[Translation] A double-blind, randomized, placebo-controlled, phase Ib study to investigate the safety, tolerability, and pharmacokinetics of Pomaglumetad Methionil in Chinese patients with early schizophrenia

本研究的主要目的是评估 (a) 中国早期精神分裂症人群中递增剂量 pomaglumetad methionil 相较安慰剂的安全性和耐受性，以及 (b) 药代动力学。探索性目的是评估早期精神分裂症患者中 pomaglumetad methionil 相较安慰剂的初步疗效、药效学和药物遗传学。

[Translation]

The primary objectives of this study were to evaluate (a) the safety and tolerability of escalating doses of pomaglumetad methionil compared with placebo and (b) the pharmacokinetics in a Chinese population with early schizophrenia. The exploratory objectives were to evaluate the preliminary efficacy, pharmacodynamics, and pharmacogenetics of pomaglumetad methionil compared with placebo in patients with early schizophrenia.

Start Date21 Oct 2020

Sponsor / Collaborator

Eli Lilly & Co.

[+2]

NCT03321617

/ CompletedPhase 1IIT

Glutamate Reducing Interventions in Schizophrenia

Participants will be administered several doses of pomaglumetad (POMA) (low and high doses) over 14 days to individuals at clinical high risk for developing psychosis and use magnetic resonance imaging (MRI) brain imaging to determine whether these doses of POMA are affecting glutamate levels.

Start Date17 Apr 2018

Sponsor / Collaborator

The New York State Psychiatric Institute

[+1]

NCT03106571

/ TerminatedPhase 1IIT

Phase 1 Safety-interaction Study of Pomaglumetad Methionil for Methamphetamine Use Disorder

This is the first study of pomaglumetad in humans using methamphetamine. The goal of the study is to determine if pomaglumetad is safe when administered with methamphetamine. If shown to be safe with methamphetamine in the current study, a phase 2 clinical trial of pomaglumetad would be done to begin to find out if pomaglumetad is effective in treating methamphetamine use disorder.

Start Date01 Aug 2017

Sponsor / Collaborator

University of California, Los Angeles

[+1]

100 Clinical Results associated with Pomaglumetad methionil

100 Translational Medicine associated with Pomaglumetad methionil

100 Patents (Medical) associated with Pomaglumetad methionil

Literatures (Medical) associated with Pomaglumetad methionil

01 Apr 2026·JOURNAL OF PSYCHIATRIC RESEARCH

Unmet Promise or Missed Potential? A pairwise and network meta-analysis on efficacy and safety of metabotropic glutamate receptor agonists and positive allosteric modulators in schizophrenia

Review

Author: Mishra, Archana ; Maiti, Rituparna ; Mishra, Biswa Ranjan ; Srinivasan, Anand ; Shaju, Amiya ; Ibrahimpur, Nidhi Surendra

OBJECTIVE:

Metabotropic glutamate receptor(mGluR) agonists and allosteric modulators like pomaglumetad methionil(POMA) and AZD8529 offer a novel pharmacotherapeutic option in schizophrenia. The results of individual trials on these agents being inconclusive, this meta-analysis was planned to assess the safety and efficacy of mGluR modulators in schizophrenia.

METHODS:

Following PRISMA guidelines, a systematic search was performed on MEDLINE/PubMed, Embase, Web of Science, Scopus, Cochrane, Google Scholar and WHO-ICTRP, and randomized controlled trials(RCTs) that compared POMA or AZD8529 with either a placebo or second-generation antipsychotics(SGAs) were included. Change in PANSS-Total score was the primary outcome, and PANSS subscales, Clinical Global Impressions-Severity(CGI-S), treatment-emergent adverse events(TEAE) and discontinuation rates were secondary outcomes. A random-effects model was used to estimate the effect size for pairwise and network meta-analysis, and the risk of bias done by RoB2 tool.

RESULTS:

A total of ten RCTs (3715 participants) were included in the meta-analysis. mGluR modulators did not show significant improvement in PANSS-T (MD:3.20,95 %CI:0.64,5.76) or PANSS-subscales and CGI-S over the control group. The pooled odds ratio for TEAE (OR:1.08; 95 %CI:0.93,1.27) indicates a statistically nonsignificant incidence of adverse events in the experimental group. Discontinuation due to adverse events was higher in the experimental group (OR:1.43; 95 %CI:1.08,1.89), but discontinuation due to lack of efficacy was not significantly different between the groups (OR:1.24,95 %CI:0.86,1.77). Certainty of evidence ranged from high to low. None of the mGluR modulators were better than placebo or SGAs in network meta-analysis.

CONCLUSION:

mGluR modulators did not show efficacy in terms of improving symptom severity in schizophrenia. However, their therapeutic potential in specific subgroups may be explored by employing strategic trial designs and relevant biomarkers.

PROSPERO ID:

CRD420251066533.

01 Jul 2025·ACS Omega

Highly Sensitive Electrochemical Detection of Pomalidomide Using a Novel NiCuSe2/MnCoFe LTH Nanocomposite Sensor: Application to Real Sample Analysis

Article

Author: Hassan Elzain Hassan Ahmed ; Nevin Erk ; Wiem Bouali ; Asena Ayse Genc ; Mustafa Soylak

Abstract:

A novel electrochemical sensor for the quantification of Pomalidomide (POMA) is introduced in the present work, based on a glassy carbon electrode (GCE) modified with a unique NiCuSe2/MnCoFe layered triple hydroxide (LTH) composite. In this regard, the novel NiCuSe2/MnCoFe LTH composite was synthesized and characterized using various structural and morphological techniques, confirming its successful formation. The electrochemical properties of the composite were evaluated by cyclic voltammetry (CV) and electrochemical impedance spectroscopy (EIS), providing its high conductivity, superior electrocatalytic activity, and rapid electron transfer capabilities. The NiCuSe2/MnCoFe LTH-modified GCE was utilized for the detection and quantification of POMA using differential pulse voltammetry (DPV). The developed sensor exhibited an impressive linear detection range of 0.02–10.3 μM and an ultralow detection limit of 4.7 nM. Furthermore, it demonstrated exceptional selectivity, reproducibility, and repeatability. Finally, the sensor was applied to analyze POMA in some real samples: pharmaceutical capsules, human urine, and human blood serum.

01 Nov 2024·Journal of Stroke & Cerebrovascular Diseases

Minimal important difference of Berg Balance Scale, performance-oriented mobility assessment and dynamic gait index in chronic stroke survivors

Article

Author: Mohammadi, Faezeh ; Mazhar, Farid Najd ; Haji Alizadeh, Naeeme ; Heidari, Marzeih ; Taghizadeh, Ghorban ; Taghavi Azar Sharabiani, Parvaneh ; Jamali, Shamsi ; Goudarzi, Sepideh ; Foomani, Amir Sayyar Sabet ; Mehdizadeh, Maryam

OBJECTIVE:

The Berg Balance Scale (BBS), Performance-Oriented Mobility Assessment (POMA), and Dynamic Gait Index (DGI) are crucial standard tools used to evaluate functional balance. However, their minimal important difference (MID) threshold is yet to be established. The objective of this research was to explore the MID for BBS, POMA, and DGI in people suffering from chronic stroke.

METHODS:

A total of 130 chronic stroke patients were assessed using BBS, POMA and DGI before and after undergoing interventions. The treatment procedures included a series of task-oriented exercises focusing on motor re-learning. In anchor-based approach, the Clinical Global Impression of Improvement scale served as the anchor. The Receiver Operating Characteristic (ROC) curve was employed to identify the best MID cut-off point for BBS, POMA, and DGI. In the distribution-based approach, one-third standard deviation (SD), half SD, one standard error of measurement (SEM), and the total score of BBS, POMA and DGI were used to determine the MID.

RESULTS:

The MID from the ROC curve was greater than 2 points for BBS, greater than 1 point for POMA and DGI. For the distribution-based approach, the MIDs corresponding to one-third of the SD, half of the SD, and one SEM for BBS were 1.92, 3.20, and 0.90; for POMA were 1.47, 2.45, and 1.96; for DGI were 1.48, 2.47, and 1.16 points, respectively.

CONCLUSION:

BBS, POMA and DGI are suitable instruments for assessing functional balance in individuals with chronic stroke, with demonstrable MID. Additionally, the results indicated that DGI has higher sensitivity and specificity than the other examined scales for distinguishing between groups without change and those with minimal balance improvement after receiving interventions.

News (Medical) associated with Pomaglumetad methionil

09 Jun 2026

·alpheusmedical.com

Portfolio Spotlight: Alpheus Medical

This website uses cookies that help the website function and that help us understand how you interact with it. Please read our privacy policy for more information. Latest News Contact Us Request Funding Give About Portfolio Investment Strategy Venture Philanthropy Published on June 9, 2026 One of the things we look for in a BTIF portfolio company is a genuinely novel approach to treating brain tumors. Alpheus Medical is one of those companies. A Different Kind of Treatment Alpheus is developing a type of drug-led therapy it calls “Porphyrin Metabolite Activation” or, simply “PoMA.” The approach builds on the FDA-approved drug, 5-aminolevulinic acid (5-ALA) or “the pink drink,” which is already used to cause tumor cells to glow under fluorescent light during neurosurgery, helping surgeons better distinguish cancerous tissue from healthy tissue. Alpheus’s use of 5-ALA, however, is a potentially new application. The company has found that when the drug is given to a patient, it accumulates preferentially inside tumor cells as a metabolite. Alpheus then uses a novel ultrasound device to non-invasively send energy waves through the skull to activate the metabolite inside the cancerous cells. When activated, the metabolite triggers the release of what scientists call “reactive oxygen species” — highly unstable molecules that damage the internal structures of the tumor cells and cause them to destroy themselves. The body’s immune system then clears up the debris. The ultrasound itself is low-intensity and just serves as the trigger for the metabolite. What also makes this investigational approach appealing is that Alpheus hopes, if approved, the therapy could possibly prove more convenient for patients’ everyday lives. While patients still undergo standard-of-care surgery as part of their overall care, the PoMA treatment itself does not require additional surgical procedures, continuously wearable devices, or complex imaging or positioning systems. Patients take an oral drug and receive treatment while sitting in a chair, without the need for anesthesia or hospitalization. Because the approach is non-invasive and repeatable, it could offer a way to manage the disease over time with less onerous outpatient visits. Where Things Stand BTIF has participated in two rounds of funding for Alpheus. The initial investment supported an early clinical trial in patients with recurrent high-grade gliomas. In addition to demonstrating a favorable safety profile (meaning patients were able to receive the treatment without significant side effects), the study showed meaningful extension in patient survival compared to historical expectation, supporting continued development and evaluation of the therapy in larger trials. Those results allowed Alpheus to raise a $52 million Series B in May 2025 and launch a phase IIb randomized controlled trial in patients with newly diagnosed glioblastoma. In this study, all patients receive the current standard of care and the investigational group receives PoMA therapy in addition to that standard treatment. The goal is to determine whether adding PoMA can improve patient outcomes. Looking Ahead Alpheus is currently enrolling patients at multiple clinical sites across the United States. Patients and caregivers interested in learning more about the trial and eligibility can visit BrainCancerTrial.com. The Brain Tumor Investment Fund®, an affiliate of the National Brain Tumor Society, is a venture philanthropy fund supporting NBTS’s vision to conquer and cure brain tumors by investing in biotechnology, pharmaceutical, and medical device companies to catalyze new and novel treatments. FOLLOW US ON LINKEDIN Latest News Terms Privacy Copyright

Clinical ResultPhase 2

11 Feb 2026

·www.biospace.com

Denovo Biopharma Announces Partnership with Orygen on Phase 2 Study Evaluating DB103 (Pomaglumetad Methionil) in Treating Psychosis

SAN DIEGO, Feb. 11, 2026 (GLOBE NEWSWIRE) -- Denovo Biopharma LLC, a pioneer in applying precision medicine to development of innovative drugs, today announced a partnership with Orygen to initiate a Phase 2 investigator-initiated-trial (IIT) to study DB103 (pomaglumetad methionil) for first-episode psychosis (FEP) or clinical high risk (CHR) of psychosis. The study is being led by Professor Patrick McGorry, M.D., and sponsored by Orygen in Parkville, Australia. “Despite the introduction of antipsychotic medications over a decade ago, treatment options for a substantial minority of young patients with FEP or CHR of psychosis remain limited,” said Patrick McGorry, M.D., lead study investigator. “As a novel drug targeting the glutamate system, which plays a critical role in psychotic disorder, pomaglumetad presents an option to fulfill this unmet medical need. Given its excellent safety profile, it may be uniquely effective by addressing the shortcomings of other antipsychotics such as weight gain and prolactin elevation.” “Although pomaglumetad did not achieve statistically significant efficacy in a broad schizophrenia patient study, a subset of patients early in disease exhibited significantly greater improvement,” said Wen Luo, Ph.D., Denovo's Chief Executive Officer. “The study of pomaglumetad in patients with psychosis marks an important step forward in our mission to develop innovative and transformative therapies for psychiatric conditions. We are honored to work with the world-renowned team at Orygen, internationally recognized for its scientific leadership and extensive expertise in youth mental health research.” This open-label, Phase 2, feasibility trial will investigate the safety, tolerability, and acceptability of administering 2 daily doses of 40 mg of pomaglumetad methionil, over the duration of 12 weeks in young people aged 18-25 years with insufficient response to a single first-line antipsychotic treatment in FEP patients or failure of remission of CHR-positive symptoms and functional recovery in CHR patients. The study will also determine whether pomaglumetad can reduce total symptomatology and dysfunction. The study has been approved by the Royal Melbourne Hospital Human Research Ethics Committee (Project 2024.289). About DB103 (pomaglumetad methionil) Pomaglumetad methionil is a first-in-class psychiatric drug that selectively acts on the glutamic acid mGlu2/3 receptor and has no cross-reaction with other receptors in the central nervous system, and hence, can avoid some usual side effects of psychiatric drugs currently on the market. It was licensed from Eli Lilly (LLY), who had completed 37 clinical trials with more than 3,800 subjects. Pomaglumetad methionil has shown significant promise when applied to the right subpopulation of patients through personalized medicine or targeted therapy. About Denovo Biopharma Denovo Biopharma LLC is a clinical-stage biopharmaceutical company that uses novel biomarker approaches to execute efficient clinical trials in targeted patient subpopulations to increase the probability of success. Denovo has seven late-stage drugs in its pipeline addressing major unmet medical needs in central nervous system diseases and oncology, most of which are first-in-class drugs with global rights. A positive pivotal study of DB104 (liafensine) in patients with treatment-resistant depression who carry a Denovo-discovered novel ANK3 biomarker was recently published in JAMA Psychiatry. Visit for additional information. Investor Contact: Stephen Jasper Gilmartin Group stephen@gilmartinir.com

Phase 2

01 Jul 2021

·www.biospace.com

Denovo Biopharma In-Licenses Late-Stage Alzheimer's Disease Asset from Lundbeck

SAN DIEGO, July 1, 2021 /PRNewswire/ -- Denovo Biopharma LLC, a pioneer in applying precision medicine to develop innovative therapies, today announced it has licensed global rights for idalopirdine from H. Lundbeck A/S, including all rights to develop, manufacture and commercialize idalopirdine for all indications. Lundbeck received options to re-acquire idalopirdine for predetermined undisclosed financial terms, with Denovo and Lundbeck sharing China rights in the event Lundbeck's options are exercised and Denovo retaining all global rights in the event Lundbeck's options are not exercised. Terms of the agreement were not disclosed. Idalopirdine (now DB109) is an oral antagonist of the serotonin (5-HT6) receptor, which is primarily expressed in the brain and is hypothesized to be involved in Alzheimer's Disease, schizophrenia, and other indications. DB109 has been extensively evaluated in numerous clinical studies encompassing more than 2500 subjects. Although Phase 3 trial results were negative, subsets of patients who showed signs of beneficial activity of DB109 were identified. Despite the recent approval of aducanumab, Alzheimer's Disease remains one of the toughest diseases to conquer as countless drug have failed to demonstrate efficacy. While precision medicine has proved to vital to the many breakthroughs in oncology drug development in the last decade, the lack of pharmacogenomic biomarkers could be one of the main reasons of these failures in Alzheimer's Disease. Denovo plans to use its unique biomarker platform to search for pharmacogenomic predictors of DB109's efficacy. "Alzheimer's Disease remains an area of significant unmet need in neurological disease, and the rich idalopirdine data set that has been generated permits Denovo to fully leverage its experience in novel biomarker discovery to potentially identify patients for which idalopirdine may have benefit," said Michael F. Haller, Ph.D., Denovo's Chief Business Officer. "Denovo discovered the first known genetic biomarker for drug efficacy in a CNS disorder, for our DB104 asset in treatment-resistant depression, and we hope to have similar success for DB109." "We are excited to collaborate with Denovo Biopharma and build upon the efforts of our employees, investigators, and patients who participated in our clinical trials to potentially develop a personalized medicine for Alzheimer's Disease," said Keld Flintholm Jørgensen, CBO at Lundbeck. About Denovo Biopharma LLC Denovo Biopharma is a clinical-stage biopharmaceutical company that applies novel biomarker approaches to re-evaluate medicines that have failed in broad patient populations. The company seeks to discover genomic biomarkers correlated with patients' responses to drug candidates retrospectively. Denovo then designs and executes efficient clinical trials in targeted patient populations to optimize the probability of a successful trial. Denovo has completed enrollment of patients in the U.S. and China with diffuse large B-cell lymphoma (DLBCL) in a Phase 3 clinical trial and has an ongoing Phase 3 trial in Glioblastoma (GBM) for its lead product candidate, DB102 (enzastaurin), which was in-licensed from Eli Lilly & Co. The company has seven additional late-stage programs targeting major unmet needs: DB103 (pomaglumetad methionil) for schizophrenia, DB104 (liafensine) for depression, DB105 (ORM-12741) for Alzheimer's Disease, DB106 (vosaroxin) for acute myeloid leukemia (AML), DB107 (Toca 511 and Toca FC) for recurrent high grade glioma, DB108 (endostatin) for non-small cell lung cancer (NSCLC), and DB109 (idalopirdine) for Alzheimer's Disease. For additional information please visit . Contact: Michael F. Haller, Chief Business Officer Denovo Biopharma LLC mhaller@denovobiopharma.com

Collaborate

100 Deals associated with Pomaglumetad methionil

External Link

KEGG	Wiki	ATC	Drug Bank
D09949	-	-	-

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Schizophrenia	Phase 3	Japan	Denovo Biopharma LLC	01 Jun 2010
Schizophrenia	Phase 3	South Korea	Denovo Biopharma LLC	01 Jun 2010

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01606436 (CTgov)	Phase 1	Schizophrenia	86	LY2140023 (400 mg LY2140023)	plspvvvxox(xhfeitypdh) = eqkhqqcmdm caijbtavkp (lpebiixskj, lboiuebmsz - mojotuyclt) View more	-	03 Apr 2023
				Moxifloxacin (400 mg Moxifloxacin)	plspvvvxox(xhfeitypdh) = dxmsvfcvlm caijbtavkp (lpebiixskj, fgkqmnjtpz - gidfbmyhzg) View more
NCT01307800 (CTgov)	Phase 3	Schizophrenia	567	LY2140023 (40 mg LY2140023, BID)	rwabtxputl(hjbbtocdwc) = kanmiravtm angubgmcyd (zsyjxuqebd, 2.3) View more	-	18 Oct 2022
				LY2140023 (10 mg LY2140023, BID)	rwabtxputl(hjbbtocdwc) = ueoazrzija angubgmcyd (zsyjxuqebd, 2.0) View more
NCT01328093 (CTgov)	Phase 3	Schizophrenia	678	LY2140023 (LY2140023-DB)	nsbrpljjiv(qtjwtipqch) = ovpqsgfblk mwcnsjyozj (xdguoahazu, 0.4) View more	-	07 Sep 2022
				Aripiprazole-DB (Aripiprazole-DB)	nsbrpljjiv(qtjwtipqch) = pgiaczoqnq mwcnsjyozj (xdguoahazu, 0.6) View more
NCT00845026 (CTgov)	Phase 2	Schizophrenia	261	LY2140023 (LY2140023)	eqnflrvjcs(usossrtppw) = nvtnvduepk liotpkpqum (obixosirvy, 5.95) View more	-	01 Sep 2022
				Olanzapine (Olanzapine)	pqkhydctzq(spmovtgrkl) = yvnualinry vncqcotvvc (rlbuslccfr, ovtjgeyajp - splardbbbo) View more
NCT03321617 (CTgov)	Phase 1	Schizophrenia	16	Pomaglumetad methionil (POMA 40mg BID (80mg))	xwvxelgmjk(ehzpzsjgfq) = zhmhfjrywy bwtvyrtlwa (umcxyyfrqp, .63605395) View more	-	01 Dec 2021
				Pomaglumetad methionil (POMA 80mg BID (160 mg))	xwvxelgmjk(ehzpzsjgfq) = jqelnyzaaz bwtvyrtlwa (umcxyyfrqp, 0.1522939) View more
NCT01052103 (CTgov)	Phase 2	Schizophrenia	167	LY2140023 (LY2140023 + SOC)	ifewaampsy(fmbdmyjxhj) = zepvxdcoch ximxhqrskv (jwsptigiks, 1.2) View more	-	22 Sep 2021
				Placebo (Placebo + SOC)	ifewaampsy(fmbdmyjxhj) = oabhinemhk ximxhqrskv (jwsptigiks, 1.2) View more
NCT01475136 (CTgov)	Phase 1	Hepatic Insufficiency	37	LY2140023 (LY2140023-Normal Hepatic Function)	pwkuocglzh(hmiktlcfjx) = alijcexgdh nuwifcxjdz (osyunwduoq, 34) View more	-	22 Sep 2021
				LY2140023 (LY2140023-Mild Hepatic Impairment)	pwkuocglzh(hmiktlcfjx) = sulbsjgcpp nuwifcxjdz (osyunwduoq, 30) View more
NCT01609218 (CTgov)	Phase 1	-	27	LY2140023 (80 mg LY2140023)	aombeddjwu(sjurvgjphk) = psjfqmowou phszkahgct (jcoklizuwb, 31) View more	-	21 Sep 2021
				Aqueous activated charcoal+LY2140023 (80 mg LY2140023 + 75 g Aqueous Activated Charcoal)	aombeddjwu(sjurvgjphk) = oyqdjgwsve phszkahgct (jcoklizuwb, 25) View more
NCT01591330 (CTgov)	Phase 1	-	35	LY2140023 Reference form (LY2140023 Reference Form)	nxapzroses(akcnqmhtir) = ayexcfavhy orgbjhjpty (uodaypvdap, 25) View more	-	21 Sep 2021
				LY2140023 Test-Low (LY2140023 Test-Low)	nxapzroses(akcnqmhtir) = ujvdlsimau orgbjhjpty (uodaypvdap, 23) View more
NCT01637142 (CTgov)	Phase 1	-	18	[14C]-LY2140023+LY2140023 (Oral 80 mg LY2140023 and IV LY2140023/[14C]-LY2140023)	zqtavifrkk(rbepnkbqyg) = eoahwihquz lifctsqnsl (iwobtnrtls, 28) View more	-	21 Sep 2021
				[14C]-LY404039+LY404039+LY2140023 (Oral 80 mg LY2140023 and IV LY404039/[14C]-LY404039)	jzdvkzfsun(pmyxeyoyno) = igigdxxyfx xcipdkuica (eloiqnlsrl, 27) View more

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