The Clinical Efficacy of Intravesical Botox Injections When Combined With HoLEP Surgery in Patients With Benign Prostatic Hyperplasia and Overactive Bladder

Benign prostatic hyperplasia (BPH) is the most common benign neoplasm in men. Almost 90% of men in their 70s report lower urinary tract symptoms related to BPH. These symptoms carry a significant negative impact on the patients' quality of life.
Despite the wide availability of surgical offerings to relieve bladder outlet obstruction such as transurethral resection of the prostate (TURP), Holmium Laser Enucleation of the Prostate (HoLEP), and prostatectomy, many patients still suffer from persistent LUTS after undergoing these. A study describing postoperative outcomes following HoLEP revealed that patients with severe lower urinary tract symptoms, storage-positive sub-score, and high maximum urinary flow rate before the surgery were affected by a rebound of mainly storage symptoms 6-8 weeks after HoLEP and prolonged recovery from LUTS with 7.4% of them presenting for persistent urge complaints.
Optimizing the management approach for these patients has been limited by lack of high level evidence-based recommendations and expert consensus. Intravesical botox injections are well-established therapeutic options for several urinary disorders. The current practice offers intravesical botox injections to patients who suffer from persistent urinary symptoms few months after their BPH procedure. This study aims to evaluate if giving botox injections at the time of the HoLEP surgery would yield a better outcome than performing the two procedures separately at different times (few months apart).
The concomitant use of botox injection during bladder de-obstructing procedures has been previously studied in TURP and have showed a significant reduction of incontinence episodes and OAB symptoms in the group that were treated with botox injections after 36 weeks post TURP. This data may suggest promising potential of this intervention in managing persistent OAB symptoms in patients with BOO. However, the efficacy of combining HoLEP and bladder Botox injections has not been systematically studied and evaluated.
The aim of this study is to evaluate the effect of intravesical Botox injections on lower urinary tract symptoms (LUTS) when administered during HoLEP surgery in patients with bladder outlet obstruction (BOO) and overactive bladder symptoms (OAB). The investigators are interested in comparing the postoperative outcome in terms of recovery and symptom relief in patients who performed HoLEP surgery with bladder Botox injections versus those who performed HoLEP surgery only at 2 weeks,1 month, 3 months, and 6 months postoperatively.
The investigators hypothesize that administering bladder botox injections during HoLEP surgery is a combination treatment that will result in faster and more potent symptom relief compared to patients who received only a HoLEP surgery for their obstructive and irritative symptoms.

Start Date01 Jun 2026

Sponsor / Collaborator

University Hospitals Cleveland Medical Center

NCT07025642

/ RecruitingNot ApplicableIIT

Outcome of Different Treatments of Overactive Bladder in Taiwan

Overactive bladder (OAB) syndrome is a prevalent condition that significantly impairs patients' quality of life. Standard therapeutic strategies include oral antimuscarinics (e.g., solifenacin), beta-3 adrenergic agonists (e.g., mirabegron), and intradetrusor injection of botulinum neurotoxin type A (BoNTA). Despite their clinical utility, these treatments share a common mechanism of action: suppression of detrusor muscle contractility. However, it remains unclear whether such suppression translates to a reduction in the overall mechanical work output of the bladder during micturition.
To address this question, our research proposes to assess how mirabegron, solifenacin, and BoNTA influence bladder function from a thermodynamic perspective. We will apply pressure-volume analysis (PVA), a methodology traditionally used in cardiac physiology, to quantify the mechanical work performed by the bladder per voiding cycle. This approach enables a direct measurement of the energy expenditure required for bladder emptying, offering insights beyond standard urodynamic parameters.
Furthermore, emerging data suggest BoNTA may exert additional effects beyond parasympathetic inhibition. Specifically, recent studies have demonstrated that BoNTA also inhibits norepinephrine release from sympathetic hypogastric nerve terminals. Since modulation of sympathetic activity-particularly via the hypogastric nerve-has been implicated in regulating bladder compliance and storage function, we hypothesize that BoNTA may influence bladder compliance through this secondary mechanism. To explore this, we will employ volume-pressure analysis (also abbreviated as PVA), which graphically represents the dynamic relationship between bladder volume and pressure throughout voiding cycles, thus capturing real-time changes in compliance.
Comparative studies of mirabegron, solifenacin, and BoNTA will allow us to differentiate their respective impacts on bladder work and compliance. Mirabegron, which selectively activates beta-3 adrenergic receptors, has minimal influence on overall sympathetic tone. In contrast, solifenacin not only antagonizes muscarinic receptors but may also indirectly potentiate sympathetic tone by reducing parasympathetic influence. BoNTA, with its dual action on both autonomic pathways, provides a unique model to dissect these neural mechanisms.
To extend our findings from clinical observations to preclinical validation, we aim to develop and utilize a spinal cord injury (SCI) rat model that recapitulates the bladder dysfunction observed in neurogenic detrusor overactivity (NDO)-a condition for which mirabegron, solifenacin, and BoNTA are also commonly prescribed. By applying both thermodynamic and compliance-focused PVA techniques in this animal model, we seek to construct a foundational database characterizing how these drugs modulate bladder function in a controlled, reproducible setting.
In summary, this project integrates a novel application of pressure- and volume-based analyses to quantify the mechanical and compliance-related effects of established OAB therapies in both human patients and a translational animal model. The findings will provide new mechanistic insights into how these treatments alter bladder physiology, potentially guiding future therapeutic strategies and optimizing drug selection for individualized patient care.

Start Date01 Jul 2025

Sponsor / Collaborator

Mackay Medical College

NCT06928246

/ Not yet recruitingPhase 1IIT

Pilot Study on Cellular and Molecular Impact of Neuroimmune Interactions in Atopic Dermatitis

The purpose of this study is to understand cellular and molecular interactions in the skin of participants with mild-to-moderate AD, and how botulinum toxin alters these interactions.

Start Date01 Jul 2025

Sponsor / Collaborator

University of Pittsburgh

[+1]

100 Clinical Results associated with Onabotulinumtoxin A

100 Translational Medicine associated with Onabotulinumtoxin A

100 Patents (Medical) associated with Onabotulinumtoxin A

5,293

Literatures (Medical) associated with Onabotulinumtoxin A

31 Dec 2025·ANNALS OF MEDICINE

Systematic review of pharmacotherapy for atypical facial pain: evaluation of pain reduction, depression, anxiety and quality of life

Review

Author: Alshammari, Sattam S. ; Alassaf, Hind M. ; Alqarni, Ali A. ; Abed, Hassan H. ; Shaikh, Sameer ; Alkurdi, Khlood A. ; Alshammari, Abdullah F. ; Alshammary, Freah L. ; Madfa, Ahmed A.

BACKGROUND/PURPOSE:

Atypical facial pain (AFP) is a chronic condition characterized by persistent facial pain without clear clinical signs, making diagnosis and treatment difficult. Common pharmacological treatments include antidepressants, anticonvulsants and neuromodulators, but their effectiveness remains uncertain, necessitating a systematic review to guide clinical practice.

MATERIALS AND METHODS:

Following PRISMA 2020 guidelines, randomized controlled trials (RCTs) evaluating pharmacological treatments for AFP in adults were included. A comprehensive search of five databases without date restrictions was performed. Data on pain reduction, quality of life, and adverse events were extracted. The Cochrane Risk of Bias (RoB 2.0) tool assessed bias, and evidence quality was evaluated using the Critical Appraisal Skills Programme tool.

RESULTS:

Out of 196 studies identified, 10 RCTs met the inclusion criteria. Pharmacological responses varied significantly across studies. Antidepressants such as dothiepin and clomipramine demonstrated significant pain reduction, whereas venlafaxine showed limited efficacy. However, onabotulinum toxin A and sumatriptan exhibited inconsistent or minimal effects on AFP pain intensity. Adverse events were reported across multiple treatments, ranging from mild side effects such as dry mouth and nausea to severe reactions like diplopia and facial asymmetry, which impacted adherence. Despite some positive outcomes, the heterogeneity in study methodologies, outcome measures, and follow-up durations limited direct comparisons between interventions.

CONCLUSION:

This systematic review highlights the mixed efficacy of pharmacological treatments for AFP, with certain medications demonstrating superior pain relief in specific patient subgroups. Given the variability in response and adverse events, a multimodal approach combining pharmacological and non-pharmacological therapies may offer the most effective management strategy. Future research should focus on standardized treatment protocols, long-term efficacy, and personalized treatment plans to optimize patient care.

01 Dec 2025·Techniques in Coloproctology

Management of chronic anal fissures: should fissurectomy be performed with botulinum toxin injection?

Article

Author: Albayati, S ; Ellis-Clark, J ; Quinn, R

Abstract:

Background:

Despite the superior success rate of lateral internal sphincterotomy for managing chronic anal fissure (CAF), there is a trend towards sphincter-preserving treatment due to the increased risk of incontinence. Botulinum toxin (BT) and fissurectomy are two sphincter-preserving options for CAF. We aim to assess if combining fissurectomy with botox treatment is superior to botulinum toxin alone in the management of CAF.

Methods:

This retrospective cohort study was conducted across two Sydney hospitals over 7 years. All patients with a CAF managed with either BT and fissurectomy (group 1) or BT only (group 2) were included. Primary outcome was healing rate defined as resolution or significant improvement of perianal symptoms at initial follow-up. Secondary outcomes were persistence, recurrence, re-intervention and faecal incontinence rate. Follow-up questionnaire was conducted to compare long-term outcomes between the two groups.

Results:

Fifty-seven patients met the inclusion criteria (group 1, 37; group 2, 20). Mean BT dose and injection location between the groups were similar (p = 0.259 and p = 0.427). There was a 65% response rate to the follow-up questionnaire. Median follow-up was 34.3 months (range 0.4–93). There was no difference in healing (56.7% vs. 50%, p = 0.561), recurrence (37.8% vs. 30%, p = 0.383) or re-intervention rate (13.5% vs. 20%, p = 0.888). Long-term incontinence rate was significantly higher in patients group 2 (0% vs. 10%, p = 0.010), with two patients reporting persistent flatus incontinence. Median overall satisfaction score was 3/4 (range 1–4), in both groups (p = 0.469).

Conclusion:

Botulinum toxin with or without fissurectomy is a safe sphincter-sparing treatment option for CAF. However, the addition of fissurectomy to BT does not improve healing rates and we therefore recommend BT injection alone as a second-line treatment of CAF in patients who fail topical treatment.

01 Dec 2025·Current Pain and Headache Reports

Prognostic Value of Minnesota Multiphasic Personality Inventory-2 (MMPI-2) Profiles in Predicting Outcomes of Occipital Nerve Stimulation for Refractory Chronic Migraine: A Retrospective Bias-Corrected Multivariable Analysis

Review

Author: Naccarato, Alessia ; Varrassi, Giustino ; Viswanath, Omar ; Arcioni, Roberto ; Sarmi, Samah Said Al ; Leoni, Matteo Luigi Giuseppe ; Mercieri, Marco ; Cascella, Marco

Abstract:

Background:

Refractory chronic migraine (rCM) is characterized by debilitating headaches that do not respond adequately to conventional medical treatments, leaving patients severely disabled. In these rare cases, central cervical spinal cord stimulation or occipital nerve stimulation (ONS) may offer a potential therapeutic option. However, these techniques are not without risks, lack clear scientific evidence, and impose a significant economic burden. Therefore, it is crucial to identify parameters that can assist physicians in selecting appropriate candidates for implantation. This study aimed to investigate the role of psychological profiles in predicting outcomes for ONS in rCM patients.

Methods:

We conducted a retrospective analysis on rCM patients treated with ONS at a second-level neuromodulation university facility. These patients were refractory to conventional medical treatments, including onabotulinumtoxin-A injections (monoclonal antibodies targeting CGRP were not yet available). The NRS for migraine intensity, the number of monthly migraine attacks, and drug consumption were assessed at 6-month and 12-month follow-ups post-implant. Psychological profiles were evaluated prior to OCN using the Minnesota Multiphasic Personality Inventory-2 (MMPI-2). A multivariable logistic regression model was developed to predict ONS outcomes, incorporating MMPI-2 as a covariate. The model’s accuracy and performance were assessed through non-parametric bootstrap, calibration, and discrimination analyses.

Results:

Twenty-three rCM patients were analysed. ONS was able to significantly reduce the pain intensity, the number of headache attacks per month, and drug consumption compared to pre-treatment levels at both 6- and 12-month follow-ups. The final multivariable logistic model at 12 months showed that the MMPI-2 Depression score was independently and negatively associated with favourable outcomes following ONS (optimism-adjusted OR 0.52, 95% CI 0.21–0.77, p = 0.03). The ROC curve indicated high model sensitivity (AUC: 0.96, 95% CI: 0.88–0.98), and the calibration plot revealed a good fit, with some improvement needed in mid-range predicted probabilities.

Conclusion:

ONS significantly reduced pain intensity, headache frequency, and drug use at the 12-month follow-up compared to pre-treatment levels. The MMPI-2 Depression score was an independent predictor of ONS failure, highlighting the importance of comprehensive psychological assessments in patient selection for ONS.

347

News (Medical) associated with Onabotulinumtoxin A

11 Jul 2025

·www.prnewswire.com

The Inner Circle acknowledges, Carolyn W. Quist, DO, FACOOG as a Pinnacle Lifetime Member

FORT WORTH, Texas, July 11, 2025 /PRNewswire/ -- Prominently featured in The Inner Circle, Carolyn W. Quist, DO, FACOOG is acknowledged as a Pinnacle Lifetime Member for her contributions as a Leading Advocate for Women's Health and Well-being. Dr. Carolyn W. Quist, a renowned osteopathic gynecologist, credits much of her success to the guidance and support of her mentors, Dr. John Chapman, DO, and Dr. Steve Buchanan, DO. She also acknowledges Dr. Ronald Ayres and Dr. Ron Librizzi as instrumental in her professional development, providing invaluable support and influence throughout her career. Continue Reading Carolyn W. Quist, DO, FACOOG With a focus on hormone replacement therapy and aesthetic procedures, Dr. Quist's expertise and commitment to excellence have made her a trusted healthcare provider in her community. She earned her Bachelor of Science in pre-medical studies from the University of Texas at Arlington before completing her Doctor of Osteopathic Medicine Degree from the University of North Texas Health Science Center–Texas College of Osteopathic Medicine. She has also been involved with the American Osteopathic Association for many years and is currently chair of the Bureau of Osteopathic Specialists. As the medical director for Revitalize Wellness Center, PA, Dr. Quist oversees a range of aesthetic procedures, including vaginal therapy, Botox treatments, peptides, and hair loss treatments. She is dedicated to helping women look and feel their best, offering treatments that enhance both their physical appearance and overall well-being. Her staff now includes a certified nurse practitioner specializing in family medicine, whose addition has been invaluable in providing comprehensive services to her patients. Throughout her career, Dr. Quist has been dedicated to promoting women's health and well-being. She provides routine gynecology care, hormone therapy, and aesthetic treatments to address a variety of women's health issues, including menopause management and sexual dysfunction treatments. Outside of her medical practice, Dr. Quist enjoys scuba diving and vacationing in the Caribbean. She has participated in mission trips to Cambodia and Jordan through Christ Chapel Bible Church and has been active in disaster relief ministry in hurricane-affected areas of Louisiana and Texas, reflecting her deep commitment to philanthropy and community service. Dr. Quist's philosophy centers on providing compassionate care, continuous learning, and giving back to the community through philanthropic efforts and involvement with charitable organizations. In the future, she aims to continue her commitment to excellence in women's health care, expanding her practice, and staying actively engaged in philanthropy and community service. SOURCE The Inner Circle WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Executive Change

08 Jul 2025

·ir.dermatarx.com

Dermata Receives Notice of Grant of Australian Patent for Topical Botulinum Toxin Treatment for Hyperhidrosis

- This is the Company's second granted patent for DMT410, using its Spongilla technology to topically deliver botulinum toxin for hyperhidrosis - - The Company recently entered into a Clinical Trial Collaboration Agreement with Revance to study DMT410 for the treatment of axillary hyperhidrosis - SAN DIEGO, CA / ACCESS Newswire / July 8, 2025 / Dermata Therapeutics, Inc. (NASDAQ:DRMA)(NASDAQ:DRMAW) ("Dermata" or the "Company"), a late-stage biotechnology company focusing on the treatment of medical skin diseases and aesthetic applications, today announced the Australian Patent Office has granted its patent application for its DMT410 program for the treatment of hyperhidrosis. The patent, entitled "Compositions for the treatment of skin conditions," (Australian Patent No. 2109284621) continues to strengthen Dermata's global intellectual property portfolio for DMT410 for the treatment of hyperhidrosis. "We are thrilled to be granted this Australian patent, a testament to our team's relentless innovation and dedication to providing patients with unique and novel treatment options," said Gerry Proehl, Dermata's Chairman, President, and CEO. "We believe this patent reinforces our commitment to pushing boundaries for standard of care for hyperhidrosis patients and delivering groundbreaking solutions that we believe can transform the lives of patients. We are excited about the opportunities the DMT410 program can bring to patients, not only for the treatment of axillary hyperhidrosis, as we have seen in our proof-of-concept study, but potentially for palmer and plantar hyperhidrosis, which remain high unmet needs for patients," Mr. Proehl added. About DMT410 DMT410 is the Company's combination treatment regimen that uses the unique mechanical features of the Company's XYNGARI™ product candidate to facilitate the intradermal delivery of botulinum toxin by topical application rather than through multiple injections with a needle. The treatment consists of an initial topical application of XYNGARI™ to the treatment area where the microscopic spicules penetrate the stratum corneum to create microchannels into the dermis allowing for the topical application and penetration of botulinum toxin. The Company has successfully completed proof-of-concept Phase 1 clinical trials using DMT410 in combination with BOTOX® for the treatment of primary axillary hyperhidrosis and for the treatment of multiple aesthetic skin conditions. Both studies showed promising efficacy results and appeared to be safe and well tolerated by patients. The Company is also planning to initiate a Phase 2a study of DMT410 (XYNGARI™ with DAXXIFY®) for the treatment of axillary hyperhidrosis. About Dermata Therapeutics Dermata Therapeutics is a late-stage biotechnology company focusing on the treatment of medical skin diseases and aesthetic applications. Dermata's lead product candidate, XYNGARI™ (formerly DMT310), is its first product candidate being developed from its Spongilla technology platform. XYNGARI™ is a once-weekly, topical product candidate derived from a naturally sourced freshwater sponge with multiple unique mechanisms of action that recently achieved positive data in a Phase 3 STAR-1 study for the treatment of moderate-to-severe acne. In addition to acne, XYNGARI™ has been studied for the treatment of psoriasis and rosacea. Dermata's second program, DMT410, uses XYNGARI™ as a new method for needle-free intradermal delivery of botulinum toxin for the treatment of multiple aesthetic and medical skin diseases and conditions. Dermata is headquartered in San Diego, California. For more information, please visit http://www.dermatarx.com/. Forward-Looking Statements Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are based on the Company's current beliefs and expectations and new risks may emerge from time to time. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions, and other factors including, but are not limited to, statements related to: expectations with regard to the timing of meetings and/or responses from submissions with regulatory bodies, including the FDA; the uncertainties inherent in clinical trials; expectations with regard to any potential partnership opportunities for any of the Company's product candidates; the Company's expectations with regard to current cash and cash equivalents and the amount of time it will fund operations; the success, cost, and timing of its product candidate DMT410 development activities and ongoing and planned clinical trials; whether the results of any planned clinical trials of DMT410 will lead to future product development; whether pending patent applications will proceed to allowance without interruption, if at all; and whether pending, accepted, or issued patents will provide adequate protection for the Company's product candidates, if approved. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval, and commercialization, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to Dermata's filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Dermata undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law. Investors: Cliff Mastricola Investor Relations cmastricola@dermatarx.com SOURCE: Dermata Therapeutics Released July 8, 2025

Clinical ResultPhase 1Phase 3

23 Jun 2025

·www.globenewswire.com

Emergent BioSolutions Secures $62.4 Million Contract Modification for BAT® [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) – (Equine)] to Bolster U.S. Biodefense Supply

GAITHERSBURG, Md., June 23, 2025 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced it has been awarded a $62.4 million contract modification from the Administration for Strategic Preparedness and Response (ASPR), a division of the United States Department of Health and Human Services (HHS) for BAT® [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) – (Equine)]. The modification has been made to the existing 10-year contract with ASPR (75A50119C00075) whereby Emergent will supply BAT®, an antitoxin used in the treatment of symptomatic botulism following suspected or confirmed exposure to botulinum neurotoxin serotypes A, B, C, D, E, F, or G in both adults and pediatric patients. “The ongoing commitment by the U.S. government to stockpile BAT® reinforces the importance of Emergent's medical countermeasures to help protect military and civilian populations,” said Paul Williams, senior vice president, head of products business, global government & public affairs at Emergent. “We are proud to harness our North American supply chain and capabilities to deliver life-saving solutions that safeguard public health and strengthen global emergency preparedness.” This update is a critical step toward preserving access to medical countermeasures to address potential biological threats from botulism. The types and quantities of products that should be maintained in a stockpile will depend on the population requiring protection, the products available for meeting the threat, as well as government resources and priorities. About BAT® [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) – (Equine)] BAT® is a mixture of immune globulin fragments indicated for the treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin serotypes A, B, C, D, E, F, or G in adults and pediatric patients. The effectiveness of BAT is based solely on efficacy studies conducted in animal models of botulism. The Warnings and Precautions for BAT include: Severe hypersensitivity reactions, including anaphylaxis, as well as delayed allergic reactions, including serum sickness may occur following BAT administration. Prepare for monitoring and management of allergic reactions. Infusion reactions. These reactions may be related to the infusion rate of BAT.Interference with blood glucose testing. Because BAT contains maltose, interference with non-glucose specific blood sugar testing systems can occur. Use glucose-specific testing systems.Transmissible infections agents. BAT is made from equine plasma and may contain infectious agents, e.g. viruses. There is no human or animal data for use of BAT during pregnancy. BAT should only be given to pregnant and nursing women if the potential benefits outweigh the potential risks. It is not known whether BAT is excreted in human milk. The safety and efficacy of BAT has not been established in pediatric and geriatric populations. Only limited safety data exists for pediatric populations. The most common adverse reactions observed in ≥5% of healthy volunteers in clinical trials were headache, nausea, pruritus, and urticaria. The most common adverse reactions reported in ≥1% of patients in a clinical study were pyrexia, rash, chills, nausea, and edema. One serious adverse reaction of hemodynamic instability was observed in one patient in the clinical study. Please see full Prescribing Information for BAT for additional safety information. About Emergent BioSolutions At Emergent, our mission is to protect and save lives. For over 25 years, we’ve been at work preparing those entrusted with protecting public health. We deliver protective and life-saving solutions for health threats like smallpox, mpox, botulism, Ebola, anthrax and opioid overdose emergencies. To learn more about how we help prepare communities around the world for today’s health challenges and tomorrow’s threats, visit our website and follow us on LinkedIn, X, Instagram, Apple Podcasts and Spotify. Safe Harbor StatementThis press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including statements regarding the development, availability, and government procurement of BAT® are forward-looking statements. We generally identify forward-looking statements by using words like “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “should,” “will,” “would,” and similar expressions or variations thereof, or the negative thereof, but these terms are not the exclusive means of identifying such statements. Forward-looking statements are based on our current intentions, beliefs, and expectations regarding future events based on information that is currently available. We cannot guarantee that any forward-looking statement will be accurate. Readers should realize that if underlying assumptions prove inaccurate or if known or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Readers are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events, or circumstances. Readers should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the U.S. Securities and Exchange Commission, when evaluating our forward-looking statements. Investor Contact:Richard S. LindahlExecutive Vice President, CFOlindahlr@ebsi.com Media Contact:Assal HellmerVice President, Communicationsmediarelations@ebsi.com

Clinical Study

100 Deals associated with Onabotulinumtoxin A

External Link

KEGG	Wiki	ATC	Drug Bank
D08957	Onabotulinumtoxin A	M03AX01	DB00083

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Masticatory Muscles, Hypertrophy Of	China	Allergan, Inc.	03 Jun 2024
Dystonia	United States	AbbVie, Inc.	22 Aug 2022
Neurogenic detrusor overactivity	United States	AbbVie, Inc.	22 Aug 2022
Urinary Incontinence	United States	AbbVie, Inc.	22 Aug 2022
Dysphonia	Japan	GSK Plc	25 May 2018
Forehead lines	United States	AbbVie, Inc.	02 Oct 2017
Bladder dysfunction	United States	AbbVie, Inc.	04 Apr 2017
Lateral Canthal Lines	United States	AbbVie, Inc.	11 Sep 2013
Limb spasticity	United States	AbbVie, Inc.	09 Mar 2010
Equinus Deformity	Japan	Allergan, Inc.	21 Jan 2009
Hyperhidrosis	Japan	Allergan, Inc.	21 Jan 2009
Migraine Disorders	Japan	-	21 Jan 2009
Skin Diseases	Japan	Allergan, Inc.	21 Jan 2009
Urinary Bladder, Neurogenic	Japan	Allergan, Inc.	21 Jan 2009
Urinary Bladder, Overactive	Japan	Allergan, Inc.	21 Jan 2009
Cervical Dystonia, Primary	Japan	GSK Plc	03 Oct 2005
Muscle Spasticity	-	Genesis Healthcare, Inc.	03 Oct 2005
Primary Axilary Hyperhidrosis	United States	AbbVie, Inc.	19 Jul 2004
Strabismus	United States	AbbVie, Inc.	19 Jul 2004
Blepharospasm	China	Allergan Pharmaceuticals Ireland ULC	22 Apr 2003

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Migraine With Aura	Phase 3	United States	AbbVie, Inc.	05 Nov 2021
Migraine With Aura	Phase 3	Canada	AbbVie, Inc.	05 Nov 2021
Migraine With Aura	Phase 3	Czechia	AbbVie, Inc.	05 Nov 2021
Migraine With Aura	Phase 3	Germany	AbbVie, Inc.	05 Nov 2021
Migraine With Aura	Phase 3	Israel	AbbVie, Inc.	05 Nov 2021
Migraine With Aura	Phase 3	Poland	AbbVie, Inc.	05 Nov 2021
Migraine With Aura	Phase 3	Spain	AbbVie, Inc.	05 Nov 2021
Migraine With Aura	Phase 3	Sweden	AbbVie, Inc.	05 Nov 2021
Migraine With Aura	Phase 3	United Kingdom	AbbVie, Inc.	05 Nov 2021
Migraine Without Aura	Phase 3	United States	AbbVie, Inc.	05 Nov 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04609020 (CTgov)	Phase 4	Skin Diseases \| Wrinkling of skin	64	Lidocaine+BOTOX	gttzzgcylq(qukmpvmkjc) = hqvfuhwcaf mmsxyjnyjt (kgkgywmfmb, 23.61) View more	-	17 Jun 2025
NCT04965311 (CTgov)	Phase 2	Pancreatic Fistula \| Pancreatic Cancer	4	Botulinum Toxin Type A	ncjdwwuuey = upsafozshi ttbbhsixdx (gdyfbpbgnf, tcjdqxpxns - tncisoaddl) View more	-	13 May 2025
NCT04073303 (CTgov)	Phase 3	-	377	Placebo	cwfqxmmnbf = pnietujvmo pfctoeptbv (itanuxzpsd, xhpprylymw - inkmuhilsd) View more	-	06 May 2025
P9-2.012 (AAN2025)	Not Applicable	Migraine Disorders \| Dystonic Disorders	-	Botulinum Neurotoxin (CD+migraine/headache patients)	mpmdhliqpu(fxumnqqvlu) = pgeiakeluu qdrozvjhfd (sfxoqvakqp )	-	07 Apr 2025
P9-2.012 (AAN2025)	Not Applicable	Migraine Disorders \| Dystonic Disorders	-	Botulinum Neurotoxin (CD+CM patients)	mpmdhliqpu(fxumnqqvlu) = dsybfhmccj qdrozvjhfd (sfxoqvakqp )	-	07 Apr 2025
NCT04171531 (MUSA, CTgov)	Phase 3	Urinary Incontinence, Stress \| Urinary Incontinence, Urge	150	Mid-urethral sling	mcfxjojngn(vxhflebhjy) = mprorureqf cfiwxjbhol (asyfsjeain, inewdztxpq - xjqeofbigv) View more	-	20 Mar 2025
NCT05308979 (CTgov)	Phase 4	Pollakisuria \| Urinary Incontinence, Urge \| Overactive bladder syndrome	116	OnabotulinumtoxinA 100 UNT [Botox] (1 Injection Site)	thqfxkmiwf(tnxkcgvzbc) = hsmegygkav nneoohdtao (lvuauqbcyb, 26.25) View more	-	14 Feb 2025
NCT05308979 (CTgov)	Phase 4		116	OnabotulinumtoxinA 100 UNT [Botox] (10 Injection Sites)	thqfxkmiwf(tnxkcgvzbc) = hruwxbmano nneoohdtao (lvuauqbcyb, 24.92) View more	-	14 Feb 2025
NCT06080438 (CTgov)	Phase 4	Excessive tearing \| Blepharospasm	2	Botulinum toxin	zpxlcdjqag(cknzmiixno) = zbbtpzlfiz cpgjpjtizu (doqbovzgvu, 0.69) View more	-	05 Dec 2024
NCT05134649 (CTgov)	Phase 3	Platysma Prominence	292	OnabotulinumtoxinA	nxopyrksoi(iwjbsubjex) = adsvmrnfdb fhcfoqvwec (gkctmfyown, lfwfeosxsc - ugdhymjmmu) View more	-	05 Dec 2024
NCT03456154 (Pubmed \| J Dent)	Phase 4	Sleep Bruxism \| Myalgia	-	botulinum toxin-a (Occlusal splint)	gwnammbtiy(bgiiqxvfyl): OR = 0.29 (95% CI, 0.11 - 0.82)	Positive	01 Dec 2024
NCT03456154 (Pubmed \| J Dent)	Phase 4	Sleep Bruxism \| Myalgia	-	Botulinum toxin-A	gwnammbtiy(bgiiqxvfyl): OR = 0.29 (95% CI, 0.11 - 0.82)	Positive	01 Dec 2024
NCT04949399 (CTgov)	Phase 3	Platysma Prominence	408	Placebo (Placebo)	smkouccwfu = sqsrnuysmk mkuvhuknlr (rhobfukwep, chkmjsdebh - sdsmynymcm) View more	-	20 Nov 2024
NCT04949399 (CTgov)	Phase 3	Platysma Prominence	408	OnabotulinumtoxinA (BOTOX)	smkouccwfu = bvtnijdzty mkuvhuknlr (rhobfukwep, ccdhsyhano - buhwqlwhdh) View more	-	20 Nov 2024

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