like 20 years,” he said in an exclusive interview with Endpoints News . “And by 10 days, there was a clear separation from placebo.” The study recruited 65 patients with severe PTSD across the US, UK and Ireland who had previously been treated for the condition. Participants were given four oral doses of either treatment or placebo, each separated by a week. The data at day 10 followed the patients’ second treatment course. The majority of adverse events occurred on the day of dosing and resolved that day. One patient in the treatment arm who had a history of seizures experienced one seven days after the last dose, but the event was deemed unrelated to the study drug. Transcend is among the crop of biotechs that are trying to harness the power of psychedelics without patients tripping or hallucinating. Other companies, like Delix Therapeutics and Gilgamesh, are working on similar therapies. Patients in Transcend’s trial still had to be monitored for at least eight hours in the study, and Mandell described a range of experiences. Some were more chatty, others were introspective; a number of patients had a positive adverse reaction described as “non-sedated relaxation.” “I imagine it’s important for the agency to be able to understand what is happening to these patients in the study. And the more data we can collect, the more helpful it is for them,” he said. The level of detail on side effects is not just a show of good faith. Mandell and Transcend are looking to learn from Lykos Therapeutics, which stumbled last year on the path to treating PTSD. That company, developing MDMA as central to psychedelic-assisted therapy, faced an FDA rejection despite two successful Phase 3 studies. The agency ultimately didn’t trust the data, and issues about integrity and adverse event monitoring plagued the company. “Everything different from baseline was tracked,” Mandell said. Patient monitors were instructed to be non-directive with patients and to only assist if patients needed it. One monitor was removed for continuously directing patients contrary to the agreed-upon approach, Mandell said. Unlike Lykos, TSND-201 is not being tested as assisting psychotherapy, hence the nondirective guidance. Transcend, like Lykos, used central raters to assess patients’ CAPS-5 scores to try to limit bias from trial investigators, meaning people who didn’t work with the patients during the dosing session were assessing their PTSD symptoms afterward. The biotech has raised $50 million to date, enough to get it to the end of the year when it plans to be ready to launch a Phase 3 study. Between now and then, Transcend will meet with the FDA to align on that study, which will include discussing a potential tweak to the monitoring time, according to Mandell. And it will need to raise more money. “Our path is to tell the story and try to raise the capital to begin a pivotal program,” he said. Editor’s note: This story was updated to correct that the case of seizure occurred after the last dose of TSND-201, not the second dose.

Clinical ResultPhase 2Phase 3

24 Mar 2025

·www.globenewswire.com

PharmAla Contracts with Partner to Act as US Distributor

TORONTO, March 24, 2025 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC:MDXXF), a biotechnology company focused on the research, development, and manufacturing of novel MDXX class molecules (including its LaNeo™ MDMA), is pleased to announce that it has contracted with a third party logistics company specializing in pharmaceutical products to act as its US clinical trial distribution partner. “PharmAla has noted over the past months that US-Canada cross-border shipping uncertainty has increased. This uncertainty is negatively impacting our numerous clinical trial customers in the United States,” said Nicholas Kadysh, CEO, PharmAla Biotech. “As our volume of business in the US grows, we are always looking for ways to optimize our work; with the potential imposition of tariff barriers, we believe that this is even more important. We are pleased to have contracted with an exceptionally capable partner to store and distribute our LaNeo™ clinical trial materials on behalf of both ourselves and our US clients.” PharmAla’s agreement with its partner should provide for a streamlined warehoused, GMP-compliant supply of LaNeo™ MDMA for all current clients already contracted, and should provide exceptional certainty against import/export risks for future clients seeking to purchase LaNeo™ MDMA for clinical trials in the United States. The agreement is non-exclusive, and does not include any provision for sales of LaNeo™ MDMA. The partner will act on PharmAla’s behalf only in the storage and directed distribution of PharmAla’s products. The name of PharmAla’s logistics partner is being withheld at their request. This follows the announcement, two weeks ago, that PharmAla had secured a permanent and exclusive licensed distribution agreement with Duchefa Farma in the Netherlands. About PharmAla PharmAla Biotech Holdings Inc. (CSE: MDMA)(OTCQB: MDXXF) is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials as well as commercial sales in selected jurisdictions, and to develop novel drugs in the same class. PharmAla is the only company currently provisioning clinical-grade MDMA for patient treatments outside of clinical trials. PharmAla’s research and development unit has completed proof-of-concept research into several IP families, including ALA-002, its lead drug candidate. PharmAla is a “regulatory first” organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators. For more information, please contact:Nicholas KadyshChief Executive OfficerPharmAla Biotech Holdings Inc.Email: press@PharmAla.caPhone: 1-855-444-6362Website: www.PharmAla.ca Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release. Cautionary Statement This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmAla’s current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by PharmAla at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. The forward-looking information contained in this press release is made as of the date hereof, and PharmAla is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in PharmAla’s management’s discussion and analysis which is available on PharmAla’s profile at www.sedar.com. This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

License out/in

21 Mar 2025

·www.globenewswire.com

PharmAla Completes Shipment of LaNeo™ MDMA to the University of Washington

TORONTO, March 21, 2025 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC:MDXXF), a biotechnology company focused on the research, development, and manufacturing of novel MDXX class molecules (including its LaNeo™ MDMA), is pleased to announce that it has successfully completed an international shipment of LaNeo™ MDMA to the University of Washington, USA. This continues the fulfillment of orders from important human research studies in the United States that have chosen to use Phamala’s pharmaceutical grade LaNeo™ MDMA capsules for their clinical research. “While we’re incredibly pleased to have delivered a supply of LaNeo™ MDMA to the University of Washington, it has become apparent that US-Canada cross-border trade uncertainty is an ongoing risk for clients,” said Dr. Shane Morris, COO, PharmAla Biotech. “As a result, the PharmAla team is working hard to mitigate such uncertainty , and we look forward to announcing a solution soon.” Pharmala notes that is regrettable that important US research is detrimentally impacted by tariffs, and calls for all investigational drug products destined for US funded health research studies at US institutions to be exempt from tariffs. By global convention, all investigational drugs destined for clinical research are usually shipped tariff-free. Appointment of Ali Taghva as Chief Commercial Officer PharmAla is furthermore pleased to announce that Mr. Ali Taghva will take on new responsibilities, acting as Chief Commercial Officer to the Company, as well as Counsel to the Company. For more information, please visit www.PharmAla.ca, where you can sign up to receive regular news updates. About PharmAla PharmAla Biotech Holdings Inc. (CSE: MDMA)(OTCQB: MDXXF) is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials as well as commercial sales in selected jurisdictions, and to develop novel drugs in the same class. PharmAla is the only company currently provisioning clinical-grade MDMA for patient treatments outside of clinical trials. PharmAla’s research and development unit has completed proof-of-concept research into several IP families, including ALA-002, its lead drug candidate. PharmAla is a “regulatory first” organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators. For more information, please contact:Nicholas KadyshChief Executive OfficerPharmAla Biotech Holdings Inc.Email: press@PharmAla.caPhone: 1-855-444-6362Website: www.PharmAla.ca Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release. Cautionary Statement This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmAla’s current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by PharmAla at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. The forward-looking information contained in this press release is made as of the date hereof, and PharmAla is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in PharmAla’s management’s discussion and analysis which is available on PharmAla’s profile at www.sedar.com. This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

Executive Change

100 Deals associated with Methylenedioxymetamfetamine

External Link

KEGG	Wiki	ATC	Drug Bank
-	Methylenedioxymetamfetamine	-	DB01454

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Stress Disorders, Post-Traumatic	NDA/BLA	United States	Lykos Therapeutics, Inc.Startup	13 Dec 2023
Anorexia Nervosa	Phase 2	-	Lykos Therapeutics, Inc.Startup	01 Feb 2026
Binge-Eating Disorder	Phase 2	-	Lykos Therapeutics, Inc.Startup	01 Feb 2026
Alcoholism	Phase 2	-	Awakn Life Sciences, Inc.	05 May 2022
Anxiety Disorders	Phase 2	United States	Lykos Therapeutics, Inc.Startup	14 May 2015
Autistic Disorder	Phase 2	United States	Lykos Therapeutics, Inc.Startup	11 Apr 2014
Liver Injury	Phase 1	United States	Lykos Therapeutics, Inc.Startup	29 Mar 2026
Hyperexplexia Hereditary	Phase 1	United States	Lykos Therapeutics, Inc.Startup	14 Mar 2017
Depressive Disorder	Preclinical	Canada	Revive Therapeutics Ltd.	03 Feb 2023
Depressive Disorder	Preclinical	Canada	PharmaTher Holdings Ltd.	03 Feb 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04030169 (CTgov)	Phase 2	Stress Disorders, Post-Traumatic	21	Midomafetamine HCl	bgvrvtxmkr(zthbkpjtyo) = vpsdimnhej iooyfrjpnw (euslpvryhp, ttvnbxrtxi - swqqwvvjgb) View more	-	28 Jan 2025
NCT04714359 (MAPPUSX, CTgov)	Phase 3	Stress Disorders, Post-Traumatic	87	Midomafetamine HCl	pkclycphkw(hrjrrekcvm) = pjvdbtzwug lvddwfirnw (vujhgdtmmh, ylhwqzvttv - yhsxcyasvc) View more	-	29 Nov 2024
NCT03790618 (ESP, CTgov)	Phase 1	-	36	3,4-Methylenedioxymethamphetamine+methamphetamine (Placebo)	nguhnwrvix(fhreizxwbb) = nrrqmamdcb jvovxidawt (jlmozpshnw, 3.22) View more	-	05 Jan 2024
NCT03790618 (ESP, CTgov)	Phase 1	-	36	3,4-Methylenedioxymethamphetamine+methamphetamine (Low Dose MDMA)	nguhnwrvix(fhreizxwbb) = hvkrnjyhrw jvovxidawt (jlmozpshnw, 3.14) View more	-	05 Jan 2024
NCT04077437 (MAPP2, CTgov)	Phase 3	Stress Disorders, Post-Traumatic	121	Therapy+Midomafetamine (Experimental: MDMA-assisted Psychotherapy)	ciijvkzscq(loumlsebwt) = wsfimqukxg zeysccuxzo (fpuvsktleb, fjvsndebyi - ryrhibfpel) View more	-	11 Oct 2023
NCT04077437 (MAPP2, CTgov)	Phase 3	Stress Disorders, Post-Traumatic	121	Placebo (Placebo Comparator: Placebo)	ubrdodvjsi(aeyrrrpjrs) = ufqhdylukm xldiygrqii (vlhsvdtvvv, prumxneshp - ybycuvdwpd)	-	11 Oct 2023
OR17-01 (ENDO2023)	Not Applicable	Diabetes Insipidus, Neurogenic oxytocin	30	MDMA (Ecstasy)	ffvoaorkjh(dscwfhqsnk) = ykxhwqrple panmlexazx (zsuvlzelrv, 3 - 17) View more	Positive	05 Oct 2023
OR17-01 (ENDO2023)	Not Applicable	Diabetes Insipidus, Neurogenic oxytocin	30	Placebo	ffvoaorkjh(dscwfhqsnk) = rzkgzfmflm panmlexazx (zsuvlzelrv, 0 - 2) View more	Positive	05 Oct 2023
IEC2023	Not Applicable	EEG activity	-	MDMA (Non-substance users)	zzqkwxgzfa(tsxuubsccp) = whavsizamo qoxpvjjfds (vvsrsnmhwf, +/ - 1.5)	Negative	04 Sep 2023
NCT01211405 (CTgov)	Phase 2	Stress Disorders, Post-Traumatic	26	MDMA (Low Dose MDMA (30 mg))	hdentydtxt(gswfublpod) = vplsqgrrim kwnqhplbtb (mkiulruxfr, 14.1) View more	-	02 Feb 2022
NCT01211405 (CTgov)	Phase 2	Stress Disorders, Post-Traumatic	26	MDMA (Medium Dose MDMA (75 mg))	hdentydtxt(gswfublpod) = zvzrhugaxp kwnqhplbtb (mkiulruxfr, 17.3) View more	-	02 Feb 2022
NCT01458327 (CTgov)	Phase 2	Stress Disorders, Post-Traumatic	3	3,4-methylenedoxymethamphetamine (MDMA)	giucusezzx(jmubvitsdw) = nlnmqagjqn lxffsrtfen (bmtgcdybud, 1.53) View more	-	03 Nov 2021
NCT00090064 (CTgov)	Phase 2	Stress Disorders, Post-Traumatic	23	Lactose placebo pill	tgqklfbhcy(ignjuejjvz) = afdzqvdwqh bwgsjibyac (jlaeegwwya, 20.47) View more	-	25 Oct 2021

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