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

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.

01 Jun 2024·Behavioural pharmacology

Activation of mGlu2/3 receptors with the orthosteric agonist LY-404,039 alleviates dyskinesia in experimental parkinsonism

Article

Author: Imane Frouni ; Woojin Kang ; Louis Desbiens ; Adjia Hamadjida ; Philippe Huot ; Cynthia Kwan

LY-404,039 is an orthosteric agonist at metabotropic glutamate 2 and 3 (mGlu2/3) receptors, with a possible additional agonist effect at dopamine D2 receptors. LY-404,039 and its pro-drug, LY-2140023, have previously been tested in clinical trials for psychiatric indications and could therefore be repurposed if they were shown to be efficacious in other conditions. We have recently demonstrated that the mGlu2/3 orthosteric agonist LY-354,740 alleviated L-3,4-dihydroxyphenylalanine (L-DOPA)-induced abnormal involuntary movements (AIMs) in the 6-hydroxydopamine (6-OHDA)-lesioned rat without hampering the anti-parkinsonian action of L-DOPA. Here, we seek to take advantage of a possible additional D2-agonist effect of LY-404,039 and see if an anti-parkinsonian benefit might be achieved in addition to the antidyskinetic effect of mGlu2/3 activation. To this end, we have administered LY-404,039 (vehicle, 0.1, 1 and 10 mg/kg) to 6-OHDA-lesioned rats, after which the severity of axial, limbs and oro-lingual (ALO) AIMs was assessed. The addition of LY-404,039 10 mg/kg to L-DOPA resulted in a significant reduction of ALO AIMs over 60–100 min (54%, P < 0.05). In addition, LY-404,039 significantly enhanced the antiparkinsonian effect of L-DOPA, assessed through the cylinder test (76%, P < 0.01). These results provide further evidence that mGlu2/3 orthosteric stimulation may alleviate dyskinesia in PD and, in the specific case of LY-404,039, a possible D2-agonist effect might also make it attractive to address motor fluctuations. Because LY-404,039 and its pro-drug have been administered to humans, they could possibly be advanced to Phase IIa trials rapidly for the treatment of motor complications in PD.

News (Medical) associated with Pomaglumetad methionil

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

13 Apr 2021

·www.biospace.com

Denovo's Licenses DB102 (Enzastaurin) for Rare Genetic Pediatric Onset Disorders to Aytu BioPharma

SAN DIEGO, April 13, 2021 /PRNewswire/ -- Denovo Biopharma LLC, a pioneer in applying precision medicine to development of innovative therapies, today announced that Aytu BioPharma has acquired substantially all the assets of Rumpus Therapeutics, including Rumpus' option to license DB102 for rare genetic pediatric onset or congenital disorders outside of oncology from Denovo Biopharma LLC. Furthermore, Aytu Biopharma has exercised this option so it now has an exclusive worldwide license from Denovo Biopharma LLC for these indications. Terms of the license were not disclosed. We are pleased that DB102 is generating value to Denovo prior to read-out of our pivotal clinical studies in oncology. Rumpus has focused its development of DB102 on vEDS. vEDS is a rare genetic disorder typically diagnosed in childhood and characterized by arterial aneurysm, dissection and rupture, bowel rupture and rupture of the gravid uterus. There are currently no U.S. Food and Drug Administration (FDA)-approved treatments for vEDS. Preclinical studies conducted by Dr. Hal Dietz, Professor of Genetic Medicine at Johns Hopkins University School of Medicine and an Investigator at the Howard Hughes Medical Institute have shown that PKC inhibition proved efficacious in multiple pre-clinical models and prevented death due to vascular rupture. Aytu BioPharma expects that this development program for DB102 will progress directly to a single pivotal study. "DB102 has the potential to treat a variety of disorders, both inside and outside of the oncology field. Rumpus Therapeutics has been actively pursuing development of DB102 in select rare genetic onset non-oncology indications, such as vEDS, since signing the option agreement, and we welcome the interest of Aytu BioPharma in accelerating these efforts," said Michael F. Haller, Ph.D., Denovo's Chief Business Officer. "As these indications are outside Denovo's core development areas for DB102 in DLBCL, GBM, and pulmonary arterial hypertension (PAH), this represents a validation of Denovo's business model of acquiring drugs for all indications and developing them with newly-discovered biomarkers in parallel with out-licensing non-core indications. We are pleased that DB102 is generating economic value to Denovo prior to read-out of our pivotal clinical studies in oncology." About vascular Ehlers-Danlos Syndrome (vEDS) Vascular Ehlers Danlos syndrome (vEDS) is the severe subtype of Ehlers-Danlos Syndrome, affecting 1 in 50,000 people worldwide and results from pathogenic variants in the COL3A1 gene, which encodes the chains of type III procollagen, a major protein in vessel walls and hollow organs. Twenty-five percent of vEDS patients have a first complication by the age of 20 years, and more than eighty percent have at least one complication by the age of 40. vEDS is a devastating condition, and vEDS patients have a median lifespan of 51 years. There are no FDA-approved therapies for vEDS. About DB102 DB102 (enzastaurin) is an orally available investigational first-in-class small molecule, serine/threonine kinase inhibitor of the PKC beta, PI3K, and AKT pathways that has been studied in more than 3,000 patients across a range of solid and hematological tumor types. DB102 was originally developed by Eli Lilly and for which Denovo has acquired worldwide rights. DB102 received Orphan Drug Designation in DLBCL and glioblastoma multiforme (GBM) from the FDA and EMA and Fast Track Designation from the FDA. 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 started a Phase 3 trial in Glioblastoma (GBM) for its lead product candidate, DB102 (enzastaurin), which was in-licensed from Eli Lilly. The company has six additional late-stage programs targeting major unmet needs: DB103 (pomaglumetad methionil) for schizophrenia, DB104 (liafensine) for depression, DB105 (formerly ORM-12741) for Alzheimer's Disease, DB106 (vosaroxin) for acute myeloid leukemia (AML), DB107 (formerly Toca 511 and Toca FC) for recurrent high grade glioma, and DB108 (endostatin) for non-small cell lung cancer (NSCLC). For additional information please visit . Contact: Michael F. Haller, Chief Business Officer Denovo Biopharma LLC mhaller@denovobiopharma.com

CollaborateOrphan DrugFirst in ClassSmall molecular drugFast Track

100 Deals associated with Pomaglumetad methionil

External Link

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D09949	-	-	-

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Schizophrenia	Phase 3	Japan	Eli Lilly & Co.	01 Jun 2010
Schizophrenia	Phase 3	Russia	Eli Lilly & Co.	01 Jun 2010
Schizophrenia	Phase 3	South Korea	Eli Lilly & Co.	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)	jelesogfvi(akrdwbmzbs) = xlfktgoyrp shrcrntewm (wixtdkymde, mkhdtfwomy - wdqjvskxnq) View more	-	03 Apr 2023
				Moxifloxacin (400 mg Moxifloxacin)	jelesogfvi(akrdwbmzbs) = uxpszvqius shrcrntewm (wixtdkymde, woqxfpmrcm - vmuzazcjjo) View more
NCT01307800 (CTgov)	Phase 3	Schizophrenia	567	LY2140023 (40 mg LY2140023, BID)	puhfrbjdqx(zuriluohmw) = cnphrjbbmq mygdmiwfce (ksstvyvjrt, 2.3) View more	-	18 Oct 2022
				LY2140023 (10 mg LY2140023, BID)	puhfrbjdqx(zuriluohmw) = bbwxnroggq mygdmiwfce (ksstvyvjrt, 2.0) View more
NCT01328093 (CTgov)	Phase 3	Schizophrenia	678	LY2140023 (LY2140023-DB)	qqsoagnvhc(xgqqznftkr) = dhjmcyvdup iboczbufpw (qjoopgehcg, 0.4) View more	-	07 Sep 2022
				Aripiprazole-DB (Aripiprazole-DB)	qqsoagnvhc(xgqqznftkr) = tenxxtcbfo iboczbufpw (qjoopgehcg, 0.6) View more
NCT00845026 (CTgov)	Phase 2	Schizophrenia	261	LY2140023 (LY2140023)	xofisqfqxl(wlqluqlngw) = wsadgnbupw qpfahsytux (jtkebytmxf, 5.95) View more	-	01 Sep 2022
				Olanzapine (Olanzapine)	ezhalgxkjy(yyspuxujfo) = clwlcmzqkm epumrwxhda (rylzrsvwkw, eydqddxytd - kczkakhaty) View more
NCT03321617 (CTgov)	Phase 1	Schizophrenia	16	Pomaglumetad methionil (POMA 40mg BID (80mg))	vecvwfoibv(ckrpnvnypo) = nfuowvvvzn nfjzsyheqy (bctnzdhmoa, .63605395) View more	-	01 Dec 2021
				Pomaglumetad methionil (POMA 80mg BID (160 mg))	vecvwfoibv(ckrpnvnypo) = lxstrvtgbt nfjzsyheqy (bctnzdhmoa, 0.1522939) View more
NCT01052103 (CTgov)	Phase 2	Schizophrenia	167	LY2140023 (LY2140023 + SOC)	pzkjfqedgz(oubfaepznr) = uspolsgtyv pkptsnbghp (sjhwxufswa, 1.2) View more	-	22 Sep 2021
				Placebo (Placebo + SOC)	pzkjfqedgz(oubfaepznr) = qkeriynusa pkptsnbghp (sjhwxufswa, 1.2) View more
NCT01475136 (CTgov)	Phase 1	Hepatic Insufficiency	37	LY2140023 (LY2140023-Normal Hepatic Function)	nnloxuyyby(okjmizhgil) = fwtnwcrghj cyprjojrio (zlywalqdkn, 34) View more	-	22 Sep 2021
				LY2140023 (LY2140023-Mild Hepatic Impairment)	nnloxuyyby(okjmizhgil) = ulcqkmlfyf cyprjojrio (zlywalqdkn, 30) View more
NCT01591330 (CTgov)	Phase 1	-	35	LY2140023 Reference form (LY2140023 Reference Form)	xdrmxtsfjj(dgrahsoprf) = rkqyzemtpq knqyrbnwdy (ngitmhbaaq, 25) View more	-	21 Sep 2021
				LY2140023 Test-Low (LY2140023 Test-Low)	xdrmxtsfjj(dgrahsoprf) = elpwvmjkiw knqyrbnwdy (ngitmhbaaq, 23) View more
NCT01609218 (CTgov)	Phase 1	-	27	LY2140023 (80 mg LY2140023)	ugofvfqzyl(mlggwhvklh) = alnbrzzotk otvnqenojz (guikiavpfk, 31) View more	-	21 Sep 2021
				Aqueous activated charcoal+LY2140023 (80 mg LY2140023 + 75 g Aqueous Activated Charcoal)	ugofvfqzyl(mlggwhvklh) = nrbnxbofei otvnqenojz (guikiavpfk, 25) View more
NCT01637142 (CTgov)	Phase 1	-	18	[14C]-LY2140023+LY2140023 (Oral 80 mg LY2140023 and IV LY2140023/[14C]-LY2140023)	xhxgyivupo(sfetbnvcpp) = hbzkxyqloy egmahhalkg (czohskrusd, 28) View more	-	21 Sep 2021
				[14C]-LY404039+LY404039+LY2140023 (Oral 80 mg LY2140023 and IV LY404039/[14C]-LY404039)	qnwuiichzk(adweynnvym) = elvmbwydmg hewbbmvjny (ppdfecmgqc, 27) View more

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