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Last update 23 Jan 2025

Clonazepam

Last update 23 Jan 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryKLONOPIN (clonazepam) is a benzodiazepine medication that was first approved by the FDA in 1975 for the treatment of seizure disorders and panic disorder. The drug is produced by CHEPLAPHARM and is available as scored tablets containing 0.5 mg of clonazepam, and unscored tablets containing 1 mg or 2 mg of clonazepam. Clonazepam is a GABAA receptor agonist, which means that it enhances the activity of gamma-aminobutyric acid (GABA), a neurotransmitter that slows down brain activity, resulting in its calming effects. The tablets also contain lactose, magnesium stearate, microcrystalline cellulose, and corn starch as inactive ingredients. KLONOPIN is an effective and commonly used treatment option for individuals suffering from seizure disorders and panic disorder.

Drug Type

Small molecule drug

Synonyms

1,3-dihydro-7-nitro-5-(2-chlorophenyl)-2H-1,4.benzodiazepin-2-one, 5-(2-chloro-phenyl)-7-nitro-1,3-dihydro-benzo[e][1,4]diazepin-2-one, 5-(2-chlorophenyl)-7-nitro-1H-benzo[e][1,4]diazepin-2(3H)-one

+ [15]

Target

GABAA receptor

Mechanism

GABAA receptor agonists(Gamma-aminobutyric acid A receptor agonists)

Therapeutic Areas

Nervous System DiseasesOther Diseases

Active Indication

EpilepsyPanic Disorder

Inactive Indication-

Originator Organization

F. Hoffmann-La Roche Ltd.

Active Organization

CHEPLAPHARM Arzneimittel GmbH

Jiangsu Nhwa-Sede Pharm. Co., Ltd.Taiyo Pharma Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

US (04 Jun 1975),

EpilepsyPanic Disorder

RegulationOrphan Drug (US)

Structure/Sequence

Molecular FormulaC15H10ClN3O3

InChIKeyDGBIGWXXNGSACT-UHFFFAOYSA-N

CAS Registry1622-61-3

Clinical Trials associated with Clonazepam

NCT06611202

/ Not yet recruitingNot Applicable

Enhancing Mobility and Mental Health in Dementia Patients: A Multidisciplinary Six-Minute Walking Group Pilot Study

This study aims to evaluate the effect of a multidisciplinary six-minute walking group and activities on patients with dementia's physical activity levels, mobility, anxiety, and cognitive function. The primary objective of this study is to evaluate the effectiveness of a multidisciplinary six-minute walking group intervention-spearheaded by physiotherapists, occupational therapists, and psychologists-in enhancing physical activity, mobility, cognitive function, and functional independence among patients with dementia. A systematic review of existing evidence on the effectiveness of the existing interventions will be conducted to contextualise the findings, providing a robust benchmark for assessing the contribution of each therapeutic component.
Secondary Objectives:
1. Physiotherapy Impact: To determine the specific effects of physiotherapy on mobility, endurance, and balance in dementia patients using validated, objective measures.
2. Occupational Therapy Contribution: To evaluate the role of occupational therapy in improving functional independence and the ability to perform daily activities through targeted, task-oriented activities.
3. Psychological Impact: To assess the psychological benefits of the intervention, including reductions in anxiety and enhancements in mood and overall mental health, as a result of the psychologist-led component.
4. Dietary Support Role: To investigate the influence of integrated dietary support on physical activity levels, nutritional status, and overall health.
5. Feasibility and Scalability: To explore the practicality of integrating this multidisciplinary intervention into routine dementia care and assess its potential for broader application across similar settings.

Start Date06 Jan 2025

Sponsor / Collaborator

Oxleas NHS Foundation Trust

CTRI/2024/08/072081

/ Not yet recruitingNot ApplicableIIT

A Randomized Control Trial on effectiveness of Clonazepam Versus Nitrazepam after failure of Steroids and Vigabatrin in Infantile Epileptic Spasm Syndrome. - Nil

Start Date16 Aug 2024

Sponsor / Collaborator-

NCT06133114

/ RecruitingPhase 4IIT

Psychopharmacological Treatment of Emotional Distress: A Randomized Controlled Trial

This is an inpatient four-arm randomized control trial comparing single drug clonazepam (S arm), a two-drug combination clonazepam/olanzapine (D arm), and a three-drug combination clonazepam/olanzapine/buprenorphine (T arm) with treatment as usual (TAU arm) in the treatment of emotional distress, specifically the Suicide Crisis Syndrome (SCS). All participants in experimental arms receive 2-day pulse treatments targeting four out of five of the acute emotional distress symptoms. The primary outcome measure is SCS at discharge and one-month follow-up. The secondary outcome measures include questions about suicidal behaviors associated with emotional distress at a one-month follow-up.

Start Date13 Mar 2024

Sponsor / Collaborator

Icahn School of Medicine at Mount Sinai

100 Clinical Results associated with Clonazepam

100 Translational Medicine associated with Clonazepam

100 Patents (Medical) associated with Clonazepam

4,432

Literatures (Medical) associated with Clonazepam

01 Mar 2025·Journal of Hazardous Materials

Environmental exposure to common pesticide induces synaptic deficit and social memory impairment driven by neurodevelopmental vulnerability of hippocampal parvalbumin interneurons

Article

Author: Laezza, Fernanda ; Green, Thomas A ; Matz, Lisa M ; Avchalumov, Yosef ; Marosi, Mate ; Koff, Leandra ; Buffington, Shelly A ; Di Re, Jessica ; Ameredes, Bill T ; Singh, Aditya K ; Seeley, Erin H ; Baumgartner, Timothy J ; Hallberg, Lance M

Environmental exposure to pesticides at levels deemed safe by regulatory agencies has been linked to increased risk for neurodevelopmental disorders. Yet, the mechanisms linking exposure to these disorders remain unclear. Here, we show that maternal exposure to the pesticide deltamethrin (DM) at the no observed adverse effect level (NOAEL) disrupts long-term potentiation (LTP) in the hippocampus of adult male offspring three months after exposure, a phenotype absent in female offspring. Clonazepam, a GABAa receptor agonist, rescued this deficit, indicating impaired hippocampal GABAergic signaling. Recordings from CA1 pyramidal neurons, complemented by MALDI mass spectrometry imaging, showed an imbalance in excitatory/inhibitory tone. Using a combination of parvalbumin (PV)-Cre transgenic mice and hippocampal injection of designer receptors exclusively activated by designer drugs (DREADDs), we show that developmental DM exposure reduces hippocampal PV interneuron intrinsic firing. DREADD activation rescued both PV interneuron firing and LTP deficits. Complementary behavioral experiments revealed a deficit in social memory, a behavior relevant to autism spectrum disorder (ASD) symptomatology, which was restored by DREADD activation. Overall, these results establish a novel mechanistic link between maternal exposure to DM at the NOAEL and known cellular, circuital, and behavioral vulnerabilities, indicating it is a potential driver in the exposome of ASD.

11 Feb 2025·Neurology

Risk of Adverse Pregnancy Outcomes Associated With Antiseizure Medications and Their Indications

Review

Author: Perucca, Piero ; Kuhn, Raphael ; Perucca, Emilio ; Berry-Noronha, Alexander ; Chen, Zhibin ; Vajda, Frank J. ; McGuiness, Georgia ; Rottler, Alanna ; Manoleehakul, Pamada ; Antonic-Baker, Ana

BACKGROUND AND OBJECTIVESAside from congenital malformations and impaired postnatal neurodevelopment, risks associated with antiseizure medication (ASM) use during pregnancy have been sparsely investigated, particularly outside of epilepsy. We aimed to assess these risks through a systematic literature review and meta-analysis, including ASM exposure for any indication.METHODSWe searched MEDLINE, EMBASE, and Cochrane for studies including pregnant women on ASMs for any indication and untreated pregnant women, investigating obstetric complications and fetal/neonatal complications other than congenital malformations and impaired neurodevelopment. Differences in outcomes between groups were estimated using odds ratios (ORs) with 95% CIs.RESULTSOf 20,416 references identified, 75 studies amassing 16,941,373 pregnancies or live births (14,437,221 pregnancies with maternal outcome data and 14,938,972 live births with fetal/neonatal outcome data) were included. Forty-nine studies had low risk of bias, and 26 had medium risk. Compared with pregnancies in unaffected women (women without the conditions indicating prescription of ASMs), those exposed to ASMs had increased odds of several adverse outcomes including preterm birth (OR 1.30, 95% CI 1.09-1.54), cesarean section (OR 1.43, 95% CI 1.13-1.81), gestational diabetes (OR 1.44, 95% CI 1.07-1.94), induction of labor (OR 1.46, 95% CI 1.15-1.86), preeclampsia (OR 1.33, 95% CI 1.02-1.72), spontaneous miscarriage (OR 1.42, 95% CI 1.01-2.01), and spontaneous fetal loss (OR 2.54, 95% CI 1.04-6.24). Comparison of outcomes between untreated women with the same ASM indications and unaffected women showed that some differences (preterm birth, cesarean section, gestational diabetes, and preeclampsia) were largely attributable to the underlying condition, particularly epilepsy. The odds of spontaneous miscarriage, spontaneous fetal loss, elective cesarean section, 5-minute APGAR score <7, and admission to the neonatal intensive care unit were significantly greater in ASM-exposed than in unexposed pregnancies in women with the same indications, but the possible confounding effect of between-group differences in disease severity could not be assessed. The odds of small-for-gestational age differed across ASMs, with signals pointing to an association with clonazepam, oxcarbazepine, topiramate, and zonisamide.DISCUSSIONPregnancies exposed to ASMs are at increased risk of numerous obstetrical and perinatal complications. Although some of these adverse outcomes are attributable to the underlying condition, particularly epilepsy, exposure to ASMs seems to be associated with additional risks. These findings can be incorporated into routine patient counseling.

15 Jan 2025·The Journal of Maternal-Fetal & Neonatal Medicine

Use of antiepileptic drugs by trimester

Article

Author: Benson, Rachael J. ; Pack, Alison M. ; Wright, Jason D. ; Huang, Yongmei ; Logue, Teresa C. ; D’Alton, Mary E. ; Friedman, Alexander M.

OBJECTIVETo determine which antiepileptic drugs pregnant women receive by trimester.METHODSThis retrospective cohort study using the IBM Watson Health MarketScan Research Databases evaluated which antiepileptic drugs pregnant women with epilepsy received by trimester. Women with aged 15-54 years with a history of seizure disorder who underwent a delivery hospitalization between 2008 and 2017 were included in the analysis. Descriptive statistics were performed.RESULTSOf 34,144 women with a seizure disorder diagnosis and a delivery hospitalization, 10,289 (30.1%) received an anti-epileptic medication during pregnancy of which more than half received lamotrigine or levetiracetam. Other antiepileptic medications used by >5% of the population during any one trimester in the study period included carbamazepine, clonazepam, and topiramate. In evaluating medication use in the 1st trimester versus the 2nd trimester, clonazepam use decreased 32.0% (95% CI 60.0%, 77.0%) from 5.6% to 3.8% of patients receiving antiepileptics from the 1st to the 2nd trimester, gabapentin deceased 22.1% (95% CI 0.68%, 0.90%) from 4.1% to 3.2%, and topiramate decreased 30.0% (95% CI 62.8%, 77.9%) from 7.2% to 5.1%. In comparison, levetiracetam increased from 22.5% to 33.3% between the 1st and 3rd trimester and lamotrigine 22.2% to 27.5% between the 1st and 3rd trimester, 48.3% and 24.0% increases respectively.CONCLUSIONAntiepileptic drugs with less favorable fetal risk profiles such as topiramate decreased by trimester while medications with more favorable fetal risk profiles such as lamotrigine and levetiracetam increased. These findings broadly support that there are opportunities to improve pre-conceptional counseling of women with epilepsy.

News (Medical) associated with Clonazepam

18 Nov 2024

·www.prnewswire.com

Endo Expands Voluntary Recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) Due to Potential Product Carton Strength Mislabeling

MALVERN, Pa., Nov. 18, 2024 /PRNewswire/ -- Endo, Inc. (OTCQX: NDOI) ("Endo") announced today that one of its operating subsidiaries, Endo USA, Inc., is expanding its previously announced voluntary recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) due to potential product carton strength mislabeling. Continue Reading Carton front and blister pack Carton side Specifically, Endo's ongoing investigation has identified the possibility that the Clonazepam product lots listed below contain a limited number of cartons printed with the incorrect strength and National Drug Code (NDC) code due to an error by a third-party packager. The blister strips and tablets inside the product pack reflect the correct strength for the lot. The following table details the lots being added to the voluntary recall, including lot product description and NDC number. Risk Statement: Children and adults who inadvertently consume a higher dose of clonazepam could be at increased risk for the adverse events of significant sedation, confusion, dizziness, diminished reflexes, ataxia, and hypotonia. There is reasonable probability for significant, possibly life-threatening, respiratory depression especially for patients with concomitant pulmonary disease, patients who have prescribed dosing near maximal dosing, and patients also taking other medications that could cause additional respiratory depression. To date, Endo has not received any reports of adverse events associated with this product recall. Clonazepam Orally Disintegrating Tablets are indicated alone or as an adjunct in the treatment of the Lennoz-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. Additionally, the product is indicated for the treatment of panic disorder. Package Identification: The product is packaged in cartons containing 60 tablets packed into 10 blister strips each containing 6 tablets. The carton and each blister strip pocket are printed with the name, strength, lot number, expiration date, and NDC number. The packaging lists the legacy company Par Pharmaceutical which previously marketed clonazepam before the product was acquired by Endo. The images below provide an example of the potential mislabeling showing the components of a package of Clonazepam Orally Disintegrating tablets, USP 2 mg lot 550176501 with a carton bearing the product description and NDC code of Clonazepam Orally Disintegrating Tablets, USP 1 mg 60-count. The location of the lot number on each component of the package is shown on the photographs within this release. Action Required: The product lots were distributed through wholesale distributors to retail pharmacies nationwide. Endo is providing written notification to wholesale accounts and retailers that have received the product lots and is arranging for the return of all existing inventory through Inmar, Inc. Distributors, retailers that have the product lot being recalled should immediately stop distributing and dispensing and return to the place of purchase or contact Inmar on the below telephone line. Consumers in possession of any unused prescribed tablet cartons of Clonazepam Orally Disintegrating tablets, USP bearing the above lot numbers have been advised to discontinue use of the product. In the event that a patient inadvertently took an incorrect dose rather than the intended dose, they are advised to consult a physician. Consumers with questions regarding this recall can contact Inmar by telephone at 855-589- 1869 (Monday through Friday, 9 a.m. to 5 p.m. ET) or by email at [email protected]. For more information about Clonazepam Orally Disintegrating Tablets, USP, please see full Prescribing Information including BOXED WARNING available at DailyMed - CLONAZEPAM tablet, orally disintegrating (nih.gov). Adverse reactions or quality problems experienced with the use of this product lot may be reported to the U.S. Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program: Online: Mail: use postage-paid, pre-addressed Form FDA 3500 available at Fax: 1-800-FDA-0178 This product lot recall is being made with the FDA's knowledge. About Endo Endo is a diversified pharmaceutical company boldly transforming insights into life- enhancing therapies. Our passionate team members collaborate to develop and deliver these essential medicines. Together, we are committed to helping everyone we serve live their best life. Learn more at or connect with us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements including but not limited to any statements related to product recalls, mislabeling, adverse events, FDA or other regulatory actions and any other statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "guidance," "future," "potential" or similar expressions are forward-looking statements. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, they involve risks and uncertainties, some of which Endo may not currently be able to predict. Although Endo believes that these forward-looking statements and other information are based upon reasonable assumptions and expectations, readers should not place undue reliance on these or any other forward-looking statements and information. Actual results may differ materially and adversely from current expectations based on a number of risks, uncertainties and factors, including risks and uncertainties related to the recall and any future recalls, potential adverse events and any regulatory actions by the FDA. Endo assumes no obligation to publicly update any forward- looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws. Additional information concerning risk factors, including those referenced above, can be found in press releases issued by Endo and in Endo's public filings with the U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Endo's most recent Form 10-Q and in Endo's final prospectus filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, in connection with its Form S-1/A. SOURCE Endo, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

18 Oct 2024

·www.prnewswire.com

Introducing Clear Behavioral Health's 15th Location for Addiction Recovery and Mental Health Treatment

Gardena's Premier Destination for Residential, In-Network Treatment GARDENA, Calif., Oct. 17, 2024 /PRNewswire/ -- The vibrant city of Gardena has welcomed an exciting addition to its wellness community with the grand opening of Clear Behavioral Health Residential Rehab Treatment Center. As Clear's 15th location within Los Angeles County, this comprehensive behavioral health facility will serve Gardena, the South Bay, and surrounding areas by providing a residential rehab and detox facility for addiction recovery and dual diagnosis treatment. Continue Reading Step inside Clear Behavioral Health's Residential Rehab Treatment Center in Gardena, CA. Serving Los Angeles County and surrounding areas by providing a residential rehab and detox facility for addiction recovery and dual diagnosis treatment. At this new 20 bed facility, clinicians treat a wide variety of substance use disorders and mental health conditions, including Alcohol/Opiate/Stimulant Use Disorder, Benzodiazepine dependence, dual diagnosis addiction w/ depression, anxiety, trauma, ADHD Staggering statistics forecast that only 28% of eligible Detox/Rehab/RTC individuals, and a mere 11% of eligible PHP/IOP individuals, will receive treatment in 2026. Clear's new facility aims to bridge that gap for those in need of care. The new location expands Clear's treatment capacity by 20 beds, enabling more individuals to receive comprehensive, evidence-based treatment that most major insurance providers cover. At this new Gardena facility, clinicians treat a wide variety of substance use disorders and mental health conditions, including Alcohol Use Disorder, Opiate Use Disorder (heroin, fentanyl, kratom, pain killers), Stimulant Use Disorder (methamphetamine, Adderall, crack/cocaine), Benzodiazepine dependence (Xanax, Klonopin), dual diagnosis disorders including addiction with depression, anxiety, trauma, ADHD, and other mental health diagnoses. Our highly individualized treatment plans are tailored to meet each client's needs at every step of their recovery journey. Dr. Martha B. Koo, MD, Chief Medical Officer and Clinical Supervisor of Clear Behavioral Health, brings unparalleled expertise and passion to addressing mental health solutions through Clear's services. Dr. Koo obtained her psychiatry residency training at the Resnick Neuropsychiatric Institute at UCLA and her subsequent psychoanalytic training at the New Center for Psychoanalysis. She is double Board-Certified in Psychiatry and Addiction Medicine and has over twenty years of psychiatric experience. "Our services at Clear Behavioral Health are designed to be highly individualized, evidence-based, and holistic, ensuring that each client receives care tailored to their unique needs," said Dr. Martha Koo. "We believe in treating the whole person—addressing not just the symptoms of mental health and addiction disorders but also the underlying issues. Our compassionate and experienced staff create a warm, welcoming environment that fosters healing and recovery, empowering individuals to reclaim their lives." Joining Dr. Koo's team as the Clinical Director of Clear's Substance Use Disorder Division is Jason Bernstein, LMFT. Jason holds a master's degree in clinical psychology from Antioch University. With over five years of experience in the substance use and mental health field, he is passionate about supporting individuals seeking dual diagnosis treatment on their journey toward healing, growth, and achieving emotional and psychological wellbeing. His commitment to providing compassionate care and fostering an environment conducive to recovery positions him as a valuable leader for the Gardena facility. "Our inpatient rehab provides the safety and comfort needed for individuals to detox and rehabilitate from addiction while also addressing underlying mental health disorders," said Jason Bernstein. "We are excited to welcome our first clients to Gardena, where we're proud to provide whole-person family-centered care. Every person deserves the opportunity to recover, grow, and live a functional, happy life." The Gardena facility features a home-like, safe, and clinical environment. Program Director Jamie Arthur, CATC, CADC-II, has over 10 years of experience in the substance use recovery field and is dedicated to ensuring clients receive a robust range of program services to launch their recovery. Services include: Round-the-Clock Clinical Staff: Our compassionate team led by Jason Giles, MD, and Brittany Skinner, PMHNP provides 24/7 supervised care. Peer Support: Group therapy sessions foster a sense of unity while providing the space to develop healthy relationships. Medication Management: Safe transitions into detox help patients regain mental and physical stability as comfortably as possible. Therapy and Counseling: Individual therapy and counseling help patients uncover the root of their mental health struggles and develop tools to regain self-trust and balance. Experiential Therapies: Group therapeutic wellness activities such as yoga, meditation and sound healing enhance recovery. In addition to the Gardena launch, Clear Behavioral Health has recently opened facilities in Van Nuys and El Segundo, providing outpatient mental health treatments for adults and teens. These locations offer Intensive Outpatient Programs (IOP), including individual therapy, peer support, holistic therapies, and academic counseling. Founded in 2015, Clear Behavioral Health is a subsidiary of Your Behavioral Health, a leading regional provider of mental health and addiction treatment services for adults and teens, with 28 facilities and growing throughout Southern California. Your Behavioral Health provides the full continuum of behavioral health care, including detox, outpatient (PHP/IOP), interventional psychiatry, and residential care across its family of brands — which includes Clear Behavioral Health, New Life House, and Neuro Wellness Spa — and delivers specialized programs for depression, anxiety, trauma-related issues, addiction and other mental health conditions. Co-founders Mike Joly, Chief Executive Officer, and Dr. Martha Koo, Chief Medical Officer, lead Your Behavioral Health alongside an expert team of clinicians across Southern California. For more information about Clear Behavioral Health or to schedule a free consultation, please visit our website at or call us at 877-564-5571. About Clear Behavioral Health ClClear Behavioral Health, formerly Clear Recovery Center, is a leading Los Angeles-based provider of comprehensive, in-network behavioral health treatment programs. Our mission is simple: to help those struggling with mental health and addiction live healthy and purposeful lives. Our unique story started with a vision to make clinically excellent, highly individualized mental health services accessible to all. For a list of our 15 locations, visit . About Your Behavioral Health Your Behavioral Health is a leading regional behavioral health services platform providing comprehensive, best-in-class services for adults and teens across the continuum of mental health and addiction treatment. With state-of-the-art facilities across Southern California, expert clinical teams, and a pioneering evidence-based approach, Your Behavioral Health offers specialized residential, inpatient, and outpatient programs for a range of mental health conditions. Its family of brands includes Clear Behavioral Health, New Life House, and Neuro Wellness Spa. For more information, please visit . Contact: Stephanie Paz Townsend (310) 295-0429 [email protected] SOURCE Clear Behavioral Health WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

15 Aug 2024

·www.fiercepharma.com

B. Braun, Baxter launch separate recalls over particulate concerns and excess endotoxin levels, respectively

So far this year, drugmakers have been forced to yank their products over labeling issues, potency issues, contamination scares and more. So far in August, the FDA has announced two separate drug recalls on its website: one related to particulate concerns and the other thanks to high endotoxin levels.While neither recall has resulted in any safety flags or side effect reports so far, the issues stemming from the faulty products could be severe, the drugmakers have warned.First up, German drug and devicemaker B. Braun Medical is yanking two lots of injectable 0.9% sodium chloride to the consumer level in the U.S. The company blamed the product pull on the potential for particulate matter and fluid leakage from the product’s “E3 containers.” The solution is used in both kids and adults as a source of electrolytes and water for hydration. The product is specifically approved for extracellular fluid replacement, treatment of metabolic alkalosis with fluid loss and mild sodium depletion. The product is also used as a priming solution for hemodialysis procedures and may be used to kick-start and terminate blood transfusions without hemolyzing red blood cells.The German firm says it mistakenly released the affected batches to domestic distributors across the U.S. before completing required acceptance activities for embedded particulate matter.While the company hadn’t received any safety reports as of Aug. 8, there is a risk of patients suffering embolic issues like stroke or ischemia/infarction to other organs, plus possible infection, if the particulates in the product aren’t sterile, B. Braun warned.Separately, Baxter International is voluntarily withdrawing a single lot of heparin sodium in 0.9% sodium chloride injection due to the potential for elevated endotoxin levels.The injection is used as an anticoagulant to maintain catheter patency—or the state of being open or unobstructed. Baxter says it shipped the suspect batch to U.S. healthcare facilities, wholesalers and distributors between March 12 and Aug. 24.Using heparin with excess endotoxin levels could lead to serious health consequences for patients such as toxic shock, organ failure and death, the company warned.As of Aug. 6, the company hadn’t received any adverse event reports tied to the product pull.Over the last year, drugmakers have been forced to yank their products over labeling issues, potency issues, contamination scares and more. Most recently, Endo USA—a unit of Endo Pharmaceuticals—recalled a single lot of clonazepam tablets in July thanks to a labeling issue that resulted in an incorrect strength being printed on the product cartons.Endo blamed the issue on a third-party packager.As for the risk of particulate matter turning up in drugs, Pfizer’s Hospira in October recalled three lots of sodium bicarbonate and lidocaine HCI injectables due to the possible presence of glass particles in vials.

Drug Approval

100 Deals associated with Clonazepam

External Link

KEGG	Wiki	ATC	Drug Bank
D00280	Clonazepam	N03AE01	DB01068

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Epilepsy	US	CHEPLAPHARM Arzneimittel GmbH	04 Jun 1975
Panic Disorder	US	CHEPLAPHARM Arzneimittel GmbH	04 Jun 1975

Clinical Result

Indication

Phase

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02913924 (CTgov)	Phase 2	Marijuana Abuse	68	Clonazepam (Clonazepam)	shkscixecu(sbilyynyub) = mmunqvdbbs wwwarrzkym (magykeuqos, vakuspniie - gsiwakyknz) View more	-	06 Aug 2021
				Placebo (Placebo)	shkscixecu(sbilyynyub) = qgurnszsnd wwwarrzkym (magykeuqos, guyifrivwr - lhiokphhjm) View more
WCN2019	Not Applicable	REM Sleep Behavior Disorder First line	40	Prolonged-release melatonin 2mg	chmtyfnhko(flrynvkfli) = kjkibvvhpe rbzwudwoan (uwqkglwvly )	-	15 Oct 2019
				Clonazepam 0.5mg	chmtyfnhko(flrynvkfli) = sbpsalbvcr rbzwudwoan (uwqkglwvly )
WSC2019	Not Applicable	Somnambulism	2	OROS-MPH 18 mg/day	xctikfxsrt(fsxuyopyni) = telinnkbpz yojgqqaqmm (hqqhlepsdj )	Positive	20 Sep 2019
				OROS-MPH 36 mg/day	xctikfxsrt(fsxuyopyni) = ngvvnaclno yojgqqaqmm (hqqhlepsdj )
MDS2018	Not Applicable	REM Sleep Behavior Disorder	40	Clonazepam	(ziwzrpbjrw) = nduppcyhjp ladslxwrvh (bpfitdpopt )	Negative	05 Oct 2018
				Placebo	(ziwzrpbjrw) = jbwtbkmvas ladslxwrvh (bpfitdpopt )
ANA2016	Not Applicable	Primary Orthostatic Tremor	2	Clonazepam	(qwyqijifbo) = xqjkyyhbzv qclfgngymu (lrnvvmsjdn )	Positive	14 Oct 2016
EAN2015	Not Applicable	Status Epilepticus First line	177	Clonazepam	yxexbadrle(fqrznwhutt): OR = 4.35 (95% CI, 1.8 - 10.49) View more	Positive	29 Jun 2015
				Lorazepam
AAN2015	Not Applicable	Epilepsy	-	Clobazam	yfwyymbxws(jskfonnloq) = bilafemjpo tafzpucsie (xqqvhcnrrk ) View more	-	06 Apr 2015
				Clonazepam	yfwyymbxws(jskfonnloq) = fmuzzxnepc tafzpucsie (xqqvhcnrrk ) View more
NCT00594945 (CTgov)	Phase 2	Seizures \| Epilepsy	45	Clonazepam (Intranasal Clonazepam 2 mg)	nhjsthfdbt(gmltpbjlyq) = magunoquhb pykeccckei (zqoycealxd, cisczeyqmt - eyxpeyvxzz) View more	-	01 Jul 2014
				Clonazepam (Intranasal Clonazepam 3 mg)	nhjsthfdbt(gmltpbjlyq) = zeqkiiasdx pykeccckei (zqoycealxd, lnkcevyffu - hqobpwyzxq) View more
NCT02852577 (Pubmed \| J Clin Psychopharmacol)	Phase 4	Panic Disorder	120	Clonazepam	(nxamehlnxq) = lluflfltjs slcfqzlrzx (pyjsbnafoj )	-	01 Feb 2012
				Paroxetine	(nxamehlnxq) = vwiiyjnfnh slcfqzlrzx (pyjsbnafoj )
NCT02852577 (Pubmed \| Braz J Med Biol Res)	Phase 4	Panic Disorder	120	Clonazepam	jbgadtimxq(yevnhztfmu) = Patients treated with clonazepam had fewer adverse events than patients treated with paroxetine (73 vs 95%) ozsseomgxg (tvmbhbcbpt )	-	01 Apr 2011
				Paroxetine

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Clonazepam

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R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation