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Last update 20 Apr 2025

Atomoxetine Hydrochloride

Last update 20 Apr 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryAtomoxetine, a diminutive molecule drug concocted by Eli Lilly, procured its inaugural medical approval in 2002. The drug functions as an inhibitor of norepinephrine reuptake in the brain, inducing augmented levels of norepinephrine in the synaptic cleft. The drug's primary indication is for Attention Deficit Disorder with Hyperactivity (ADHD), a disorder typified by inattentiveness, impulsivity, and hyperactivity. Atomoxetine is postulated to operate by enhancing focus and concentration in individuals grappling with ADHD. Taking everything into account, atomoxetine's intricate mechanism of action and clinical indications proffer it as a valuable therapeutic option for those affected by ADHD.

Drug Type

Small molecule drug

Synonyms

(-)-Tomoxetine, Atomoxetine, Atomoxetine hydrochloride (JAN/USP)

+ [9]

Target

NET

Action

inhibitors

Mechanism

NET inhibitors(Norepinephrine transporter inhibitors)

Therapeutic Areas

Other Diseases

Active Indication

Attention Deficit Disorder With Hyperactivity

Inactive Indication

Alzheimer DiseaseAttention Deficit and Disruptive Behavior DisordersAttention Deficit Disorder+ [9]

Originator Organization

Eli Lilly & Co.

Active Organization

Eli Lilly Australia Pty Ltd.Lilly SA

Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.

+ [1]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

United States (26 Nov 2002),

Attention Deficit Disorder With Hyperactivity

RegulationOrphan Drug (United States), Priority Review (China)

Structure/Sequence

Molecular FormulaC17H22ClNO

InChIKeyLUCXVPAZUDVVBT-UNTBIKODSA-N

CAS Registry82248-59-7

241

Clinical Trials associated with Atomoxetine Hydrochloride

NCT06573970

/ Not yet recruitingPhase 4IIT

Atomoxetine Effect on Attention, Executive Function, and Quality of Life in Veterans With Posttraumatic Stress Disorder

Attention deficits (AD) frequently co-occur with posttraumatic stress disorder (PTSD). The presence of AD is associated with greater PTSD clinical severity and poorer clinical outcomes. Knowledge regarding the mechanism underlying this association is limited, though the emerging evidence has indicated that executive function deficit (EFD) is strongly correlated with AD and PTSD symptoms. While treatments developed for PTSD have existed for years, a substantial portion of individuals do not fully respond to conventional treatment. Accumulating evidence suggest that attention deficit (AD) and EFD may be a driving force for PTSD treatment resistance. However, treatment of executive impairment in PTSD is very limited. As a result, untreated co-occurring AD and EFD in PTSD poses severe negative impacts on patients' functional recovery, treatment outcomes, and quality of life (QoL). Given that up to 50% of patients do not respond well to the first-line pharmacological PTSD treatments, it is imperative to seek novel treatment strategies to improve EF that may improve both standard treatment response and QoL, social function. The proposed study directly addresses this knowledge gap by testing the efficacy of atomoxetine (ATX) in improving EF and attention among Veterans with PTSD, which will further improve Veterans' QoL and social function. ATX represents a promising novel candidate pharmacotherapy for individuals with PTSD. ATX is a non-stimulant selective norepinephrine reuptake inhibitor (SNRI), approved by the FDA for the treatment of ADHD. Studies suggest that ATX, unlike stimulants, lacks addictive properties and shows efficacy in the treatment of comorbid depression and anxiety, which is ideal in the treatment of PTSD. Data from the investigators' preliminary study provides encouraging support for the therapeutic potential of ATX in improving EF in Veterans with comorbid PTSD/ADHD. The investigators' recent research uncovered a higher rate of ADHD among Veterans with PTSD, and the comorbid AD symptoms were correlated with PTSD severity and poorer treatment outcomes. Treatment with ATX showed significant symptoms reduction in ADHD and improvement in inhibitory function in Veterans with ADHD/PTSD. In the proposed study, the investigators will focus on ATX in improvement of EF and attention, and further psycho-social life function and QoL. The investigators will (1) employ a randomized, double-blind design that will consist of 12 weeks of treatment with ATX or placebo medication; (2) use standardized, repeated dependent measures to rigorously assess AD and EFD symptomatology; (3) measure impairment in associated mental and behavioral health problems (e.g., attention deficit, depression, anxiety, suicidality, QoL, family/social functioning); and (4) use response inhibition task GoNogo, working memory and attention tests Digit Span and Trail Making to investigate the underlying pathophysiology of PTSD and prognostic indicators of treatment outcome. To achieve these goals, the investigators have assembled a multidisciplinary team with expertise in PTSD, ADHD clinical trials, and human laboratory paradigms who have successfully collaborated in the past and are uniquely qualified to implement this type of investigation. The proposed project is directly responsive to the mission of the VA-RRD "to maximize Veterans' functional independence, quality of life and participation in their lives and community." Successful completion of this study will provide a platform for a large multi-center trial to further confirm the important role of EF in PTSD treatment outcomes. The findings from this study will provide critically needed evidence to help inform clinical practice guidelines on the treatment of PTSD. The outcome of the proposed research will be significant, because it provides a knowledge base to allow for development of new PTSD intervention strategies. More importantly, this clinical trial may immediately benefit Veterans by enhancing their cognitive function, reducing AD related disability, and further improving quality of life for Veterans who suffer from PTSD.

Start Date01 Jun 2025

Sponsor / Collaborator

VA Office of Research and Development

[+1]

NCT06899178

/ Not yet recruitingPhase 2IIT

A Phase 2, Double Blind, Randomized, Placebo-controlled Crossover Trial to Evaluate the Efficacy and Safety of Atomoxetine in Adults with Melanocortin Obesity Syndrome

This is a phase 2 randomized placebo-controlled crossover trial to determine the safety and efficacy of atomoxetine for treating obesity caused by loss-of-function variants in the melanocortin-4 receptor (MC4R), the most common cause of genetic obesity disorders. Atomoxetine was selected for this pilot trial because it has been shown to increase brain-derived neurotrophic factor (BDNF) within the central nervous system and in peripheral circulation. Targeting BDNF is a specific strategy for treating MC4R abnormalities because BDNF functions as a downstream mediator of MC4R signaling.

Start Date01 Apr 2025

Sponsor / Collaborator

Icahn School of Medicine at Mount Sinai

[+1]

KCT0010317

/ Not yet recruitingNot ApplicableIIT

An exploratory clinical trial to evaluate the efficacy and safety of combined administration of atomoxetine and oxybutynin in patients with obstructive sleep apnea

Start Date01 Apr 2025

Sponsor / Collaborator

Chonnam National University Hospital

100 Clinical Results associated with Atomoxetine Hydrochloride

100 Translational Medicine associated with Atomoxetine Hydrochloride

100 Patents (Medical) associated with Atomoxetine Hydrochloride

2,942

Literatures (Medical) associated with Atomoxetine Hydrochloride

01 Jul 2025·INTERNATIONAL JOURNAL OF LAW AND PSYCHIATRY

ADHD in adults and criminal behavior: The role of psychiatric comorbidities and clinical and sociodemographic factors in a clinical sample

Article

Author: Gubbini, Silvia ; Del Casale, Antonio ; Ferracuti, Stefano ; De Rossi, Pietro ; Adriani, Barbara ; Nicolò, Giuseppe ; Parmigiani, Giovanna ; Pallottino, Simone ; Modesti, Martina Nicole ; Guariglia, Cecilia ; Manzi, Agostino

INTRODUCTION:

ADHD is a neurodevelopmental disorder associated with functional, behavioral, and relational difficulties. Its onset is in childhood, before the age of 12, and it often persists into adulthood. This study investigates the link between ADHD in adulthood, psychiatric comorbidities, and the risk of criminal behavior, analyzing the impact of clinical and sociodemographic variables.

METHODS:

This cross-sectional study included a sample of 308 patients diagnosed with ADHD, treated at the ADHD Outpatient Clinic of SS Gonfalone Hospital in Monterotondo between 2019 and 2024. Diagnoses and comorbidities were assessed through structured interviews and standardized diagnostic tools (ASRS, DIVA-5). Information on legal status and types of crimes was collected through individual interviews. Statistical analysis was performed using t-tests, chi-square tests, and stepwise logistic regression models.

RESULTS:

In the sample, 8.1 % of patients with ADHD had committed crimes, with a male prevalence (92 %). Significant predictors of criminal behavior included male gender (OR = 1.899, p = 0.004) and alcohol use disorder (OR = 4.59, p = 0.002). Additionally, oppositional defiant disorder, ADHD diagnosis before the age of 18, and unemployment showed a potential association with risky criminal behavior. Lifetime prescription of antipsychotics (61.4 %) and antiepileptics (48.7 %) was more frequent among participants who committed crimes, while no significant differences were found in the use of atomoxetine and methylphenidate.

CONCLUSIONS:

Adult ADHD, particularly in males, with combined presentation and in the presence of comorbidities such as oppositional defiant disorder and alcohol use disorder, is associated with an increased risk of criminal behavior. The findings highlight the need for personalized and multimodal interventions to mitigate these risks. Future studies should adopt longitudinal designs to explore causal dynamics and evaluate the effectiveness of therapeutic strategies in forensic contexts.

01 May 2025·ENVIRONMENTAL RESEARCH

Occurrence and risk assessment of different cyanotoxins and their relationship with environmental factors in six typical eutrophic lakes of China

Article

Author: Chen, Wei ; Yao, Yujia ; Yang, Huiting ; Gu, Xiaohong ; Zeng, Qingfei ; Chen, Huihui ; Xiang, Tao ; Mao, Zhigang

Cyanobacterial blooms can generate various toxic metabolites in freshwater, and pose serious threats to drinking water safety and human health. Although microcystins (MCs) have been detected in many freshwater ecosystems in China, little is known about the other cyanotoxins. An investigation of six eutrophic lakes (i.e. Hulun Lake, Wuliangsuhai Lake, Chaohu Lake, Taihu Lake, Xingyun Lake, and Dianchi Lake) in different geographical locations of China was performed during the summer of 2022 to determine the occurrence of various cyanotoxins (i.e. anatoxin-a (ATX), cylindrospermopsin (CYN), and MCs) in water column and their possible risks, and to evaluate the related environmental factors. MCs levels in sediment of these lakes were also investigated. MCs were the primary cyanotoxins in the water column of investigated lakes. The mean MCs contents in water column of Hulun Lake, Wuliangsuhai Lake, Chaohu Lake, Taihu Lake, Xingyun Lake, and Dianchi Lake were 3.61, 0.13, 3.60, 2.18, 0.57, and 2.56 μg/L, respectively. The total MCs levels in water column exceeded 1 μg/L in some areas of these lakes except Wuliangsuhai Lake. Replete nitrogen and/or phosphorus levels seemed to be related to MCs production. ATX can be detected in these lakes except Xingyun Lake at ng/L levels. CYN can be detected in all lakes at ng/L levels. However, the levels of ATX and CYN appear to be not significantly associated with environmental factors. MCs and CYN can pose a high or moderate risk for humans and aquatic organisms in some areas of these lakes, while ATX can pose a low or no risk for humans and aquatic organisms in most areas of these lakes. MCs can also be detected in sediment of all lakes at ng/g levels. This research emphasizes the necessity for long-term monitoring of different cyanotoxins in eutrophic lakes, and the implementation of nutrient control and management strategies.

01 May 2025·The Lancet Psychiatry

Comparative cardiovascular safety of medications for attention-deficit hyperactivity disorder in children, adolescents, and adults: a systematic review and network meta-analysis

Review

Author: Farhat, Luis C ; Cipriani, Andrea ; Garcia-Argibay, Miguel ; Fava, Cristiano ; Tomlison, Anneka ; Ostinelli, Edoardo G ; Del Giovane, Cinzia ; Revet, Alexis ; Cortese, Samuele ; Larsson, Henrik ; Montastruc, François ; Chang, Zheng ; Parlatini, Valeria ; Lannes, Alice

BACKGROUND:

Concerns about the cardiovascular safety of medications used for the treatment of attention-deficit hyperactivity disorder (ADHD) remain. We aimed to compare the effects of pharmacological treatments for ADHD on haemodynamic values and electrocardiogram (ECG) parameters in children, adolescents, and adults.

METHODS:

For this systematic review and network meta-analysis, we searched 12 electronic databases, including Cochrane CENTRAL, Embase, PubMed, and the WHO International Clinical Trials Registry Platform, from database inception to Jan 18, 2024, for published and unpublished randomised controlled trials comparing amphetamines, atomoxetine, bupropion, clonidine, guanfacine, lisdexamfetamine, methylphenidate, modafinil, or viloxazine against each other or placebo. Primary outcomes were change in systolic blood pressure (SBP) and diastolic blood pressure (DBP), measured in mm Hg, and pulse, measured in beats per minute, at timepoints closest to 12 weeks, 26 weeks, and 52 weeks. Summary data were extracted and pooled in random-effects network meta-analyses. Certainty of evidence was assessed with the Confidence in Network Meta-Analysis (CINeMA) framework. This study was registered with PROSPERO, CRD42021295352. Before study initiation, we contacted representatives of a UK-based charity of people with lived experience of ADHD-the ADHD Foundation-regarding the relevance of the topic and the appropriateness of the outcomes chosen.

FINDINGS:

102 randomised controlled trials with short-term follow-up (median 7 weeks [IQR 5-9]) were included, encompassing 13 315 children and adolescents (aged ≥5 years and <18 years; mean age 11 years [SD 3]; of available data, 9635 [73%] were male and 3646 [27%] were female; of available data, 289 [2%] were Asian, 1719 [15%] were Black, and 8303 [71%] were White) and 9387 adults (≥18 years, mean age 35 years [11]; of available data, 5064 [57%] were male and 3809 [43%] were female; of available data, 488 [6%] were Asian, 457 [6%] were Black, and 6372 [79%] were White). Amphetamines, atomoxetine, lisdexamfetamine, methylphenidate, and viloxazine led to increments in haemodynamic values in children and adolescents, adults, or both. In children and adolescents, mean increase against placebo ranged from 1·07 (95% CI 0·36-1·79; moderate CINeMA confidence) with atomoxetine to 1·81 (1·05-2·57; moderate) with methylphenidate for SBP; from 1·93 (0·74-3·11; high) with amphetamines to 2·42 (1·69-3·15; low) with methylphenidate for DBP; and from 2·79 (1·05-4·53; moderate) with viloxazine to 5·58 (4·67-6·49; high) with atomoxetine for pulse. In adults, mean increase against placebo ranged from 1·66 (95% CI 0·38-2·93; very low) with methylphenidate to 2·3 (0·66-3·94; very low) with amphetamines for SBP; from 1·60 (0·29-2·91; very low) with methylphenidate to 3·07 (0·69-5·45; very low) with lisdexamfetamine for DBP; and from 4·37 (3·16-5·59; very low) with methylphenidate to 5·8 (2·3-9·3; very low) with viloxazine for pulse. Amphetamines, lisdexamfetamine, or methylphenidate were not associated with larger increments in haemodynamic values compared with atomoxetine or viloxazine in either children and adolescents or adults. Guanfacine was associated with decrements in haemodynamic values in children and adolescents (mean decrease against placebo of -2·83 [95% CI -3·8 to -1·85; low CINeMA confidence] in SBP, -2·08 [-3 to -1·17; low] in DBP, and -4·06 [-5·45 -2·68; moderate] in pulse) and adults (mean decrease against placebo of -10·1 [-13·76 to -6·44; very low] in SBP, -7·73 [-11·88 to -3·58; very low] in DBP, and -6·83 [-10·85 to -2·81; very low] in pulse). Only four RCTs informed on effects in the medium term and none on the long term.

INTERPRETATION:

Practitioners should monitor blood pressure and pulse in patients with ADHD treated with any pharmacological intervention, and not stimulants only. Given the short duration of available randomised controlled trials, new research providing insights on the causal effects of ADHD medications on cardiovascular parameters in the longer term should be funded.

FUNDING:

National Institute for Health and Care Research.

News (Medical) associated with Atomoxetine Hydrochloride

17 Mar 2025

·www.fiercepharma.com

Dr. Reddy’s, Sun Pharma and Zydus issue US recalls, citing failed specs and labeling issues

Multiple drugmakers have had to yank their products in the U.S. this year over manufacturing and quality concerns. A trio of drugmakers have issued separate recalls in the U.S. thanks to string of production flubs, including failed impurity and dissolution specifications and incorrect labelling of infusion bags.The companies behind the product pulls are Dr. Reddy’s Laboratories, Sun Pharma and Zydus Pharmaceuticals, all three of which hail from India. The drugmakers are recalling seizure treatments, painkillers and a chemotherapy drug, respectively, according to the FDA’s online enforcement report, which the regulator uses to catalogue recalls. In the case of Dr. Reddy’s, the company unveiled a voluntary recall on March 13 for one lot of 1,000 mg/100 ml single-dose levetiracetam infusion bags that had been shipped out across the U.S. in early November. The infusion bags from the suspect batch were incorrectly labeled as 500 mg/100 ml levetiracetam in 0.82% sodium chloride injection, while the aluminum overwrap packaging correctly identifies the product as levetiracetam in 0.75% sodium chloride injection 1,000 mg/100 ml, Dr. Reddy’s explained in its recall notice.Levetiracetam is typically used to treat certain types of seizures when patients are unable to take an oral medication. Although Dr. Reddy’s says there have so far been no reported safety events related to the product pull, patients receiving higher-than-expected doses of the drug by rapid intravenous infusion are at risk of “immediate and serious side effects,” including liver injury, respiratory depression and coma, the company explained. Sun Pharma, for its part, is recalling nearly 10,000 100 mg bottles of morphine sulfate extended-release tablets after the products failed to meet FDA dissolution specifications. The painkillers are part of lot AD16615, which was set to expire in July. The morphine sulfate tablets at issue were distributed nationwide, according to the FDA’s enforcement report.Sun initiated the Class II recall on Feb. 6. The tablets were manufactured by the Indian drugmaker’s subsidiary Ohm Laboratories in New Brunswick, New Jersey.Lastly, Zydus Pharmaceuticals initiated two separate Class II recalls on Feb. 13 covering a whopping 38,871 vials of the chemotherapy injection nelarabine, which were manufactured at the company’s Ahmedabad, India, production facility.The drugmaker issued the recall due to failed impurity and degradation specifications, the FDA’s enforcement report notes.The far-reaching product pull accounts for more than 20 lots of the chemotherapy med, which were set to expire as early as last month or as late as July 2026, depending on the specific batch. Multiple drugmakers have had to yank their products in the U.S. this year, with one recent recall yielding significant interest for its scope and treatment type.Earlier this month, Glenmark Pharma revealed it was recalling some 1.48 million bottles of the generic attention-deficit/hyperactivity disorder (ADHD) drug atomoxetine after detecting unacceptable levels of a possible carcinogen in the product.Atomoxetine—previously sold by Eli Lilly under the brand name Strattera—is a selective norepinephrine reuptake inhibitor (sNRI) independent of the stimulant-based offerings that make up the bulk of ADHD treatment.

Drug Approval

11 Mar 2025

·www.prnewswire.com

Apnimed Appoints Kevin R. Lind as Non-Executive Chairman of the Board of Directors

– Larry Miller, CEO, to Continue Serving as Non-Independent Board Director – Phase 3 SynAIRgy and LunAIRo Clinical Trials on Track for Topline Results in 2Q2025 and 3Q2025, Respectively CAMBRIDGE, Mass., March 11, 2025 /PRNewswire/ -- Apnimed, Inc., a pharmaceutical company focused on discovering, developing, and commercializing first-in-class oral therapies for the neuromuscular dysfunction associated with obstructive sleep apnea (OSA) and other sleep-related breathing diseases, today announced the expansion of its Board of Directors with the appointment of Kevin R. Lind as non-executive Chairman of the Board. Mr. Lind brings decades of experience from the biotech and financial sectors. "We are thrilled to welcome Kevin to Apnimed's Board," said Larry Miller, MD, Chief Executive Officer of Apnimed. "His proven leadership in biotechnology and corporate strategy will provide invaluable insights as we approach Phase 3 clinical trial results for AD109 and prepare for its potential commercial launch as a once-nightly oral therapy for OSA. Our team has been executing to our stated milestones and, most importantly, our ongoing Phase 3 trials are on track to report top-line results in 2Q2025 and 3Q2025, respectively." "Apnimed is well-positioned for growth with both its promising late-stage asset, AD109, and its synergistic partnership with Shionogi to drive long-term value," said Mr. Lind. "I am excited to join Apnimed at this pivotal time and look forward to contributing to the company's continued clinical and future commercial successes." About Kevin Lind Kevin Lind recently served as Longboard Pharmaceuticals' President and Chief Executive Officer and as a member of its board from the company's inception in 2020 until Longboard was acquired by H. Lundbeck A/S in December 2024. Prior to co-founding Longboard Pharmaceuticals, Mr. Lind served as EVP and Chief Financial Officer during the turnaround of Arena Pharmaceuticals (acquired by Pfizer) from 2016 to 2020. As an executive leader at these organizations, he successfully raised over $1.1B in equity capital (including Longboard's IPO), secured valuable business development partnerships (including ~$1B in upfront payments), spun out two organizations, and was instrumental in activities resulting in the successful acquisitions of both companies for a cumulative value of ~$9.3B. At Longboard, Mr. Lind also led the initiation of a global Phase 3 program for a neurological drug candidate, bexicaserin, and innovative drug development strategies resulting in the conceptualization of a novel medical indication and securing of Breakthrough Therapy designation from the U.S. FDA. Prior to Longboard, Mr. Lind focused on healthcare investing at TPG Special Situations Partners from 2009 to 2016 and at TPG-Axon from 2006 to 2008. He served in various capacities as a healthcare investment banker at Lehman Brothers, Inc., a former global financial services firm, from 1998 to 2002 and 2004 to 2006. Mr. Lind received a B.S. from Stanford University in Biological Sciences and an MBA from UCLA Anderson School of Management. About AD109 AD109 is a once-nightly oral pill that could be the first pharmacological treatment to improve oxygenation during sleep by directly targeting the underlying neuromuscular dysfunction that causes the upper airway to collapse in people with obstructive sleep apnea (OSA). It is a first-in-class combination of aroxybutynin, a novel antimuscarinic, and atomoxetine, a selective norepinephrine reuptake inhibitor (NRI). Their combined pharmacological synergy targets the root neuromuscular cause of OSA. In a disease characterized by complex and invasive treatment options, AD109 may offer a simple solution to help improve oxygenation and overall health for people living with OSA. AD109 has successfully completed multiple Phase 1 and Phase 2 trials in OSA. The Phase 3 program is fully enrolled with topline results expected in mid-2025. About Obstructive Sleep Apnea Obstructive sleep apnea (OSA) is a serious, chronic sleep-related breathing disease in which the upper airway repeatedly collapses during sleep, leading to intermittent oxygen deprivation. It is caused by two overlapping mechanisms: neuromuscular dysfunction during sleep and predisposing anatomic abnormalities. It has been demonstrated that OSA affects people of all body types, ages and genders —there is no single "face" of the disease. An estimated 80 million people in the United States and 1 billion people worldwide suffer from OSA. An individual with OSA can experience hundreds of sleep apnea events in a single night, each one reducing the blood oxygen levels and negatively impacting cellular functions vital to normal health and function. Failure to effectively treat OSA increases the risk of serious long-term health consequences, such as high blood pressure, cardiovascular disease and type 2 diabetes, along with impacts on quality of life, including daytime fatigue and impaired judgement. Yet, the majority of those diagnosed with OSA refuse, abandon, or underutilize treatment. Currently, no available pharmacological treatments directly address the underlying neuromuscular dysfunction that is present in all people with OSA. About Apnimed Apnimed is a privately held clinical-stage pharmaceutical company dedicated to transforming the treatment landscape for sleep-related breathing diseases. Apnimed envisions a new era where novel oral therapies simplify intervention, expand the reach of diagnosis and treatment, and help more people get the oxygen and restorative sleep needed to thrive. Based in Cambridge, Mass., Apnimed is advancing a robust pipeline of oral pharmaceutical product candidates designed to improve oxygenation in individuals living with OSA and other sleep-related breathing disorders. This includes AD109, which is currently in Phase 3 clinical trials for the treatment of mild, moderate and severe OSA, as well as several therapies being developed as part of our joint venture with Shionogi & Co., Ltd, through Shionogi Apnimed Sleep Science (SASS). Learn more at apnimed.com or follow us on X and LinkedIn. Media Contact: [email protected] Investor Contact: Ramzi Benamar [email protected] SOURCE Apnimed, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Executive ChangePhase 3IPO

04 Mar 2025

·www.fiercepharma.com

Glenmark issues another recall, this time for nearly 1.5M bottles of generic ADHD drug

Glenmark Pharma is recalling nearly 1.5 million bottles of the attention-deficit/hyperactivity disorder drug atomoxetin. Glenmark Pharma, an India-based drug manufacturer that has been the focal point of a spate of recalls in recent years, has issued another. This time, the product pull covers about 1.48 million bottles of the generic attention-deficit/hyperactivity disorder (ADHD) drug atomoxetine.Eli Lilly previously sold the branded version of the drug, Strattera, but discontinued all strengths in 2023 after the arrival of generics.Unlike stimulant-based drugs that make up the bulk of ADHD treatment, including those like Vyvanse and Adderall, atomoxetine is a selective norepinephrine reuptake inhibitor (sNRI).The recall was triggered by the presence of unacceptable levels of N-nitroso atomoxetine, a possible carcinogen, in multiple Glenmark atomoxetine batches, according to the FDA. The voluntary pull, which began Jan. 29, covers bottles of the drug in strengths ranging from 10 mg to 100 mg, the FDA said on its Enforcement Report webpage. The ADHD drugs were manufactured in Glenmark’s facility in Goa, India, and were distributed nationwide. Glenmark has weathered a string of recalls in recent years due to both manufacturing and labelling issues.In June 2024, the company recalled 114 batches of 750 mg potassium chloride extended-release capsules—or roughly 47 million capsules—over concerns that they failed to dissolve properly.In December, the company recalled 90,528 bottles of the high blood pressure drug diltiazem hydrochloride in tablet and extended-release forms due to unacceptable levels of another N-nitroso compound, N-nitroso-Desmethyl-Diltiazem.In separate actions in 2023, Glemark recalled 1,200 bottles of trandolapril and verapamil hydrochloride extended-release tablets used to treat high blood pressure; 37,200 bottles of Indomethacin, which is a non-steroidal anti-inflammatory used to treat pain and arthritis symptoms; and five lots (no bottle count provided) of Naproxen that is used to reduce fever or relieve mild pain.The previous year it recalled 98,307 packs of mometasone furoate topical solution, a corticosteroid lotion that treats skin conditions such as eczema, psoriasis, allergies and rash.

Clinical Result

100 Deals associated with Atomoxetine Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D02574	Atomoxetine Hydrochloride	N06BA09	DB00289

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Attention Deficit Disorder With Hyperactivity	United States	Eli Lilly & Co.	26 Nov 2002

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Cognitive Dysfunction	Phase 3	United States	Eli Lilly & Co.	01 Nov 2005
Generalized anxiety disorder	Phase 3	-	Eli Lilly & Co.	01 Nov 2005
Neoplasms	Phase 3	United States	Eli Lilly & Co.	01 Nov 2005
Phobia, Social	Phase 3	-	Eli Lilly & Co.	01 Nov 2005
Attention Deficit and Disruptive Behavior Disorders	Phase 3	Australia	Eli Lilly & Co.	01 Dec 2003
Attention Deficit and Disruptive Behavior Disorders	Phase 3	Belgium	Eli Lilly & Co.	01 Dec 2003
Attention Deficit and Disruptive Behavior Disorders	Phase 3	Denmark	Eli Lilly & Co.	01 Dec 2003
Attention Deficit and Disruptive Behavior Disorders	Phase 3	Finland	Eli Lilly & Co.	01 Dec 2003
Attention Deficit and Disruptive Behavior Disorders	Phase 3	Germany	Eli Lilly & Co.	01 Dec 2003
Attention Deficit and Disruptive Behavior Disorders	Phase 3	Netherlands	Eli Lilly & Co.	01 Dec 2003

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04905979 (Pubmed \| Sleep Breath)	Phase 2	Sleep Apnea, Obstructive \| Hypertension	-	Atomoxetine 80 mg	duobzedgbg(pudvnyshoq) = lxjwdpzysh elzvjargue (nytwcmyvht, 18.8 - 28.5) View more	Positive	01 Dec 2024
				Atomoxetine 80 mg + Spironolactone 80/50 mg	duobzedgbg(pudvnyshoq) = fkldungcdw elzvjargue (nytwcmyvht, 5.7 - 14.1)
NCT04445688 (Pubmed \| Sleep Breath)	Phase 2	Sleep Apnea, Obstructive	62	AD036 (atomoxetine 80 mg and oxybutynin 5 mg)	ejnrlnxiuo(qxjleiiixn) = nxtonijhkp nriyyxswxe (mwfgyfiwva, 2.8 - 13.6)	Positive	13 May 2022
				Atomoxetine 80 mg alone	ejnrlnxiuo(qxjleiiixn) = xgdifqcyle nriyyxswxe (mwfgyfiwva, 1.4 - 11.6)
WSC2022	Phase 2	-	30	Atomoxetine 75 mg + Aroxybutynin 2.5 mg	uoprxuchyz(lznfqgpbdo) = flykzzjjza lhzrrwuvac (kdnvvpwmkx ) View more	Positive	11 Mar 2022
				Atomoxetine 37.5 mg + Aroxybutynin 2.5 mg	uoprxuchyz(lznfqgpbdo) = azvcfpqeij lhzrrwuvac (kdnvvpwmkx ) View more
NCT00628394 (CTgov)	Phase 4	Schizophrenia	119	Atomoxetine (Atomox/CR)	wbrckinqov(oknmmipqke) = qhzsogslhg sbcnpeuqrr (vqhcsldipw, 1.71) View more	-	25 Sep 2020
				Atomoxetine (Atomox/Control)	wbrckinqov(oknmmipqke) = ormnmizicm sbcnpeuqrr (vqhcsldipw, 1.77) View more
NCT01340885 (CTgov)	Phase 4	Cognitive Dysfunction \| Parkinson Disease	9	Strattera (Atomoxetine)	abzdntspyx(zduixoimjp) = xcwpagjxju nvqipkgvho (tghwmgwkfc, grsasuxtts - mgblkpzhmf) View more	-	07 Jul 2020
				Exelon (Rivastigimine)	abzdntspyx(zduixoimjp) = omlcwkktfg nvqipkgvho (tghwmgwkfc, idlgwupnwc - sezprolxim) View more
NCT02500732 (POST6, CTgov)	Phase 2	Syncope, Vasovagal	57	Placebo (Placebo)	wwcgiqhubr = nhjlmbjjox slxkjxijeo (dtqscswrcu, danwgzdtaf - suckvpclrx) View more	-	21 Apr 2020
				Atomoxetine (Atomoxetine)	wwcgiqhubr = eiomfvcqmq slxkjxijeo (dtqscswrcu, ialglotvou - hgihakkrac) View more
NCT00918567 (CTgov)	Phase 4	Attention Deficit Disorder With Hyperactivity	56	Behavior Modification Therapy+atomoxetine (Combined Therapy)	barnmbqqee(tnmhdbmxdh) = jzjmiugvtj pbqlstozwt (jfqnaxatbi, 1.37) View more	-	07 Apr 2020
				atomoxetine (Drug Therapy)	barnmbqqee(tnmhdbmxdh) = obnufrqtvr pbqlstozwt (jfqnaxatbi, 1.36) View more
NCT03091400 (CTgov)	Phase 2	Amnesia, Anterograde \| Multiple Sclerosis	11	Atomoxetine (Atomoxetine)	goqxdjvktz(vcpcscsvqz) = insxbofnop qosxpeqhsx (ynwkubqiiw, 0.60) View more	-	13 Mar 2020
				Placebo (Placebo)	goqxdjvktz(vcpcscsvqz) = mxdhxkolxg qosxpeqhsx (ynwkubqiiw, 0.46) View more
NCT01522404 (ATX-001, CTgov)	Phase 2	Mild cognitive disorder	39	Placebo+Atomoxetine (Atomoxetine / Inactive Compound)	tqwmokgdst(ncxiwduewe) = eytnwecwhv magyaqyxcs (aadxwbftih, 8.6) View more	-	05 Dec 2018
				Placebo+Atomoxetine (Inactive Compound / Atomoxetine)	tqwmokgdst(ncxiwduewe) = ebvwoeexln magyaqyxcs (aadxwbftih, 7.5) View more
NCT01738191 (ATM-Cog, CTgov)	Phase 2	Cognitive Dysfunction \| Parkinson Disease	30	Atomoxetine (Atomoxetine)	rtnkbpppio(rtimnoidvr) = fkguzjolng wynvpcfxnp (bmdmqljzin, bwgxocnjcp - uduzvasmwl) View more	-	23 Aug 2018
				Placebo (Placebo)	rtnkbpppio(rtimnoidvr) = ouddgazzuq wynvpcfxnp (bmdmqljzin, nztyugxuuk - xdxottoqws) View more

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