Drugs / Botulinum toxin
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Botulinum toxin

Protein / enzyme biologic

Developed for
stroke disorder · atrial fibrillation · cervical dystonia · compartment syndrome · eyelid disorder · movement disorder · spastic hemiplegia · traumatic brain injury
+44 more · anismus · arthropathy, erosive · benign essential blepharospasm · bruxism · carpal displacement · cerebral palsy · cerebral palsy spastic hemiplegic · chronic pain syndrome · clubfoot · congenital contractures · dystonic disorder · esophageal disorder · excessive tearing · eye adnexa disorder · eyelid degenerative disorder · gingival overgrowth · hemiplegia · interstitial cystitis · keloid formation · masticatory muscles, hypertrophy of · osteoarthritis, knee · overactive bladder · Parkinson disease · pelvis syndrome · reactive cutaneous fibrous lesion · rotator cuff syndrome · scleroderma · seborrheic dermatitis · spastic diplegia · strabismus · ventricular tachycardia · vulvar disease · vulvodynia · cardiac rhythm disease · carpal tunnel syndrome · constipation disorder · diabetes mellitus · essential tremor · paroxysmal atrial fibrillation · peripheral neuropathy · persistent atrial fibrillation · Raynaud disease · rectal disorder · ulcer of lower limbs
Investigated by
Allergan · Meshalkin Research Institute of Pathology of Circulation · Assistance Publique Hopitaux De Marseille · Galderma R&D · Hospices Civils de Lyon · University of Miami
+45 more · 375th Medical Group, Scott Air Force Base · Albany Medical College · American Urogynecologic Society · Asir John Samuel · Baylor College of Medicine · Cairo University · Canisius-Wilhelmina Hospital · Centre Hospitalier Universitaire de Nice · Chang Gung Memorial Hospital · Donders Centre for Cognitive Neuroimaging · Fondazione Don Carlo Gnocchi ETS · Fondo Nacional de Desarrollo Científico y Tecnológico, Chile · Foundation University Islamabad · Fox, Donald Munro, M.D., P.C. · HCA International Limited · Hadassah Medical Organization · Henry Ford Health System · HillMed Inc. · Icahn School of Medicine at Mount Sinai · Instituto Nacional de Rehabilitación Pedro Aguirre Cerda · Karen Noblett · King Abdulaziz Medical City · Mackay Medical College · Mayo Clinic · NYU Langone Health · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · National Taiwan University Hospital · Promobilia Foundation · Rabin Medical Center · Radboud University Medical Center · Ramsay Santé · Rhode Island Hospital · Rigshospitalet, Denmark · St Joseph University, Beirut, Lebanon · Uniformed Services University of the Health Sciences · Universidad de los Andes, Chile · University Hospital, Grenoble · University Hospital, Rouen · University of Houston · University of Ioannina · University of Texas Southwestern Medical Center · Vastra Gotaland Region · Versailles Hospital · Walter Reed National Military Medical Center · Zonguldak Bulent Ecevit University

Regulatory milestones approvals, filings & regulatory actions · 4 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed detrusor sphincter dyssynergia 1 milestone
Filed US (FDA) BOTOX detrusor sphincter dyssynergia 2020-06-22

“FDA has accepted the company's supplemental biologics license application (sBLA) to expand the BOTOX ® prescribing information” abbvie.com ↗

Filed masticatory muscles, hypertrophy of 1 milestone
Filed US (FDA) BOTOX Cosmetic masticatory muscles, hypertrophy of 2026-08-04

“FDA has accepted for review its supplemental Biologics License Application (sBLA) for BOTOX® Cosmetic” abbvie.com ↗

Rejected Indication not stated 2 milestones
Rejected (CRL) US (FDA) — glabellar lines 2026-04-23

“received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for trenibotulinumtoxinE” abbvie.com ↗

Rejected (CRL) US (FDA) — glabellar and lateral canthal lines 2023-10-03

“Galderma has confirmed receipt from the FDA of a Complete Response Letter related to its Biologics License Application for liquid botulinum toxin type A (QM-1114)” ipsen.com ↗

Trials 47

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 02 trials
Phase 0 NCT05062902 Sep 2025 → Aug 2027 expected chronic pain syndrome, interstitial cystitis, pelvis syndrome HillMed Inc. Not yet recruiting No outcome recorded
Phase 0 NCT04523506 May 2020 → Apr 2021 scleroderma University of Texas Southwestern Medical Center Completed No outcome recorded
Phase 18 trials
Phase 1 NCT06796985 Feb 2025 → Mar 2027 expected — University of Miami Recruiting No outcome recorded
Phase 1 NCT04630873 Nov 2020 → Aug 2025 overdue spastic hemiplegia University of Ioannina Recruiting No outcome recorded
Phase 1 NCT04030767 Sep 2019 → Sep 2020 gingival overgrowth Cairo University Unknown No outcome recorded
Phase 1 NCT02139319 Mar → Jul 2014 osteoarthritis, knee Galderma R&D Completed No outcome recorded
Phase 1 NCT02003027 Jun 2013 → Dec 2015 — Meshalkin Research Institute of Pathology of Circulation Unknown No outcome recorded
Phase 1 NCT02003001 Jun 2013 → Mar 2016 ventricular tachycardia Meshalkin Research Institute of Pathology of Circulation Unknown No outcome recorded
Phase 1 NCT01682733 Aug 2012 → Dec 2014 obesity disorder Mayo Clinic Completed No outcome recorded
Phase 1 NCT00767546 May 2009 → Aug 2010 Parkinson disease, seborrheic dermatitis Rabin Medical Center Unknown No outcome recorded
Phase 26 trials · 1 missed
Phase 2 NCT04409600 Nov 2020 → Dec 2024 compartment syndrome Walter Reed National Military Medical Center Completed No outcome recorded
Phase 2 NCT02982434 Sep 2016 → Dec 2017 atrial fibrillation, ischemic disease Meshalkin Research Institute of Pathology of Circulation Unknown No outcome recorded
Phase 2 NCT02623829 Dec 2015 → Mar 2019 keloid formation Icahn School of Medicine at Mount Sinai Completed No outcome recorded
Phase 2 NCT02867787 Mar 2014 → Sep 2016 rotator cuff syndrome Versailles Hospital Unknown No outcome recorded
Phase 2 NCT01955174 Aug 2013 → May 2017 esophageal disorder Hospices Civils de Lyon Completed Missed primary
Phase 2 NCT00973999 Sep 2009 → Sep 2011 traumatic brain injury HCA International Limited Withdrawn No outcome recorded
Phase 2/35 trials
Phase 2/3 NCT05478551 Jun 2022 → Dec 2026 expected reactive cutaneous fibrous lesion Henry Ford Health System Active not recruiting No outcome recorded
Phase 2/3 NCT03339921 Dec 2018 → May 2020 compartment syndrome 375th Medical Group, Scott Air Force Base Terminated No outcome recorded
Phase 2/3 NCT02617069 Sep 2015 → Mar 2016 atrial fibrillation Meshalkin Research Institute of Pathology of Circulation Unknown No outcome recorded
Phase 2/3 NCT01780636 Jan 2013 → Jan 2014 anismus Karen Noblett Terminated No outcome recorded Stop: Enrollment
Phase 2/3 NCT00133861 Apr 2005 → Jun 2008 cerebral palsy Hospices Civils de Lyon Completed No outcome recorded
Phase 37 trials · 1 met primary
Phase 3 NCT05998187 Apr 2025 → Jun 2027 expected — University Hospital, Rouen Recruiting No outcome recorded
Phase 3 NCT05008731 Jul 2024 → Feb 2026 congenital contractures Ramsay Santé Terminated No outcome recorded Stop: Enrollment
Phase 3 NCT05990881 Aug 2023 → Dec 2025 overdue carpal displacement, salivary substance, Clostridium botulinum type, thumb deformity Rhode Island Hospital Recruiting No outcome recorded
Phase 3 NCT04249687 Feb → Sep 2020 eyelid disorder Galderma R&D Completed Met primary
Phase 3 NCT04579419 Nov 2019 → Aug 2020 — King Abdulaziz Medical City Completed No outcome recorded
Phase 3 NCT01829763 Apr 2013 → Apr 2015 hemiplegia Assistance Publique Hopitaux De Marseille Unknown No outcome recorded
Phase 3 NCT01422161 Apr 2010 → Oct 2015 stroke disorder NYU Langone Health Completed No outcome recorded
Phase 47 trials
Phase 4 NCT06411028 Jan 2025 → May 2027 expected dystonic disorder Radboud University Medical Center Recruiting No outcome recorded
Phase 4 NCT06734598 Dec 2024 → Nov 2025 overdue head and neck cancer National Taiwan University Hospital Recruiting No outcome recorded
Phase 4 NCT06080438 Nov 2022 → Jul 2024 excessive tearing, eyelid disorder University of Miami Terminated No outcome recorded Stop: Enrollment
Phase 4 NCT04829565 Sep 2021 → May 2025 overdue arthropathy, erosive Centre Hospitalier Universitaire de Nice Active not recruiting No outcome recorded
Phase 4 NCT03701919 Jan 2019 → Nov 2022 — Albany Medical College Completed No outcome recorded
Phase 4 NCT02786550 Jun 2016 → Jun 2018 eyelid degenerative disorder Chang Gung Memorial Hospital Unknown No outcome recorded
Phase 4 NCT00119886 Apr 2005 → Jun 2008 vulvar disease, vulvodynia Rigshospitalet, Denmark Unknown No outcome recorded
Phase not applicable12 trials · 1 met primary
— NCT07180394 Sep 2025 → Aug 2030 expected strabismus Foundation University Islamabad Not yet recruiting No outcome recorded
— NCT07025642 Jul 2025 → May 2026 overdue overactive bladder Mackay Medical College Recruiting No outcome recorded
— NCT06733025 Jan 2025 → Jan 2029 expected spinal cord injury, stroke disorder, traumatic brain injury Vastra Gotaland Region Recruiting No outcome recorded
— NCT06593821 Apr 2023 → Jan 2024 bruxism, masticatory muscles, hypertrophy of Zonguldak Bulent Ecevit University Completed Met primary
— NCT07124806 Jul → Nov 2022 movement disorder, spastic hemiplegia, stroke disorder Universidad de los Andes, Chile Completed No outcome recorded
— NCT04177186 Oct 2020 → Aug 2021 cerebral palsy spastic hemiplegic, spastic diplegia Asir John Samuel Unknown No outcome recorded
— NCT03938363 Oct 2019 → Jun 2022 benign essential blepharospasm, cervical dystonia University Hospital, Grenoble Completed No outcome recorded
— NCT03836638 May 2019 → Dec 2020 salivary substance, Clostridium botulinum type St Joseph University, Beirut, Lebanon Unknown No outcome recorded
— NCT03247868 Mar 2016 → Mar 2018 cervical dystonia Fondazione Don Carlo Gnocchi ETS Unknown No outcome recorded
— NCT02244671 Jan 2014 → Jan 2018 eye adnexa disorder Fox, Donald Munro, M.D., P.C. Completed No outcome recorded
Comparator or background therapy20 trials
Phase 1 NCT04439825 Comparator Jul → Sep 2020 — DeNova Research Completed No outcome recorded
Phase 1/2 NCT02015039 Background Dec 2013 → Sep 2016 focal, segmental or multifocal dystonia National Institute of Neurological Disorders and Stroke (NINDS) Completed No outcome recorded
Phase 2 NCT02008448 Comparator Jun 2013 → Dec 2015 persistent atrial fibrillation Meshalkin Research Institute of Pathology of Circulation Unknown No outcome recorded
Phase 2 NCT02008461 Comparator Jun 2013 → Dec 2015 cardiac rhythm disease Meshalkin Research Institute of Pathology of Circulation Unknown No outcome recorded
Phase 2 NCT02002923 Comparator Jun 2013 → Jun 2015 paroxysmal atrial fibrillation, persistent atrial fibrillation Meshalkin Research Institute of Pathology of Circulation Unknown No outcome recorded

News releases announcing trial results or a regulatory action · 89

DateIssuerRelease
2026-09-17 Merz Therapeutics GmbH Regulatory Merz Therapeutics Receives EU/EEA Approval for XEOMIN ® for the Treatment of Pediatric Spasticity associated with Pes Equinus merztherapeutics.com ↗
Approval expands XEOMIN use to include the symptomatic treatment of spasticity associated with pes equinus in children and adolescents with cerebral palsy aged 2 to 17 years.
2026-09-09 AEON Biopharma, Inc. Results AEON Announces Positive Pilot Forced Degradation Results Supporting Analytical Comparability of ABP-450 to BOTOX® aeonbiopharma.com ↗
Under thermal stress, both ABP-450 and BOTOX ® lost potency at comparable rates.
2026-08-19 AEON Biopharma, Inc. Results AEON Reports Expanded Structural Data Supporting Molecular Similarity of ABP-450 to BOTOX® aeonbiopharma.com ↗
The expanded primary structure analysis achieved 98% sequence coverage of the active botulinum neurotoxin and demonstrated 100% amino acid identity across every region analyzed.
2026-08-04 AbbVie Regulatory Allergan Aesthetics Announces U.S. FDA Acceptance of Supplemental Biologics License Application for BOTOX® Cosmetic for Masseter Muscle Prominence abbvie.com ↗
2026-07-09 Ipsen Results Dysport® is the first botulinum toxin to achieve positive topline Phase III results in both episodic and chronic migraine. ipsen.com ↗
The E-BEOND results represent the first Phase III trial in which a botulinum toxin has demonstrated statistically significant efficacy in episodic migraine.
2026-05-19 Ipsen Results Ipsen announces late-breaking data from first head-to-head study comparing Dysport® and Botox® in adults with upper limb spasticity ipsen.com ↗
The DIRECTION trial results show the safety profile for Dysport® (abobotulinumtoxinA) was non-inferior to Botox® (onabotulinumtoxinA) in adult patients with upper limb spasticity
2026-05-12 Merz Therapeutics GmbH Results Merz Therapeutics’ Activities at ISPRM 2026 Highlight the Importance of Patient-Centric Management in Upper and Lower Limb Spasticity: From Goal Setting to Optimal Dosing for Better Patient Outcomes merztherapeutics.com ↗
Updated analysis indicates that optimizing botulinum toxin dosing over multiple injection cycles may be an important factor in improving outcomes in people living with limb spasticity, with available clinical data suggesting support for flexible, individualized dosing with incobotulinumtoxinA (XEOMIN ® )
2026-04-13 Cutia Therapeutics(Wuxi)Co.,Ltd Results VOLUNTARY ANNOUNCEMENT - COMPLETION OF PHASE III CLINICAL TRIAL OF CU-20101 (BOTULINUM TOXIN TYPE A FOR INJECTION) FOR IMPROVING MODERATE TO SEVERE GLABELLAR LINES IN CHINA cutiatx.com ↗
COMPLETION OF PHASE III CLINICAL TRIAL OF CU-20101 (BOTULINUM TOXIN TYPE A FOR INJECTION) FOR IMPROVING MODERATE TO SEVERE GLABELLAR LINES IN CHINA
2026-03-30 AbbVie Results Allergan Aesthetics Releases Findings on the Safety and Efficacy of Repeat TrenibotE Treatments and Data on Medical Weight Loss Aesthetics Patient Behaviors at the 2026 American Academy of Dermatology Meeting (AAD) abbvie.com ↗
TrenibotE is an investigational first-in-class botulinum neurotoxin serotype E characterized by rapid results, as early as 8 hours after administration (earliest assessment time), and shorter duration of effect of 2-3 weeks.
2026-03-26 AbbVie Results Allergan Aesthetics Reinforces Scientific Differentiation and Leadership with 21 Evidence-Based E-Posters at the 2026 Aesthetic & Anti-Aging Medicine World Congress (AMWC) abbvie.com ↗
2026-01-26 Merz Therapeutics GmbH Regulatory Merz Therapeutics Submits Application for New Indication of XEOMIN ® in Pediatric Spasticity in Europe merztherapeutics.com ↗
Merz Therapeutics, a leading player in neurology-focused specialty pharma, today announced that it has completed the regulatory submission for XEOMIN® (incobotulinumtoxinA) for the treatment of spasticity of the lower and upper limb in children and adolescents aged 2–17 years in the European Union (EU) and European Economic Area (EEA).
2026-01-22 Galderma R&D Results IMCAS 2026: Galderma showcases the latest scientific advances behind the industry’s broadest injectable aesthetics portfolio galderma.com ↗
New data on the innovative neuromodulator Relfydess™ (RelabotulinumtoxinA) will reinforce its rapid onset as early as Day 1 and sustained efficacy through six months for frown lines and crow’s feet12

All press releases naming this drug 151 releases

DateIssuerRelease
Show all 151 releases opens the full record — a long page

Evidence & citations 18 cited values

Every value below carries the sentence it was read from. 71 sources stand behind the page.

FieldValueCited text
Known as Botulinum Toxin “The aim of this prospective non-randomized study was to assess the efficacy and safety of endomyocardial botulinum toxin injection in left ventricle for preventing episodes of VT Storm.” NCT02003027 ↗
62

“While Botulinum toxin(BoNT) injections are widely used for focal spasticity, surgical interventions remain underutilized despite promising long-term outcomes.” NCT06733025 ↗

“Injection of the botulinum toxin is performed in main anatomical zones of ganglionated plexuses of left atrium using Myostar catheter (Biosense Webster).” NCT02008448 ↗

“This project aims to explore the therapeutic effect of Botulinum toxin (Botox) injection to the masticatory muscles in the above-mentioned patients.” NCT06734598 ↗

“Local injection of Botulinum toxin (BTx) has become a mainstay of the treatment of focal spasticity, particularly in post-stroke patients.” NCT01829763 ↗

“The investigators assume that intramuscular injection of botulinum toxin is effective in the treatment of tendinopathy rotator cuff.” NCT02867787 ↗

“Botulinum toxin produces partial chemical denervation of the muscle resulting in localized reduction in muscle activity” NCT04030767 ↗

“Botulinum toxin treatment results in a pharmacologic recession of the injected extraocular muscle” NCT07180394 ↗

“Focal injections of botulinum toxin (BoNT) are the current best therapy.” NCT02015039 ↗

“Botulinum Toxin diluted in Sodium Bicarbonate” NCT04579419 ↗

“Botulinum toxin” NCT01631604 ↗

Show 52 more sources

Known as BoNT “The purpose of this study is to evaluate if it is possible to use intravaginal high-density surface electromyography to guide Botulinum neurotoxin (BoNT) injection to treat...” NCT05062902 ↗
3

“While Botulinum toxin(BoNT) injections are widely used for focal spasticity, surgical interventions remain underutilized despite promising long-term outcomes.” NCT06733025 ↗

“Focal injections of botulinum toxin (BoNT) are the current best therapy.” NCT02015039 ↗

“Botulinum neurotoxin (BoNT) is the first-line treatment of ICD” PMID 31478151 ↗ Sep 2019

Known as BoNTA “intradetrusor injection of botulinum neurotoxin type A (BoNTA)” NCT07025642 ↗
Known as Botox “This project aims to explore the therapeutic effect of Botulinum toxin (Botox) injection to the masticatory muscles in the above-mentioned patients.” NCT06734598 ↗
6

“Botulinum toxin (BTX, brand name Botox®), produced naturally by the bacterium Clostridium botulinum and adapted for medical use” NCT03701919 ↗

“Urodynamic evaluation before and after Botulinum toxin (Botox) injection.” NCT07025642 ↗

“A single session of Botox (Botulinum toxin A) injection was performed.” NCT06583551 ↗

“one hundred units of type A botulinum toxin (Botox®, Allergan)” NCT01955174 ↗

“Botulinum Toxin commonly known as BOTOX®” NCT01422161 ↗

“Biological: Botulinum toxin(Botox)” NCT04523506 ↗

Known as Botulin toxin “patients with spastic hemiparesis which will be treated with Botulin toxin at different dilutions.” NCT04630873 ↗
Known as Botulinum neurotoxin “Botulinum neurotoxin (BoNT) is the first-line treatment of ICD” PMID 31478151 ↗ Sep 2019
4

NCT03302741 ↗

NCT06796985 ↗

NCT04439825 ↗

NCT05062902 ↗

Known as botulinum neurotoxin type A “intradetrusor injection of botulinum neurotoxin type A (BoNTA)” NCT07025642 ↗
Known as Botulinum toxin A “A single session of Botox (Botulinum toxin A) injection was performed.” NCT06583551 ↗
1

“Botulinum toxin A injection” NCT00701233 ↗

Known as Botulinum Toxin Type A “Botulinum Toxin Type A for Pain in Advanced Parkinson's Disease” NCT02472210 ↗
Known as BTX “Local injection of Botulinum toxin (BTx) has become a mainstay of the treatment of focal spasticity, particularly in post-stroke patients.” NCT01829763 ↗
3

“Botulinum toxin (BTX, brand name Botox®), produced naturally by the bacterium Clostridium botulinum and adapted for medical use” NCT03701919 ↗

“Improvement of cervical/eyelid control following botulinum toxin (BTX) injections would translate into gait changes.” PMID 38386480 ↗ Dec 2023

“Botulinum neurotoxin (BTX)” NCT03302741 ↗

Known as BTX-A “The study aimed to assess and compare the effectiveness of 4 different methods in the management bruxism: Botulinum toxin (BTX-A), dry needling (DN), pharmacological therapy...” NCT06583551 ↗
2

“OBJECTIVE: To determine the effects of botulinum neurotoxin type A (BTX-A) dilution and endplate-targeting in spastic elbow flexors.” PMID 19154823 ↗ Jan 2009

“botulinum toxin injection (BTX A)” NCT06411028 ↗

Known as Dysport “A volume of 0.5 ml of dissolved toxin, i.e., 100 u Dysport, is injected in each patient” NCT00927849 ↗
1

“Botulinum Toxin type-A (Dysport, Ipsen Ltd, Slough, Berkshire)” NCT00973999 ↗

Known as incobotulinumtoxin A “All patients underwent conventional CABG. After the main stage of the surgery botulinum toxin (Xeomin, incobotulinumtoxin A, Merz Pharma GmbH \& Co KGaA, Germany; 50 U/1 mL at...” NCT01842529 ↗
Known as Intramuscular injection of Botulinum toxin A. (BoNT-A) “Intramuscular injection of Botulinum toxin A. (BoNT-A)” NCT06583551 ↗
Known as Xeomin “Patients with history of paroxysmal atrial fibrillation and indication for coronary artery bypass graft surgery were randomized to botulinum toxin (Xeomin, Merz, Germany; 50...” PMID 26486855 ↗ Oct 2015
Action Inhibit “botulinium toxin, which inhibitis acetyl choline realese” NCT00767546 ↗
Modality Protein / enzyme biologic “Biological: botulinum toxin injection” NCT01842529 ↗
Route Other “after local injection with Botox” NCT00119886 ↗