This study will assess the feasibility of administering ketamine plus midazolam or midazolam alone, when infused over 5 days in an outpatient setting, to adults with complex regional pain syndrome (CRPS).

Start Date01 Jan 2099

Sponsor / Collaborator

Stanford University

NCT07118215

/ Not yet recruitingPhase 1

A Phase 1, 3-part, Open-label Study to Evaluate the Effects of KarXT Administration on the Pharmacokinetics of Midazolam, Fexofenadine, and Digoxin in Healthy Adult Participants

The purpose of this study is to evaluate the effects of KarXT administration on the drug levels of midazolam, fexofenadine, and digoxin in healthy adult participants.

Start Date17 Sep 2025

Sponsor / Collaborator

Karuna Therapeutics, Inc.

NCT07095842

/ RecruitingPhase 2/3IIT

Efficacy of Add-on Ketamine With Second-dose Midazolam for Prehospital Treatment of Epileptic Children With Status Epilepticus

The goal of this pragmatic, decentralized, pre-consented, event-driven, randomized controlled trial is to investigate the efficacy of add-on ketamine to second-dose midazolam for prehospital treatment of epileptic children with convulsive status epilepticus.

Start Date03 Aug 2025

Sponsor / Collaborator

Sohag University

100 Clinical Results associated with Midazolam Hydrochloride

100 Translational Medicine associated with Midazolam Hydrochloride

100 Patents (Medical) associated with Midazolam Hydrochloride

7,605

Literatures (Medical) associated with Midazolam Hydrochloride

02 Sep 2025·INTERNATIONAL JOURNAL OF ENVIRONMENTAL ANALYTICAL CHEMISTRY

Development and application of a sustainable approach for the determination of 95 pharmaceutical substances and metabolites in urban wastewater by means of ultra-high-performance liquid-chromatography-tandem mass spectrometry

Author: Vincenti, Marco ; Gerace, Enrico ; Minella, Marco ; Privitera, Dana ; Massano, Marta ; Salomone, Alberto ; Alladio, Eugenio

In the last few years, the interest in pharmaceutical drugs and their metabolites as environmental pollutants is gaining growing importance.Regular monitoring and timely actions are decisive to implement appropriate water resource management strategies and to evaluate the efficiency of traditional or innovative wastewater treatment plants (WWTPs).This study describes the development and validation of an anal. procedure using 10 mL sample volume followed by direct-injection in ultra-high-performance liquid chromatog.-tandem mass spectrometry (UHPLC-MS/MS) for the simultaneous determination of 95 pharmaceutical drugs and 10 of their main metabolites in wastewater.Adequate sensitivity was recorded for all target analytes, with limits of detection below 5 ng/L for 60 out of 95 analytes and recoveries exceeding 80% for all the analytes under study.A total of 42 target analytes were detected in almost all sites, and limited differences were observed among several pharmaceutical drug arrays found at different sampling sites.In addition, an abatement yield higher than 50% was observed for only 12 of the 42 detected substances.The procedure, which combined direct injection and small sample volume collection, showed great potential and efficiency for the high-performance determination of pharmaceutical drugs in wastewater.

01 Sep 2025·BIOMATERIALS

Bioprinted high cell density liver model with improved hepatic metabolic functions

Article

Author: Feng, Gen-Sheng ; Meng-Saccoccio, Tobias ; Lu, Ting-Yu ; Xiang, Yi ; Chen, Shaochen ; Sun, Yazhi ; Shen, Erin Nicole ; Lyu, Cheng ; Ji, Yichun

In vitro liver tissue models are valuable for studying liver function, understanding liver diseases, and screening candidate drugs for toxicity and efficacy. While three-dimensional (3D) bioprinting shows promise in creating various types of functional tissues, current efforts to engineer a functional liver tissue face challenges in replicating native high cell density (HCD) and maintaining long-term cell viability. HCD is crucial for establishing the cell-cell interactions necessary to mimic the liver's metabolic and detoxification functions. However, HCD bioinks exacerbate light scattering in light-based 3D bioprinting. In this study, we incorporated iodixanol into our bioink formulation to minimize light scattering, enabling the fabrication of hepatic tissue constructs with an HCD of 8 × 10⁷ cells/mL while maintaining high cell viability (∼80 %). The printed dense hepatic tissue constructs showed enhanced cell-cell interactions, as evidenced by increased expression of E-cadherin and ZO-1. Furthermore, these constructs promoted albumin secretion, urea production, and P450 metabolic activity. Additionally, HCD hepatic tissue inactivated the YAP/TAZ pathway via cell-cell interactions, preserving primary hepatocyte functions. Further screening revealed that hepatocytes in the dense model were more sensitive to drug treatments than those in a lower-density hepatic model, highlighting the importance of HCD in recapitulating the physiological drug responses. Overall, our approach represents a significant advancement in liver tissue engineering, providing a promising platform for the development of physiologically relevant in vitro liver models for drug screening and toxicity testing.

01 Aug 2025·EPILEPSY RESEARCH

Adequate and inadequate dosing of anti-seizure medications in status epilepticus

Article

Author: Smith, Melissa ; Schrader, Susan

BACKGROUND:

Status epilepticus (SE) is defined as five or more minutes of continuous seizures or two or more discrete seizures with incomplete recovery of consciousness.¹ The incidence of SE in the United States ranges from 18.3 to 41 per 100,000 patients per year². Reviews of SE clinical literature demonstrate that 70-75 % of patients did not receive an adequate dose of benzodiazepine according to clinical guidelines. Underdosing of benzodiazepines increases the risk of refractory SE and unfavorable outcomes.^8-9 METHODS: This single center retrospective cohort study evaluated the dosing of benzodiazepines and other anti-seizure medications in adult patients with SE. The primary outcomes were incidence of breakthrough seizures in patients with appropriate dosing benzodiazepines compared to inappropriate dosing of benzodiazepines within 24 h of the first dose and incidence of breakthrough seizures in patients with appropriate loading dose of maintenance anti-seizure medication compared to inappropriate loading dose of anti-seizure medication within 24 h of the first dose.

RESULTS:

Thirty-eight patients received adequate benzodiazepine dosing compared to 155 with inadequate dosing. Eighty-seven percent of patients with adequate dosing of benzodiazepine experienced a breakthrough seizure compared to 84 % of patients with inadequate dosing (p = 0.62). Sixty-three percent of patients with adequate dosing of benzodiazepines required first non-benzodiazepine anti-seizure medication compared to 63 % of patients with inadequate dosing (p = 0.76). Breakthrough seizures within 24 h after the first load of non-benzodiazepine anti-seizure medication occurred in 21 % of patients in the adequate dosing group compared to 28 % in the inadequate dosing group (p = 0.73).

CONCLUSION:

While benzodiazepines and rescue anti-seizure medications are frequently underdosed in patients with status epilepticus, there was no difference in recurrent seizures comparted to those with adequate dosing.

News (Medical) associated with Midazolam Hydrochloride

14 Jul 2025

·www.globenewswire.com

Nuvectis Pharma Announces Successful Completion of a Drug-Drug Interaction Study in Healthy Volunteers Supporting NXP900's Potential as a Combination Partner with Leading Therapies

Drug-drug interaction (“DDI”) clinical studies help identify the potential for side effects, or in some cases, reduced therapeutic efficacy, that may be caused by interactions between different drugs. The market leading epidermal growth factor receptor (“EGFR”) and anaplastic lymphoma kinase (“ALK”) inhibitors for the treatment of non-small cell lung cancer (“NSCLC”) are substrates of the Cytochrome P450 (“CYP”) enzyme CYP3A, and therefore their combination with drugs that are strong inducers of CYP3A is to be avoided, or is contraindicated. As per the International Council for Harmonization (“ICH”) M12, topline results from the NXP900 DDI clinical study classify NXP900 as a weak inhibitor of CYP3A; these results support the combination strategy of NXP900 with EGFR/ALK Inhibitors in NSCLC and potentially additional combinations. July 08, 2025 -- Nuvectis Pharma, Inc. (NASDAQ: NVCT), a clinical stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, today announced the successful completion of a clinical DDI study in healthy volunteers for NXP900, supporting NXP900’s potential as a combination partner with leading therapies. Key Study Objective: To determine whether NXP900 is an inducer of CYP3A, and if so, to classify its induction as weak, moderate or strong as per ICH M12 guidelines Study Population: 14 healthy volunteers Key Pharmacokinetics Result: NXP900 increased the concentration of Midazolam, a known CYP3A sensitive substrate, by Key Safety Results: No serious or severe adverse events were reported in this study; diarrhea and non-infection related increases in white blood cell counts were the most common adverse events reported, all mild to moderate in intensity Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, “As we’re now completing the dose escalation Phase 1a study of NXP900 in patients with advanced cancers, the data generated to date, including the preclinical and mechanistic data, the clinical safety, pharmacokinetics and pharmacodynamics data, and now the clinical DDI data, strongly support advancing NXP900 into the Phase 1b program, set to begin in the coming weeks. In the Phase 1b we plan to test the therapeutic potential of NXP900 as a single agent and in non-chemotherapy based combinations with leading EGFR and ALK drugs in patients that may derive substantial clinical benefit from treatment with NXP900, as their cancers are expected to be sensitive to inhibition of SRC/YES1.” Mr. Bentsur concluded, “We believe that NXP900’s differentiating properties, mainly the type 1.5 mechanism of action which combines potent and selective inhibition of both the kinase activity and scaffolding properties of the SRC family kinases, should translate into a wide therapeutic window, and we are excited about the future of NXP900.” Nuvectis Pharma, Inc. is a biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology. The Company is currently developing two clinical-stage drug candidates, NXP800 and NXP900. NXP800 is an oral small molecule GCN2 activator currently in a Phase 1b clinical trial for the treatment for platinum resistant, ARID1a-mutated ovarian carcinoma and in an Investigator-sponsored clinical trial for the treatment of cholangiocarcinoma. NXP900 is an oral small molecule inhibitor of the SRC Family of Kinases (SFK), including SRC and YES1. NXP900's unique mechanism of action enables the inhibition of both the catalytic and scaffolding functions of the SRC kinase thereby providing complete shutdown of the signaling pathway. NXP900 is currently in a Phase 1a dose escalation study. The content above comes from the network. if any infringement, please contact us to modify.

Clinical Study

07 Jan 2025

·www.prnewswire.com

Neuraxpharm to further grow branded business with the acquisition of two leading narcolepsy treatments, Provigil® and Nuvigil®

Provigil® (modafinil) and Nuvigil® (armodafinil), two of the most trusted and widely prescribed brands in the narcolepsy category, will increase Neuraxpharm's global CNS presence and support market entry into new territories including Australia BARCELONA, Spain and DÜSSELDORF, Germany, Jan. 7, 2025 /PRNewswire/ -- Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, announces today that it has acquired at the end of December 2024 Provigil® (modafinil) and Nuvigil® (armodafinil), both of which are indicated for the treatment of Excessive Daytime Sleepiness (EDS) in adults with narcolepsy. Neuraxpharm has acquired these products in most markets outside the US^. Provigil's main market is Europe, with significant sales in France, Spain and Italy. Nuvigil is present in international markets with significant sales in Australia and Mexico. Both Provigil and Nuvigil are orally administered CNS stimulants indicated to improve wakefulness and reduce Excessive Daytime Sleepiness (EDS) in adult patients with narcolepsy, both with and without cataplexy. This acquisition is in line with Neuraxpharm's strategy to grow strong CNS brands and bring them to increasing numbers of patients worldwide. It will enable entry into new territories such as Australia, where Neuraxpharm also plans to launch first-in-class multiple sclerosis treatment ublituximab (BRIUMVI®), and will furthermore reinforce Neuraxpharm's presence in Mexico, where the Company established an office in 2023. The transaction follows the acquisition from Sanofi of two established product portfolios in 2023 and the securing of a landmark partnership with TG Therapeutics also in 2023 to commercialise ublituximab outside the US*. In 2020, Neuraxpharm acquired market-leading child epilepsy treatment Buccolam® (oromucosal midazolam) from Takeda, and in September last year Neuraxpharm received a positive CHMP opinion from the European Medicine Agency to extend Buccolam's indication to include the treatment of epilepsy in adults. Dr. Jörg-Thomas Dierks, CEO of Neuraxpharm, commented: "Today's acquisition is an example of how Neuraxpharm can harness its neurology-focused approach, broad international platform and entrepreneurial capabilities to expand strong CNS brands. These two leading narcolepsy treatments will be added to our broad and growing CNS portfolio. We will leverage our specialisation and reach to grow these products in existing and new markets, thereby bringing market-leading treatments to more CNS patients with unmet needs around the world." No financial details of the transaction have been disclosed. ^ Republic of Korea, Japan, Thailand and the United States are not included in this acquisition. * Territories outside the United States, Canada, Mexico, and excluding certain Asian countries previously partnered. About the Neuraxpharm Group Neuraxpharm is a leading European specialty pharmaceutical company focused on the treatment of the central nervous system (CNS), including both psychiatric and neurological disorders. It has a unique understanding of the CNS market built over 35 years. Neuraxpharm is constantly innovating, with new products and solutions to address unmet patient needs and is expanding its portfolio through its pipeline, partnerships, and acquisitions. The company has c.1,000 employees and develops and commercializes CNS products through a direct presence in more than 20 countries in Europe, two in Latin America, one in the Middle East, and globally via partners in more than 50 countries. Neuraxpharm is backed by funds advised by Permira. Neuraxpharm manufactures many of its pharmaceutical products at Neuraxpharm Pharmaceuticals (formerly Laboratorios Lesvi) in Spain. For more information, please visit SOURCE Neuraxpharm WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalAcquisitionClinical Result

07 Dec 2022

·www.prnewswire.com

Neuraxpharm expands into the Netherlands

The CNS specialist continues its strong expansion course in Europe and increases its presence from two to 20 countries in just six years NAARDEN, Netherlands and DÜSSELDORF, Germany, Dec. 7, 2022 /PRNewswire/ -- Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, announces the establishment of Neuraxpharm Netherlands. The expansion into the Dutch market allows Neuraxpharm to continue on its pathway to become the number one CNS specialist in Europe. Neuraxpharm Netherlands will provide differentiated and specialty generics in the Netherlands, a strategically important CNS pharmaceutical market in Europe. To date, Neuraxpharm Netherlands has launched two products: Dimethyl Fumarate to treat multiple sclerosis and Lacosamide, a product for the treatment of epileptic seizures. In addition, the company plans to launch Rivastagmin for treating dementia, which will become Neuraxpharm's third product in the Netherlands. The subsidiary will be run by Philipp Pohoralek as Country Manager for Neuraxpharm Netherlands, alongside his current role as Country Manager for Neuraxpharm Germany. As an experienced executive, Philipp will strive to strengthen the company's growth strategy in the Netherlands in line with his achievements in the important German market, which is the third largest CNS-market globally. Neuraxpharm Netherlands will conduct its operations from Naarden. Dr. Jörg-Thomas Dierks, CEO of Neuraxpharm, said: "By entering the Dutch market Neuraxpharm continues its strong growth momentum. We aim to become a leader in the Dutch CNS field, offering high value-added solutions to our stakeholders and patients. Our aim for 2023 is to further strengthen our portfolio pipeline in the Netherlands and to expand our dedicated team." Philipp Pohoralek, Country Manager of Neuraxpharm Netherlands, added: "We will leverage our CNS expertise to provide CNS patients, physicians, pharmacists and hospitals throughout the Netherlands with access to suitable products from our extensive portfolio thereby catering to the needs of patients in the region. We will furthermore provide a tailor-made entry out of more than 120 CNS molecules." Neuraxpharm is a European key player in the CNS market with a presence in more than 60 countries. With over 35 years of experience in the CNS field, the company has acquired a unique expertise in this market developing and commercializing established brands, value-added medicines, generics, Consumer Health products, medical cannabis, digital health solutions and orphan drugs. Neuraxpharm distributes its products through an extensive sales force in Europe. The company has a research hub and produces many of its products at its two production sites in Europe. In 2022, Neuraxpharm reached over 1000 employees. The recent market entry into the Netherlands follows a strong track-record. In the past few months Neuraxpharm has reached several milestones including entering the Greek CNS market and the steady expansion of its product offering through acquisitions, including two established product portfolios of branded business from Sanofi and prescription brand, Buccolam® (midazolam), in 2020, which is indicated for the emergency treatment of children and adolescents with epileptic seizures. In addition, Neuraxpharm has leveraged new business opportunities by entering the digital health and orphan drug markets through new licensing agreements with mjn-SERAS and Minoryx. Finally, the company has reinforced its position as a key player in the European medical cannabis market by creating a business unit dedicated to medical cannabis and expanding its collaboration with Panaxia, a global manufacturer of advanced medical cannabis products, into Switzerland and the Czech Republic. About the Group Neuraxpharm Neuraxpharm is a leading European specialty pharmaceutical company focused on the treatment of central nervous system disorders (CNS) with a direct presence in 20 countries. Backed by funds advised by Permira, Neuraxpharm has a unique understanding of the CNS market built over 35 years. With its focus on CNS, Neuraxpharm develops and commercializes established brands, value added medicines, generics, Consumer Healthcare products, medical cannabis, beyond-the-pill solutions (digital health and medical devices) and orphan drugs and is continuously striving to offer a wide range of effective, high quality and affordable CNS treatment options in Europe. Present with its products in more than 60 countries, Neuraxpharm also manufactures pharmaceutical products and active pharmaceutical ingredients in its own manufacturing sites, Lesvi and Inke, in Spain. For more information, please visit SOURCE Neuraxpharm

License out/inExecutive ChangeDrug ApprovalOrphan Drug

100 Deals associated with Midazolam Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D00696	Midazolam Hydrochloride	N05CD08	DB00683

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Status Epilepticus	United States	Meridian Medical Technologies LLC	14 Sep 2018
Seizures	European Union	Neuraxpharm Pharmaceuticals S.L.	04 Sep 2011
Seizures	Iceland	Neuraxpharm Pharmaceuticals S.L.	04 Sep 2011
Seizures	Liechtenstein	Neuraxpharm Pharmaceuticals S.L.	04 Sep 2011
Seizures	Norway	Neuraxpharm Pharmaceuticals S.L.	04 Sep 2011
Anesthesia	United States	Hoffmann-La Roche, Inc.	20 Dec 1985
Sedation	United States	Hoffmann-La Roche, Inc.	20 Dec 1985

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05610969 (CTgov)	Phase 1/2	Performance Anxiety \| Neurolytic Block \| Anxiety Disorders	36	Music (Music Group)	lkcbjvktgs(rfinytohuc) = eubwlnyrkn npmlwlmllo (awlgcxcard, 7.02) View more	-	14 May 2025
				Midazolam (Midazolam Group)	lkcbjvktgs(rfinytohuc) = rmgivmycnz npmlwlmllo (awlgcxcard, 9.22) View more
NCT04068948 (CTgov)	Phase 4	Sedation \| Dental Caries	37	Meperidine+Midazolam+Hydroxyzine (Midazolam, Hydroxyzine, Meperidine)	vydndueflu = ehfhtebpld iuqciykdsx (lcgzkpvzcw, qmxtgspygw - ckraswobbi) View more	-	05 Dec 2023
				Midazolam+Hydroxyzine (Midazolam, Hydroxyzine)	vydndueflu = ysnmhtyawb iuqciykdsx (lcgzkpvzcw, cppihyjlng - rgrwzsjlfz) View more
NCT02856698 (MIMO, CTgov)	Phase 4	Acute pulmonary edema	111	Midazolam (Midazolam)	mzspzyiiac = udigrefoyn obhbtmmhpx (veiqtyepol, hcvhcfkhtd - zqyozzgsam) View more	-	19 May 2022
				Morphine (Morphine)	mzspzyiiac = qpkqsjgulx obhbtmmhpx (veiqtyepol, eiisohvpty - kmjrcubbdk) View more
NCT03085563 (CTgov)	Phase 4	Abscess \| Sedation \| Lacerations	63	Nitrous Oxide (Nitrous Oxide)	ogypxqpvvp(enxqmtfnyf) = jsfxrrlqjs haealsazul (clzmmiibtq, cchdbplbps - fzenivqgbx) View more	-	10 May 2022
				Midazolam (Intranasal Midazolam)	ogypxqpvvp(enxqmtfnyf) = quzfbjoitw haealsazul (clzmmiibtq, mdvvemqrth - ksrkmajfmk) View more
NCT03336450 (CTgov)	Phase 3	Status Epilepticus	3	MHOS/SHP615	edeiodzpwc = uhniskbogt xivagqhqjd (esfqfeiesb, xceqcrteqr - pmunmvtovn) View more	-	14 Sep 2021
NCT02356705 (CTgov)	Phase 4	Sedation	42	saline placebo (Saline Placebo)	bxcfritsnu = cqqqwcjydu hbvfaqhwoc (oclbxmbaui, xnolfsdjec - gchbzoredk) View more	-	25 Feb 2021
				Midazolam (Nasal Midazolam Only)	bxcfritsnu = babkgarvrl hbvfaqhwoc (oclbxmbaui, mtqzunynfp - zvdamekdyn) View more
NCT02486328 (CTgov)	Phase 4	Gastrointestinal dysfunction \| Cognition	103	Meperidine+Midazolam (Group MM)	vkspiqppow(psvszueviq) = pbxkvbdiob bpjznczzwp (ylqcsejowu, 10.6) View more	-	03 Sep 2020
				Propofol+Remifentanil (Group RP)	vkspiqppow(psvszueviq) = pilsawyusj bpjznczzwp (ylqcsejowu, 6.8) View more
NCT03246724 (CTgov)	Phase 4	Sedation	327	Sodium chloride 0.9%+Microcrystalline Cellulose+Triazolam+Midazolam (Cataract Procedures)	sjmicytprn(ysztrddmos) = jfosatespz aidjssxypc (rwvbjsdzif, 0.57) View more	-	19 Aug 2020
				Sodium chloride 0.9%+Microcrystalline Cellulose+Triazolam+Midazolam (Retina Procedures)	sjmicytprn(ysztrddmos) = ctbctupahq aidjssxypc (rwvbjsdzif, 0.72) View more

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