A Randomized, Double-blind, Placebo-controlled Trial to Evaluate Multiple Dose Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Ascending Doses of Noribogaine in Healthy Volunteers.

This trial will be a randomised, double-blind, sequential-group, multiple-dose, placebo-controlled, dose escalation trial to characterise the pharmacokinetics (PK), pharmacodynamics (PD) and safety of noribogaine in healthy adult participants.

开始日期2024-06-20

申办/合作机构

DemeRx, Inc.

ACTRN12613001064796

/ Completed临床1期

A Phase 1B, Single Center, Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Noribogaine in Opioid Dependent Participants Seeking to Discontinue Methadone Opioid Substitution Treatment (OST)

开始日期2013-10-14

申办/合作机构

DemeRx, Inc.

ACTRN12613000539730

/ CompletedN/A

Evaluation of Instruments and Procedures Used to Measure Opioid Withdrawal in Opioid Dependent Participants Who are Seeking to Discontinue Methadone Opioid Substitution Treatment (OST)

开始日期2013-07-30

申办/合作机构

DemeRx, Inc.

100 项与 Noribogaine Hydrochloride 相关的临床结果

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100 项与 Noribogaine Hydrochloride 相关的转化医学

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100 项与 Noribogaine Hydrochloride 相关的专利（医药）

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项与 Noribogaine Hydrochloride 相关的文献（医药）

2026-01-14·Journal of the American Chemical Society

Deciphering Ibogaine’s Matrix Pharmacology: Multiple Transporter Modulation at Serotonin Synapses

Article

作者: Lankri, David ; Shern, Tyler P. ; Serrano, Inis C. ; Sulzer, David ; Havel, Václav ; Mendieta, Adriana M. ; Sun, Steven ; Walther, Donna ; Sonders, Mark S. ; He, Keer ; Ma, Boxuan ; Baumann, Michael H. ; Westergaard, Xavier ; Selinger, Tim Luca ; Rodriguez, Luisina ; Hwu, Christopher ; Sames, Dalibor ; Goodman, Hannah J. ; Hwu, Jennifer ; González, Bruno ; Carrera, Ignacio ; Liu, Rose ; Wu, Hunter

Ibogaine is the main psychoactive alkaloid produced by the iboga tree (Tabernanthe iboga) that has a unique therapeutic potential across multiple indications, including opioid dependence, substance use disorders, depression, anxiety, posttraumatic stress disorder (PTSD), and traumatic brain injury (TBI). We systematically examined the effects of ibogaine, its main metabolite noribogaine, and a series of iboga analogs at monoamine neurotransmitter transporters, some of which have been linked to the therapeutic effects of these substances. We report that ibogaine and noribogaine inhibit the transport function of the vesicular monoamine transporter 2 (VMAT2) with submicromolar potency in cell-based fluorometry assays and at individual synaptic vesicle clusters in mouse brain as demonstrated via two-photon microscopy. Examining the uptake and release of radiolabeled serotonin in isolated brain synaptic vesicles, we confirmed that ibogaine and noribogaine act as inhibitors of VMAT2 and showed that noribogaine induces partial serotonin release from synaptic vesicles. Noribogaine does not compete with the binding of dihydrotetrabenazine, an established VMAT2 inhibitor, indicating that noribogaine engages the VMAT2 transporter at a distinct binding site or conformational state. The iboga compounds also inhibit the plasma membrane monoamine transporters (MATs), prominently including the serotonin transporter (SERT), and a novel iboga target, the organic cation transporter 2 (OCT2). SERT transport inhibition was demonstrated in serotonin axons and somata in mouse brain slices and in rat brain synaptosomes, where ibogaine and its analogs did not act as substrate-type serotonin releasers. Noribogaine, oxa-noribogaine, and several analogs displayed dual inhibition of VMAT2 and SERT with comparable potencies, a relatively uncommon activity in the pharmacopoeia of monoamine transporter inhibitors, and were hence labeled as "Synaptic Reuptake Inhibitors" ("SynRIs"). The SynRI profile provides an explanatory model for previously reported neurochemical effects of ibogaine in rodents. Together, the updated profile of the monoamine transporter modulation offers insight into the grand complexity of the iboga pharmacology, which we termed "matrix pharmacology". The matrix pharmacology hypothesis is outlined and used to conceptualize why ibogaine and noribogaine do not induce catalepsy, as demonstrated in our study, in contrast to other VMAT2 inhibitors.

2025-10-01·Progress in Neuro-Psychopharmacology

Psychedelic-induced behavioral and developmental effects on zebrafish: a systematic review

Review

作者: Hallak, Jaime E C ; Dos Santos, Rafael G ; de Oliveira, Danielle P ; de Oliveira, Arthur L

Psychedelics are mind-altering substances that have shown promising effects in the treatment of neuropsychiatric disorders owing to their antidepressant, anxiolytic and antiaddictive effects. However, data on their developmental toxicity is scarce, which might hinder its therapeutic suitability, and preclinical data on their behavioral effects is mainly restricted to rodents. In this context, zebrafish emerge as vertebrate model, since it shows well conserved genetic, neurodevelopment, molecular and physiological pathways that are comparable to humans. Additionally, high fecundity, clear embryo visualization, fast development and good nervous system homology make it an interesting model in assessing developmental toxicity and behavior. Thus, we conducted a systematic review of the articles which evaluated these parameters after psychedelic exposure. Thirteen articles were included of which nine focused on adult behavioral alterations and four on developmental toxicity. Substances used included ayahuasca, dimethyltryptamine (DMT), ibogaine, lysergic acid diethylamide (LSD), methylenedioxymethamphetamine (MDMA), mescaline, noribogaine, psilocybin and psilocin. Overall, psychedelics did not elicit morphological abnormalities in embryo-larvae, although ayahuasca induced edemas and increased mortality at high concentrations. Ibogaine, MDMA and LSD were associated with locomotor impairments after exposure during development. DMT, psilocybin and psilocin elicited an anxiolytic effect on larvae, while LSD, MDMA, mescaline and noribogaine reduced anxiety in adult fish. Altogether, psychedelics present a safe toxicological profile at low concentrations in zebrafish, but it is yet unclear whether they induce offspring's neurodevelopment deficits. Further studies are warranted to elucidate the extent of these adverse effects and if they persist during development.

2025-09-03·ACS Chemical Neuroscience

Pharmacological Evaluation of Tropane Analogues at the Serotonin Transporter

Article

作者: Olson, David E. ; Warren, Hunter T. ; Senthil, Abinaya ; Avanes, Arabo A.

Tropane alkaloids and their derivatives represent a diverse class of small molecules with a broad range of therapeutic applications. Many tropanes regulate synaptic levels of neuromodulators by interacting with monoamine transporters such as dopamine (DAT) and serotonin (SERT) transporters. While DAT inhibition plays an important role in the addictive potential of tropanes such as cocaine, recent evidence suggests that SERT modulation may oppose the effects of DAT inhibition. Moreover, SERT modulators such as 3,4-methylenedioxymethamphetamine (MDMA), ibogaine, and selective-serotonin reuptake inhibitors (SSRIs) have demonstrated potential as treatments for a broad range of conditions, including depression, addiction, and post-traumatic stress disorder (PTSD). Here, we profiled a variety of structurally distinct subclasses of tropanes in SERT inhibition, efflux, and pharmacochaperone assays. We identified several compounds capable of potently modulating SERT in ways similar to those of fluoxetine, MDMA, or noribogaine. In particular, UCD0168 and UCD0820 emerged as potent SERT inhibitors that act as full and partial serotonin releasing agents (SRAs) in SERT-transfected HEK293T cells, respectively. Our work demonstrates that it is possible to use the tropane scaffold as a starting point for identifying both MDMA-like and noribogaine-like SERT modulators, and we provide several new tropane-containing hit structures for creating optimized therapeutics relying on SERT modulation.

项与 Noribogaine Hydrochloride 相关的新闻（医药）

2026-04-29

·GlobeNewswire-Health Care

Silo Pharma’s PTSD Program Advances as FDA Fast-Tracks Psychedelic Therapies for PTSD

Federal initiatives focused on PTSD and related conditions appears to validate need for new and novel approaches to mental health treatment SARASOTA, Fla, April 29, 2026 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (NASDAQ: SILO), a developmental-stage biopharmaceutical company focused on novel therapeutics and drug delivery systems, today commends a wave of coordinated U.S. federal actions that are rapidly advancing the development of psychedelic-based therapeutics for mental health and substance use disorders. Building on last weekend’s executive initiative to fast-track these treatments, multiple agencies have taken meaningful steps this week to accelerate research, clinical progress, and regulatory clarity across the sector. The Advanced Research Projects Agency for Health announced initial awardees under its EVIDENT program, including leading institutions such as Johns Hopkins University and other innovators focused on psychedelic science. Silo believes this funding validates its position on the growing importance of data-driven approaches to treating complex neurological and psychiatric conditions. In parallel, the U.S. Food and Drug Administration granted investigational new drug (IND) clearance to DemeRx NB for its noribogaine candidate targeting alcohol use disorder, highlighting continued expansion of clinical-stage programs in the mental health space. “We are witnessing a coordinated and accelerating shift at the federal level,” said Silo CEO Eric Weisblum. “From funding and clinical advancement to regulatory prioritization, in our opinion the foundation is being laid for a new generation of therapies that could transform how we treat PTSD and related disorders.” The FDA issued three Commissioner’s National Priority Vouchers to Compass Pathways, Usona Institute, and Transcend Therapeutics, underscoring a clear intent to accelerate high-impact therapies. Notably, the inclusion of a PTSD-relevant program further signals a strong institutional focus on addressing urgent unmet needs among veterans and broader patient populations. Additionally, the organization confirmed that final guidance for psychedelic drug development will be published imminently, a long-anticipated milestone expected to provide critical clarity for sponsors and researchers navigating clinical and regulatory pathways. About Silo Pharma, Inc. Silo Pharma is a diversified developmental-stage biopharmaceutical and cryptocurrency treasury company. Its therapeutic focus is on addressing underserved conditions, including stress-induced psychiatric disorders, chronic pain, and central nervous system (CNS) diseases. The Company’s portfolio includes innovative programs such as SPC-15 for PTSD, SP-26 for fibromyalgia and chronic pain, and preclinical assets targeting Alzheimer’s disease. Silo’s research is conducted in collaboration with leading universities and laboratories. silopharma.com Forward Looking Statements This news release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified using words “could”, “believe”, “anticipate”, “intend”, “estimate”, “expect”, “may”, “continue”, “predict”, “potential”, and similar expressions that are intended to identify forward-looking statements. Such statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of the Company to differ materially from the results expressed or implied by such statements, including statements about the intended use of proceeds from the offering, changes to anticipated sources of revenues, future economic and competitive conditions, difficulties in developing the Company’s technology platforms, retaining and expanding the Company’s customer base, fluctuations in consumer spending on the Company’s products and other factors. Accordingly, although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company disclaims any obligations to publicly update or release any revisions to the forward-looking information contained in this press release, whether as a result of new information, future events, or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events except as required by law. Contact (800) 705-0120investors@silopharma.com

临床申请

2026-04-24

·FierceBiotech

Compass, Usona and Transcend score FDA national priority vouchers amid Trump administration’s psychedelic push

The therapies focus on treatment-resistant depression, major depressive disorder and post-traumatic stress disorder.\n The FDA is awarding national priority vouchers to Compass Pathways, Transcend Therapeutics and the Usona Institute as the Trump administration looks for ways to support advances in psychedelic medicine. Just days after President Donald Trump’s executive order focused on accelerating access to mental health treatments, the FDA has announced a series of regulatory actions, including the issuance of three national priority vouchers to companies studying psychedelic treatments for mental health disorders.The vouchers are meant to accelerate research, approval, and access to these treatments, according to an April 24 release from the FDA. Psychedelic medicines boast therapeutic potential in areas such as treatment-resistant depression, alcoholism, major depressive disorder and post-traumatic stress disorder, FDA commissioner Marty Makary, M.D., said in the release.In this batch of Commissioner\'s National Priority Vouchers (CNPVs), the agency is placing a spotlight on psilocybin as a potential answer for treatment-resistant depression (TRD) and major depressive disorder (MDD), as well as methylone for post-traumatic stress disorder (PTSD).Companies included in the voucher program are entitled to benefits such as improved communication with the FDA and a shorter 1- to 2-month reviews after filing an application for approval.In a release earlier today, London-based Compass Pathways announced that the FDA granted its rolling review request and selected COMP360, the company’s proprietary formulation of synthetic psilocybin, for the CNPV program.In a phase 3 trial that included more than 1,000 participants, Compass says that patients with TRD experienced effects within a day of treatment that lasted at least six months for those who achieved a clinically meaningful response. In a statement, Compass CEO Kabir Nath called the voucher “a clear validation of both the urgent unmet need facing millions of people living with treatment resistant depression and the innovative science of COMP360.”Nonprofit Usona Institute also confirmed to Fierce Biotech that it has also been awarded a CNPV by the FDA for its psilocybin treatment for patients with major depressive disorder. Usona’s psilocybin program previously received an FDA breakthrough designation in 2019. Its psilocybin treatment, PSIL201, is now in phase 3.Additionally, Transcend Therapeutics confirmed to Fierce that it was a voucher recipient. It had previously received a breakthrough designation for its methylone PTSD treatment, TSND-201. The candidate met its primary endpoint in a phase 2 study last July that showed significant improvement for patients on the Clinician-Administered PTSD Scale. In addition to the vouchers, the FDA is also allowing an early-phase clinical study of noribogaine hydrochloride to move forward following an Investigational New Drug submission by DemeRx NB. Noribogaine hydrochloride is the principal psychoactive metabolite of the oneirogen ibogaine, which is derived from an African shrub. It will be the first time the FDA has allowed a clinical study in the U.S. of a derivative of ibogaine. The FDA follows the state of Texas’ announcement last month that it would be conducting a $50 million state-sponsored study of ibogaine after it couldn’t find a biopharma company to help run the study.FDA Commissioner Marty Makary, M.D., said the regulatory changes are aimed at addressing the nation’s mental health crisis. “As this field moves forward, it is critical that their development is grounded in sound science and rigorous clinical evidence. We owe it to our nation’s veterans and all Americans who are suffering from these conditions to evaluate these potential therapies with urgency,” he said in a statement.

临床3期临床结果优先审批突破性疗法临床2期

2026-04-24

·Firstwordpharma

Compass snags priority voucher as FDA begins rolling review of its psychedelic

Moving quickly under President Donald Trump's executive order, the FDA on Friday awarded three Commissioner's National Priority Vouchers (CNPVs) to companies developing psychedelic therapies for mental health disorders. Compass Pathways was one such recipient, with its candidate – a synthetic formulation of psilocybin called COMP360 – holding a Breakthrough Therapy designation for treatment-resistant depression (TRD). The US regulator also granted the drugmaker's rolling NDA submission and review request for COMP360, whose marketing application in TRD includes data from a pair of Phase III trials that met their primary endpoint. With the CNPV in-hand, Compass may now benefit from a one to two month review of its psilocybin-based treatment. "Importantly, while the CNPV may provide process efficiencies and accelerated review timelines, an NDA submission must still meet FDA’s established standards of clinical evidence, scientific rigor, and regulatory compliance," Compass CEO Kabir Nath said in a statement. "We are confident we meet these standards."Psychedelic potential While the FDA didn't name the other two CNPV recipients, one was awarded to a company developing a psilocybin-based agent for major depressive disorder (MDD). A possible recipient is Helus Pharma, whose deuterated psilocybin analogue HLP003 is in Phase III testing for MDD and has received Breakthrough Therapy designation for the adjunctive treatment of the mood disorder.The third voucher went to a firm developing methylone — a synthetic stimulant structurally similar to MDMA — for post-traumatic stress disorder (PTSD). The recipient here may be Transcend Therapeutics and its neuroplastogen, TSND-201. The candidate, a formulation of methylone designed to be non-hallucinogenic, has Breakthrough Therapy status for PTSD (see – Spotlight On: Neuroplastogens hit the mainstream in 2024. What's next for trip-less psychedelics?).Transcend started a Phase III PTSD trial of TSND-201 this month, according to ClinicalTrials.gov. The company is in the process of being bought by Otsuka Pharmaceutical in a deal worth up to $1.2 billion. Helus and Transcend did not immediately respond to requests for comment.Guidance incomingThe FDA also gave a boost to an earlier-stage psychedelic. This week, the agency cleared DemeRx to begin a Phase I trial of DMX-1001 (oral noribogaine) to treat alcohol-use disorder (AUD). The company expects to launch a Phase II study next year.The neuroplastogen is a derivative of ibogaine, a psychoactive indole alkaloid derived from the African Tabernanthe iboga shrub. According to DemeRx, DMX-1001 is designed to reverse the effects of AUD and lower the risk of relapse by promoting long-lasting neural connections through neuroplasticity and normalising neurotransmitter signalling.To support further psychedelic development, the US regulator said it will "imminently" release final guidance on how to design and conduct an adequate and well-controlled study evaluating a serotonin-2A agonist. The report will also feature recommendations on data collection and generation, as well as patient monitoring.

临床3期临床1期突破性疗法优先审批

100 项与 Noribogaine Hydrochloride 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
阿片相关性障碍	临床2期	美国	DemeRx, Inc.	2022-01-30
物质滥用	临床1期	英国	DemeRx, Inc.	2024-06-20
酒精使用障碍	临床申请批准	美国	DemeRx NB, Inc.	2026-04-29

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06480981 (CTgov)	临床1期	-	55	Noribogaine (Noribogaine 20mg)	餘夢築膚築積衊簾鬱鏇(簾鹽衊顧蓋糧繭鬱衊糧) = 築獵網簾鬱繭餘鬱築廠糧蓋構壓餘夢齋築窪醖 (範獵蓋製壓襯艱鹹選鏇, 3.26) 更多	-	2026-01-22
NCT06480981 (CTgov)	临床1期	-	55	Noribogaine (Noribogaine 40mg)	餘夢築膚築積衊簾鬱鏇(簾鹽衊顧蓋糧繭鬱衊糧) = 獵繭顧餘範壓鹹鹹膚顧糧蓋構壓餘夢齋築窪醖 (範獵蓋製壓襯艱鹹選鏇, 8.47) 更多	-	2026-01-22
NCT06480981 (BusinessWire) 人工标引	临床1期	酒精使用障碍	55	DMX-1001	艱築鏇網齋齋遞鹹構衊(膚獵醖遞鹹襯簾願醖鑰) = safe and well-tolerated 窪顧獵蓋廠觸繭鏇鹹廠 (壓選簾鬱顧觸窪築積鏇 )	积极	2026-01-06