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 / Not yet recruitingPhase 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

6,326

Literatures (Medical) associated with Methylenedioxymetamfetamine

01 Feb 2025·FORENSIC SCIENCE INTERNATIONAL

Estimating illicit production of MDMA from its production waste, a Dutch case study

Article

Author: de Voogt, Pim ; Mehlbaum, Shanna ; Emke, Erik ; Ter Laak, Thomas L ; van den Berg, Jorrit

The Netherlands plays a key role in the global production of the synthetic illicit drug MDMA. However, the actual Dutch production of MDMA is difficult to quantify. The illicit production of MDMA results in large amounts of waste. This study uses amounts of waste found in the environment and production-related MDMA residues in wastewater to estimate the amount of MDMA that is produced. The MDMA produced, associated to the amount of waste found in the environment is 4.2 and 5.8 tons per year for two common synthesis routes. The MDMA produced, associated to production-related residues in wastewater is significantly larger, with 39.2 tons per year. The estimated MDMA production associated to waste in the environment and wastewater analysis is 43.4 and 45.0 tons per year for two common synthesis routes. Even though these estimates are difficult to validate, they are feasible when compared to prevalence-based consumption estimates or production estimates based on interceptions of precursors. The current study illustrates that waste of an illicit industry can shed light on its production volumes, thereby, complementing other efforts to estimate production, trade and use of synthetically produced illicit substances.

01 Feb 2025·Journal of substance use and addiction treatment

Treatment completion among Australians attending publicly-funded specialist alcohol and other drug treatment services

Article

Author: Raubenheimer, Jacques ; Stoove, Mark ; Day, Carolyn A ; Dietze, Paul ; Haber, Paul S ; Roxburgh, Amanda ; Roberts, Darren M ; Reid, Sharon ; Van Buskirk, Joseph

INTRODUCTION:

Completion of alcohol and other drug (AOD) treatment is associated with improved health and social outcomes. Previous research has largely focused on individual (e.g. demographic) or service-level (e.g. treatment modality/setting) factors related to treatment completion in isolation. This study investigates the relationship between treatment completion and service-level and substance related factors, after controlling for demographics.

STUDY DESIGN:

Retrospective cohort of 53,430 people engaging in government funded specialist AOD treatment across New South Wales, Australia, between 1 January 2015-31 December 2018.

METHODS:

Generalised linear mixed models were used to analyse factors associated with treatment completion, accounting for repeated measures across treatment episodes.

RESULTS:

Approximately two-thirds (69.8 %, n = 37,330) of the cohort completed treatment at least once during the study period, 42.3 % (22,605) on a single, and 27.5 % (14,725) on multiple occasions. After controlling for demographics, treatment episodes for amphetamines were least likely to be recorded as complete (52.5 %), while those for MDMA were 1.9 (95 % CI: 1.49, 2.45) times more likely (67 %) than amphetamine episodes to be completed. Treatment episodes mandated through criminal justice/child protection agencies were 1.25 (95 % CI: 1.20, 1.30) times more likely to be completed compared to those originating from self-referral. There were no differences in treatment completion between self or health professional referrals (aOR: 0.98, 95 % CI: 0.95, 1.02). Episodes involving involuntary AOD treatment modalities and residential withdrawal were 6.67 times (95% CI: 4.53, 9.81) and 5.02 times (95 % CI: 4.46, 5.64) more likely respectively to be completed compared to those for community rehabilitation. Case management episodes were also more likely (aOR: 2.43, 95 % CI: 2.16, 2.73) to be completed. Episodes of longer treatment duration (≥90 days) were 1.89 times (95 % CI: 1.82, 1.97) more likely to be completed compared to shorter (≤30 days) treatment episodes.

CONCLUSIONS:

Treatment completion was moderated by a range of factors including drug type, treatment modality and duration, and referral source. Low rates of amphetamine treatment completion across treatment modalities confirms the urgent need for further research investigating more effective treatment options for amphetamine use disorders.

01 Jan 2025·ADDICTION

Comparison of strength and adulteration between illicit drugs obtained from cryptomarkets versus off‐line

Article

Author: Peacock, Amy ; Barratt, Monica J. ; van der Gouwe, Daan ; Ventura, Mireia ; Smit‐Rigter, Laura ; Hutten, Nadia ; Quesada, Adrià ; Coney, Leigh

Abstract:

Background and aims:

Drugs sold on cryptomarkets are thought to have lower levels of adulteration and higher strength compared with those sourced off‐line. The present study aimed to determine whether cryptomarket and off‐line‐sourced 3,4‐methylenedioxy‐N‐methamphetamine (MDMA), cocaine, amphetamine, methamphetamine and lysergic acid diethylamide (LSD) differed in adulteration and strength.

Design and setting:

A between‐groups design was used to compare cryptomarket versus off‐line‐sourced drugs. Regression analyses controlling for year and service were conducted. Drug‐checking services were conducted in Spain (Energy Control) and the Netherlands (Drugs Information and Monitoring System).

Cases:

The cases comprised drug samples that underwent drug checking between 2016 and 2021 and were expected to contain MDMA (tablets; n = 36 065; powder: n = 6179), cocaine (n = 11 419), amphetamine (n = 6823), methamphetamine (n = 293) and LSD (n = 1817).

Measurements:

Drugs were measured for (1) matching the advertised substance (i.e. containing any amount of the expected substance); (2) strength; (3) presence of adulteration; and (4) number of adulterants.

Findings:

The expected drug was more likely to be identified when sourced from cryptomarkets versus off‐line for MDMA tablets [adjusted odds ratio (AOR) = 2.10, 95% confidence interval (CI) = 1.28–3.43], MDMA powder (AOR = 2.64, CI = 1.55–4.51), cocaine (AOR = 3.65, CI = 1.98–6.71) and LSD (AOR = 1.75, CI = 1.13–2.72). Cryptomarket‐sourced MDMA powder (β = 0.03, P = 0.012), cocaine (β = 0.08, P < 0.001) and methamphetamine (β = 0.15, P = 0.028) were statistically significantly higher in strength than substances from off‐line sources. Conversely, MDMA tablets (β = −0.01, P = 0.043) and amphetamine (β = −0.07, P < 0.001) from cryptomarkets were statistically significantly lower in strength than from off‐line sources. MDMA powder (AOR = 0.53, CI = 0.33–0.86) and cocaine (AOR = 0.66, CI = 0.55–0.79) were statistically significantly less likely to be adulterated if sourced from cryptomarkets. However, amphetamine (AOR = 1.54, CI = 1.25–1.90) and LSD (AOR = 1.31, CI = 1.00–1.71) were found to be more likely to be adulterated when purchased from cryptomarkets. Cocaine from cryptomarkets exhibited fewer adulterants (incidence rate ratio = 0.71, CI = 0.60–0.85).

Conclusion:

The relationship between on‐line drug market‐places and substance quality varies depending on both the specific substance and the dynamics of the cryptomarket.

374

News (Medical) associated with Methylenedioxymetamfetamine

20 Dec 2024

·www.globenewswire.com

PharmAla Issues Audited Financial Statements, Completes Continuance to Ontario, and Closes Private Placement

TORONTO, Dec. 20, 2024 (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 LaNeo™ MDMA and novel derivatives of MDMA (MDXX class molecules), is pleased to announce its financial and operational results for the year ended August 31, 2024, the highlights of which are included in this news release. All figures are reported in Canadian dollars. The Company’s full set of consolidated audited financial statements for the years ended August 31, 2024 and 2023 and accompanying management’s discussion and analysis can be accessed by visiting the Company’s website at www.PharmAla.ca and its profile page on SEDAR+ at www.sedarplus.ca. “While the previous year saw significant setbacks for some companies, I believe that PharmAla has only moved from strength to strength; In my opinion, our financial performance reflects that,” said Nick Kadysh, CEO, PharmAla Biotech. “We’ve added significant new talent to our team, including our CFO, Will Avery. Our revenue growth continued at pace, and we are working hard so that it may continue to do so.” Financial Highlights: Fiscal 2024 Revenue of over $1.0M representing growth of $503,000 or 95% year over year, lead by growth in MDMA product sales of $723,000 a $305,000 or 73% increase year over yearFiscal 2024 Adjusted EBITDA1 of ($55,000) compared to fiscal 2023 ($659,000), a $605,000 year over year improvement, driven primarily by revenue growth.The Company was granted patents for two novel MDXX molecules, APA-01 and ALA-002, during fiscal 2024, as a result costs capitalized with respect to these commenced amortization during Fiscal 2024.During Fiscal 2024, we generated $772,000 in net proceeds from the issuance of shares and exercise of options, and used cash in operations of $321,000 and invested $226,000 of cash in the development of intangible assets, ending the year with $419,000 of cash. _______________1 Earnings before interest, taxes, depreciation, and amortization (“EBITDA”) and adjusted EBITDA. These measures do not have a standardized meaning prescribed by International Financial Reporting Standards (“IFRS”) and are, therefore, unlikely to be comparable to similar measures presented by other issuers. Non-IFRS measures provide investors with a supplemental measure of the Company’s operating performance and, therefore, highlight trends in the Company’s core business that may not otherwise be apparent when relying solely on IFRS measures. Management uses non-IFRS measures in measuring the financial performance of the Company. Adjusted EBITDA adjusts net loss and comprehensive loss for non-cash items such as stock based compensation, depreciation and amortization and deferred joint venture portion of sales. For factors PharmAla believes are relevant in disclosing Adjusted EBITDA, see the Company’s financial statements and associated management discussion and analysis. “The PharmAla team is proud of the results we have achieved with the growth in product sales and the major milestones achieved during the year ended August 31, 2024,” said Will Avery, CFO, PharmAla Biotech. “We believe in the quality of our team and, most importantly, the quality of our product and we look forward to building on the success of this past year.” PharmAla Announces Completion of Continuance In addition, the Company is pleased to announce that, further to its press release dated March 8, 2024, effective December 17, 2024, it has completed its continuance from the Province of British Columbia governed under the Business Corporations Act (British Columbia) into the Province of Ontario governed under the Business Corporations Act (Ontario) (the “Continuance”). The Continuance was approved by the Company’s shareholders at its annual general and special meeting held on February 27, 2024. No action will be required by existing shareholders with respect to the Continuance. Closing of Private Placement In addition, the Company is pleased to announce that, further to its press release dated December 13, 2024 (the “December 13 Release”), the Company has closed its previously announced non-brokered private placement offering (the “Offering”) effective today (the “Closing Date”) through the issuance of 8,676,221 Units for aggregate gross proceeds of $1,561,719.88. The Offering was oversubscribed by 12% with an additional 898,444 Units sold as compared to December 13 Release. Capitalized terms not otherwise defined herein have the meanings attributed to them in the December 13 Release. Each Unit was sold at a price of $0.18 per Unit and consisted of one Common Share and one-half of one Warrant. Each whole Warrant entitles the holder thereof to acquire one Additional Share at a price of C$0.27 per Additional Share at any time prior to 4:30 pm (Toronto Time) on the date that is thirty six months following the Closing Date, provided that, if the closing price of the Common Shares on the CSE is $0.38 or greater per Common Share for a period of ten consecutive trading days at any time after the completion of the Offering, the Company may accelerate the Warrant Term, in compliance with the policies of the CSE, such that the Warrants shall expire on the date which is thirty days following the date a press release is issued by the Company announcing the reduced Warrant Term in accordance with the terms and conditions of the certificate representing such Warrants, as further outlined in the December 13 Release. The Company intends to use the net proceeds of the Offering for the securing of global patent rights for its portfolio of novel intellectual property assets, manufacture of products for sale, clinical trails into the Company’s novel patented drug candidates, sales, general corporate and working capital purposes. Securities issued under the Offering were, as applicable, subject to (i) a four month and one day hold period from the date of issuance and (ii) applicable legends as required pursuant to the United States Securities Act of 1933, as amended. 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 CSE nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release. Cautionary Note Regarding Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of applicable securities laws. All statements contained herein that are not clearly historical in nature may constitute forward-looking statements. Generally, such forward-looking information or forward-looking statements can be identified by the use of forward-looking terminology such as “plans”, “strategy”, “expects” or “does not expect”, “intends”, “continues”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or may contain statements that certain actions, events or results “will be taken”, “will launch” or “will be launching”, “will include”, “will allow”, “will be made” “will continue”, “will occur” or “will be achieved”. The forward-looking information and forward-looking statements contained herein include, but are not limited to, statements regarding the use of proceeds from the Offering, the Company continuing to grow its revenue and the Company building on the success of this past year. Readers are cautioned to not place undue reliance on forward-looking information. Actual results and developments may differ materially from those contemplated by these statements. Although the Company believes that the expectations reflected in these statements are reasonable, such statements are based on expectations, factors, and assumptions concerning future events which may prove to be inaccurate and are subject to numerous risks and uncertainties, certain of which are beyond the Company’s control, including but not limited to the risk factors discussed under the heading “Risk Factors” in the Company’s management’s discussion and analysis, and elsewhere in this press release, as such factors may be further updated from time to time in our periodic filings, available at www.sedarplus.ca, which factors are incorporated herein by reference. Forward-looking statements contained in this press release are expressly qualified by this cautionary statement and reflect the Company’s expectations as of the date hereof and are subject to change thereafter. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, estimates or opinions, future events or results, or otherwise, or to explain any material difference between subsequent actual events and such forward-looking information, except as required by applicable law. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful. The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the United States Securities Act of 1933, as amended, and applicable state securities laws.

Financial Statement

13 Dec 2024

·www.globenewswire.com

PharmAla Announces Private Placement

TORONTO, Dec. 13, 2024 (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 LaNeo™ MDMA and novel derivatives of MDMA (MDXX class molecules), is pleased to announce its intention to complete a non-brokered private placement offering of units of the Company (each, a “Unit”) at a price of $0.18 per Unit for aggregate gross proceeds of $1,400,000 (the “Offering”) or such greater amount at the discretion of the company. The offering may be oversubscribed. It is anticipated that the Offering will be purchased primarily by a single high-net-worth strategic investor. Each Unit shall consist of one common share in the share capital of the Company (each, a “Common Share”) and one-half of one (0.5) Common Share purchase warrant of the Company (each whole warrant, a “Warrant”). Each Warrant will entitle the holder thereof to acquire one additional Common Share (each, an “Additional Share”) at a price of $0.27 per Additional Share at any time prior to 4:30 pm (Toronto Time) on the date that is thirty six months following the closing date (the “Warrant Term”), provided that, if the closing price of the Common Shares on the Canadian Securities Exchange (the “CSE”) is $0.38 or greater per Common Share for a period of ten consecutive trading days at any time after the completion of the Offering, the Company may accelerate the Warrant Term, in compliance with the policies of the CSE, such that the Warrants shall expire on the date which is thirty days following the date a press release is issued by the Company announcing the reduced Warrant Term in accordance with the terms and conditions of the certificate representing such Warrants. The Company intends to use the net proceeds of the Offering for the securing of global patent rights for its portfolio of novel intellectual property assets, manufacture of products for sale, clinical trails into the Company’s novel patented drug candidates, sales, general corporate and working capital purposes. The Units will be offered to qualified purchasers in reliance upon exemptions from prospectus and registration requirements of applicable securities legislation. The Company may pay finders' fees to eligible finders in connection with the Offering, subject to compliance with applicable securities laws and CSE policies. All securities proposed to be issued in connection with the Offering will be subject to a statutory hold period of four months and one day from the date of issuance. The Offering is expected to close on or about December 20th, 2024, subject to customary closing conditions and compliance with CSE policies. 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 CSE nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release. Cautionary Note Regarding Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of applicable securities laws. All statements contained herein that are not clearly historical in nature may constitute forward-looking statements. Generally, such forward-looking information or forward-looking statements can be identified by the use of forward-looking terminology such as “plans”, “strategy”, “expects” or “does not expect”, “intends”, “continues”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or may contain statements that certain actions, events or results “will be taken”, “will launch” or “will be launching”, “will include”, “will allow”, “will be made” “will continue”, “will occur” or “will be achieved”. The forward-looking information and forward-looking statements contained herein include, but are not limited to, statements regarding: the Company’s intention to complete the Offering and Debt Settlement; the Offering and Debt Settlement being conducted in accordance with the policies of the CSE and applicable securities laws; the Offering’s anticipated size, timing of closing, placees and use of proceeds; and the anticipated completion of the entire Offering under the stated terms. Readers are cautioned to not place undue reliance on forward-looking information. Actual results and developments may differ materially from those contemplated by these statements. Although the Company believes that the expectations reflected in these statements are reasonable, such statements are based on expectations, factors, and assumptions concerning future events which may prove to be inaccurate and are subject to numerous risks and uncertainties, certain of which are beyond the Company’s control, including but not limited to the risk factors discussed under the heading “Risk Factors” in the Company’s management’s discussion and analysis, and elsewhere in this press release, as such factors may be further updated from time to time in our periodic filings, available at www.sedarplus.ca, which factors are incorporated herein by reference. Forward-looking statements contained in this press release are expressly qualified by this cautionary statement and reflect the Company’s expectations as of the date hereof and are subject to change thereafter. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, estimates or opinions, future events or results, or otherwise, or to explain any material difference between subsequent actual events and such forward-looking information, except as required by applicable law. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful. The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the United States Securities Act of 1933, as amended, and applicable state securities laws.

11 Dec 2024

·endpts.com

Exclusive: Negev Labs unveils with $30M in assets, striving to build a network of psychedelic biotechs

A new psychedelic-focused startup incubator is debuting, backed by an investor behind some of the most prominent biotechs in the space. The main theme of the companies it wants to build? No tripping. Negev Labs is an offshoot of Negev Capital. Founded in 2022 and equipped with $30 million in assets, New Jersey-based Negev Labs jumped out of stealth Wednesday with a library of compounds from the Alexander Shulgin Research Institute and the ophthalmology program from Beckley Psytech. The goal is to build a suite of venture-backed biotechs focused on developing neuroplastogens, an up-and-coming class of psychedelics that can change the brain’s structure and function, but without the hallucinations that can come with other psychedelics. Delix Therapeutics, one of Negev Capital’s portfolio companies, is an example of the science Negev Labs hopes to advance. Delix raised one of the largest private rounds for a psychedelic company and counts RA Capital as a Series A investor. “It’s not possible just one company, even [a] great company like Delix, will cover all the market,” Ken Belotsky, co-founder of both Negev Labs and Negev Capital, said in an interview. At Negev Labs’ disposal will be “two families of compounds” from the Alexander Shulgin Research Institute. The psychedelic research center was born out of work by Sasha Shulgin, who was a pioneer in the field and colloquially known as “the godfather of ecstasy.” Shulgin’s work synthesizing methylenedioxymethamphetamine (MDMA) helped usher in a new wave of research supporting its therapeutic use, despite being listed as a schedule 1 substance by the US Drug Enforcement Agency. When Shulgin passed away, he left the institute with about 500 finished psychedelic compounds, known as the “Shulgin vault,” fellow institute co-founder Nicholas Cozzi said in a separate interview. He, Paul Freeman Daley and Sasha’s wife Ann carried on Shulgin’s mission before Ann died in 2022. Cozzi and Daley have carried the torch since then. Cozzi said that Negev will have access to “some of the compounds, but so far, it’s just a limited set.” Shlomi Raz, a partner at Negev Labs, told Endpoints that the target of almost every drug that the firm will develop will be the serotonin 2A receptor, which is associated with the brain’s ability to restructure its neural networks. Raz also helped negotiate Negev Labs’ acquisition of the ophthalmology program from Beckley Psytech, where he was the chief business officer. Data from Beckley suggested that “sustained delivery depots” into the fluid that lines the eye at amounts that would not spur a psychedelic effect could still produce significant benefits for a handful of ocular diseases. Negev Labs has not yet announced its first company but plans to do so soon, Raz teased, saying it will focus on Parkinson’s. As for future financing, the firm is now “fully funded by external investors,” Belotsky said. In fact, Negev Capital no longer invests, after deploying the roughly $30 million first fund it closed in 2022 and failing to raise a second in 2023. Belotsky said he’s still supporting those companies — including Delix, Gilgamesh and atai Life Sciences — but most of his focus is on getting Negev Labs off the ground. “I just decided, ‘OK, we don’t have results in fundraising, but we have wonderful results in Negev Labs. And we have investors who are interested in this business model,’” he said.

Acquisition

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	US	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	US	Lykos Therapeutics, Inc.Startup	14 May 2015
Autistic Disorder	Phase 2	US	Lykos Therapeutics, Inc.Startup	11 Apr 2014
Liver Injury	Phase 1	US	Lykos Therapeutics, Inc.Startup	29 Mar 2026
Stiff-Person Syndrome	Phase 1	US	Lykos Therapeutics, Inc.Startup	14 Mar 2017
Depressive Disorder	Preclinical	CA	PharmaTher Holdings Ltd.	03 Feb 2023
Depressive Disorder	Preclinical	CA	Revive Therapeutics Ltd.	03 Feb 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04714359 (MAPPUSX, CTgov)	Phase 3	Stress Disorders, Post-Traumatic	87	Midomafetamine HCl	ynmdkcwoes(vptivkoixb) = hjllgaoaxt sdncutrrce (tednfbscuv, szmlsigtqh - qvzvugrofo) View more	-	29 Nov 2024
NCT03790618 (ESP, CTgov)	Phase 1	-	36	3,4-Methylenedioxymethamphetamine+methamphetamine (Placebo)	lpvhohjayr(kcxsgtprhq) = ffoqwxcifk ksxxnkshak (jveaufhhll, uifbuwuhoe - mlmfvgwbbu) View more	-	05 Jan 2024
NCT03790618 (ESP, CTgov)	Phase 1	-	36	3,4-Methylenedioxymethamphetamine+methamphetamine (Low Dose MDMA)	lpvhohjayr(kcxsgtprhq) = rbhwwqmeft ksxxnkshak (jveaufhhll, lxshcmvwfv - pomqpnaduy) View more	-	05 Jan 2024
NCT04077437 (MAPP2, CTgov)	Phase 3	Stress Disorders, Post-Traumatic	121	Therapy+Midomafetamine (Experimental: MDMA-assisted Psychotherapy)	qlktpizjti(rjmnoopeba) = bgleplcnyp oeygianeol (jfblmaksha, ycpvqmnbqm - xvelvrelgg) View more	-	11 Oct 2023
NCT04077437 (MAPP2, CTgov)	Phase 3	Stress Disorders, Post-Traumatic	121	Placebo (Placebo Comparator: Placebo)	krzrumxwbv(vahsvogwqw) = euarrtgauv ulhilgbpww (vhdzvtbsep, ckcqmnkjgm - soosvibdid)	-	11 Oct 2023
OR17-01 (ENDO2023)	Not Applicable	Diabetes Insipidus, Neurogenic oxytocin	30	MDMA (Ecstasy)	zqwhqhjxkj(ztbyxcoifl) = xuzweogzci fdhjjfyyow (btzldnlror, 3 - 17) View more	Positive	05 Oct 2023
OR17-01 (ENDO2023)	Not Applicable	Diabetes Insipidus, Neurogenic oxytocin	30	Placebo	zqwhqhjxkj(ztbyxcoifl) = nlxzrsbmcl fdhjjfyyow (btzldnlror, 0 - 2) View more	Positive	05 Oct 2023
IEC2023	Not Applicable	EEG activity	-	MDMA (Non-substance users)	fsgatzfiur(gkcrmvkhap) = rizymechem vxcfhfqpxb (uopcisvijl, +/ - 1.5)	Negative	04 Sep 2023
NCT01211405 (CTgov)	Phase 2	Stress Disorders, Post-Traumatic	26	MDMA (Low Dose MDMA (30 mg))	irdamyqsbf(jzetnqgwkp) = gkrpvhglgp kugqgsnrhz (ynnnqooavn, fvjylvxgil - apzdnbrlmj) View more	-	02 Feb 2022
NCT01211405 (CTgov)	Phase 2	Stress Disorders, Post-Traumatic	26	MDMA (Medium Dose MDMA (75 mg))	irdamyqsbf(jzetnqgwkp) = aprqpmhrgn kugqgsnrhz (ynnnqooavn, amoloqbfod - tiknlagolu) View more	-	02 Feb 2022
NCT01458327 (CTgov)	Phase 2	Stress Disorders, Post-Traumatic	3	3,4-methylenedoxymethamphetamine (MDMA)	sugjltuhow(jyslplafqx) = bjstsxnutz ssunckohpg (pdmhaywpeq, auekdemruk - iiwqxhkcgj) View more	-	03 Nov 2021
NCT00090064 (CTgov)	Phase 2	Stress Disorders, Post-Traumatic	23	Lactose placebo pill	cglarynefg(tzzkezcauh) = ihvixpfscy wleonuwwvv (qfqbdfxvhc, slmefovbsb - bbgctoplkx) View more	-	25 Oct 2021
NCT00402298 (CTgov)	Phase 2	Stress Disorders, Post-Traumatic	5	MDMA	cldvyhnpts(svhotiiiab) = gjpatobmzj qeclxqsxka (zjbrsmetwo, cuzqndqyih - nvmrpergcs) View more	-	20 Sep 2021

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