Delving into the Latest Updates on Botulinum toxin type A(HSM) with Synapse

Overview

Basic Info

Drug Type

Toxin

Synonyms

Botulinum Toxin Type A, 注射用重组A型肉毒毒素

+ [2]

Target

SNAP25

Action

inhibitors

Mechanism

SNAP25 inhibitors(Synaptosomal-associated protein 25 inhibitors)

Therapeutic Areas

Skin and Musculoskeletal DiseasesNervous System Diseases

Active Indication

Upper limb spasticityGlabellar frown lines

Inactive Indication-

Originator Organization

JHM BioPharma (Tonghua) Co. , Ltd.

Active Organization

JHM BioPharma (Tonghua) Co. , Ltd.

Inactive Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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Study Type: This is a multicenter, triple-blind, randomized controlled trial.
Purpose: The goal of this clinical trial is to compare the effectiveness and safety of all five commercially available Botulinum Neurotoxin Type A (BoNT-A) products for treating glabellar rhytides, commonly known as frown lines. This study is designed to provide comprehensive data on how these treatments compare in terms of improving frown lines and the duration of their effects.
Main Questions the Study Aims to Answer:
Which BoNT-A product provides the longest lasting effect on reducing glabellar rhytides? How do these products compare in terms of safety and the occurrence of side effects?
Participant Tasks:
Women aged 18 years or older with moderate to severe glabellar lines will participate.
Participants will receive injections of a BoNT-A product into specific facial muscles.
They will need to take weekly photographs using their smartphones to document changes in their frown lines.
These photos will be securely sent to our research team for analysis. Participants will complete questionnaires at the start and end of the study to assess their satisfaction, quality of life, and any changes in their condition.
Comparison Group:
Researchers will compare participants receiving different types of BoNT-A products to see which one is more effective at reducing frown lines and maintaining these effects over time.
The safety profiles of these products will also be compared to determine which has the fewest and least severe side effects.
This study aims to fill important gaps in our understanding of Botulinum Neurotoxin Type A treatments, guiding more effective clinical decisions and improving patient outcomes.

Start Date01 Jan 2025

Sponsor / Collaborator-

NCT06584240

/ Not yet recruitingPhase 1/2

A Phase Ib/II Clinical Study to Evaluate the Safety and Efficacy of Recombinant Botulinum Toxin Type a (JHM03) in Adult Patients with Upper Limb Spasticity

This is a phase Ib/II clinical study to evaluate the safety and efficacy of recombinant botulinum toxin type A（JHM03）in adult patients with upper limb spasticity. The purpose of this study was to observe efficacy and safety of JHM03 compared with placebo in adult patients with upper limb spasticity.

Start Date01 Oct 2024

Sponsor / Collaborator

JHM BioPharma (Tonghua) Co. , Ltd.

IRCT20101012004920N10

/ SuspendedPhase 1IIT

Safety study on botulinum toxin type A of Plasma Darman Sarve Sepid Company

Start Date22 Sep 2024

Sponsor / Collaborator-

100 Clinical Results associated with Botulinum toxin type A(HSM)

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100 Translational Medicine associated with Botulinum toxin type A(HSM)

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100 Patents (Medical) associated with Botulinum toxin type A(HSM)

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2,458

Literatures (Medical) associated with Botulinum toxin type A(HSM)

01 Jul 2025·The Ocular Surface

Impact of botulinum toxin type A on ocular pain with neuropathic features

Article

Author: Lee, Wendy W ; Locatelli, Elyana V T ; Huang, Jaxon J ; Reyes, Nicholas ; Betz, Jason D ; Kantor, Nicole B ; Huang, Jordan J ; Galor, Anat ; Felix, Elizabeth R

PURPOSETo investigate the impact of botulinum toxin type A (BoNT-A) on neuropathic/nociplastic ocular pain (NOP) and identify predictors of patient outcomes.METHODSA retrospective study of individuals with NOP symptoms (light sensitivity, wind/air sensitivity, persistent pain despite dry eye treatment) who received ≥1 BoNT-A injection. Primary outcome measures included if (responders vs. non-responders) and to what degree (none vs. mild vs. moderate vs. marked) individuals experienced pain improvement 4-6 weeks post-injection. Demographics and clinical exam information was compared between the groups.RESULTS27 individuals received BoNT-A for NOP symptoms. 74 % (n = 20) reported an improvement in pain and were classified as responders. Among responders, the degree of benefit varied, with 25 % reporting mild, 45 % moderate, and 30 % marked pain improvement. Improvements in light sensitivity (37 %), wind/air sensitivity (33 %), and quality of life (QoL) (59 %) were reported by fewer individuals. 80 % of responders and 0 % of non-responders reported QoL improvements afer BoNT-A. In a multivariable model that examined predictors of response (none to marked, 0-3), the presence of fibromyalgia (FM) (β = 0.50; p = 0.004) portended a better response, while shooting pain (β = -0.47; p = 0.007) portended a worse response to BoNT-A, (full model r² = 0.53; p < 0.001). Degree of pain improvement significantly correlated with improvements in light sensitivity, wind/air sensitivity, and QoL (ρ range: 0.42-0.63; p < 0.05).CONCLUSIONAfter BoNT-A, most individuals reported improved ocular pain and QoL, while fewer noted improved light and wind/air sensitivity. Some systemic and ocular factors predicted treatment response and may thus guide treatment.

06 Mar 2025·S.S. Korsakov Journal of Neurology and Psychiatry

Comparative analysis of the effectiveness of Botulinum toxin type A — hemagglutinin preparations of the Relatox and Botox complex in the treatment of patients with primary idiopathic blepharospasm

Article

Author: Gusev, V.V. ; Lvova, O.A. ; Makarov, E.A.

Objective. To analyze the effectiveness of Relatox (Botulinum toxin type A — hemagglutinin complex) in comparison with Botox in the treatment of primary idiopathic blepharospasm. Material and methods. The study included clinical data for 21 patients with blepharospasm who were treated by botulinum therapy with Botox and Relatox for 3 years. The research method is a one-step retrospective analysis of medical data. Injections were carried out with a 3-month interval. On the 6th cycle, the drug was switched to Relatox. The clinical efficacy of the drugs was assessed using an 8-point Jankovich evaluation scale: the average values before the injection and 14 days after it were compared for each procedure. Results. Mean Jankovich scale scores decreased 2.5-fold for all cycles by the second week after the procedure (4.95 pre-injection vs. 1.8 post-injection), and the mean paired Student’s T-criterion for all injections was 7.14 (with a critical value of 2.021 and a significance level of p=0.05). The mean paired Student’s T-criterion for Botox was –6.63 and for Relatox –7.5 (with a critical value of 2.021 and a significance level of p=0.05), indicating a high efficacy of both drugs, slightly higher for Relatox. Conclusion. A consistent trend of increasing efficacy with regular botulinum toxin injections and greater efficacy of Relatox compared to Botox in the treatment of patients with primary idiopathic blepharospasm has been demonstrated.

01 Mar 2025·American Journal of Physical Medicine & Rehabilitation

Focal Shock Waves Increase Efficacy and Prolong the Effect of Botulinum Toxin on Spasticity in Patients With Brain Injury From Stroke and Multiple Sclerosis

Article

Author: Hernández, Jaime ; Marrero, Isabel ; Saavedra, Pedro ; Déniz, Antonio

ObjectiveThe aim of the study is to assess the effects on spasticity reduction of the association between focal extracorporeal shock wave therapy and botulinum toxin type A, versus the toxin only in brain injury patients.DesignEighteen patients were included. The study had two phases: the first phase was observational, and botulinum toxin type A was used. The second was a prospective, deliberate intervention phase in which the toxin was injected and focal extracorporeal shock wave treatment was added (1 sessions/week, for 3 wks). The patients were followed up in the 1st, 4th, and 6th month, the Ashworth Scale criterion was applied, and for those with lower limb involvement and changes in walking, the 10-meter walk test was used.ResultsPatients treated with toxin only showed a statistically significant improvement in spasticity, with 1 point on the Ashworth Scale from week 5, which disappeared at week 17. However, the combined therapy reduced spasticity by 2 points from week 1 to week 25 (P < 0.001), with a faster result in the 10-meter gait test (P = 0.004).ConclusionsCombined and simultaneous treatment with botulinum toxin and focal extracorporeal shock wave reduced spasticity in a more effective and prolonged way than treatment with botulinum toxin only.

100 Deals associated with Botulinum toxin type A(HSM)

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External Link

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Upper limb spasticity	Phase 2	China	JHM BioPharma (Tonghua) Co. , Ltd.	13 Sep 2024
Glabellar frown lines	Phase 2	China	JHM BioPharma (Tonghua) Co. , Ltd.	18 Jan 2024

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Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


P11-12.007 (AAN2023)	Not Applicable	Trigeminal Neuralgia	5	Botulinum toxin type A	vxqbcqaphs(tbgfxyuhch) = seen only in 1 patient after the first injection vaqxcnimex (hsbwveggtj )	Positive	25 Apr 2023
MDS2022	Not Applicable	Neuralgia, Postherpetic \| Trigeminal Neuralgia	19	Botulinum Toxin Type A	mmhhfjpcur(seprrgdtnu) = in 1 case ypavxjdhwn (fdgmkrvdqb )	-	15 Sep 2022
ARVO2017	Not Applicable	Blepharospasm	-	botulinum toxin type A (Normal volunteers)	(hcvmjzhbpc) = llnweoqlhy upiuvaxghd (xhjfevmrtx )	Positive	07 May 2017
ARVO2017	Not Applicable	Blepharospasm	-	botulinum toxin type A (Patients with blepharospasm)	(hcvmjzhbpc) = tmyioyzodk upiuvaxghd (xhjfevmrtx )	Positive	07 May 2017
MDS2016	Not Applicable	Essential Tremor	21	Botulinum toxin type A	rmizfflqgv(pqtgvxsymh) = uakyyakpwr qplpxutnzm (spsejigltf ) View more	-	19 Jun 2016
MDS2016	Not Applicable	Blepharospasm	252	Botulinum toxin type A	zmyaqsvxez(bhxzpcqfvc): RR = 5.77 (95% CI, 1.82 - 18.34) View more	Positive	19 Jun 2016
MDS2016	Not Applicable	Blepharospasm	252	Placebo		Positive	19 Jun 2016
P01.230 (AAN2012)	Not Applicable	Influenza-like symptoms	218	Botulinum Toxin Type A	ocolpzclua(qhdnvpooma) = FLS were reported by 20 (9.2%) patients kpxaqnxsdy (xckmvdvjnm ) View more	Positive	23 Apr 2012
ARVO2012	Not Applicable	Movement Disorders	334	Botulinum toxin type A	ruioquvtvw(ybvqhzhsak) = ildxaeitpc fywnmqncvx (krmpgtriey ) View more	-	01 Mar 2012
ARVO2008	Not Applicable	Hemifacial Spasm	31	Botulinum toxin type A	(swyaoojohu) = hpelhvwaan pibszwzwth (dzvorqgoek ) View more	-	01 May 2008
ARVO2006	Not Applicable	Migraine Disorders	17	Botulinum toxin type A	(wtswrjoofq) = There were no reported adverse events caxscmmhkl (gispwadzyv ) View more	Positive	01 May 2006
ARVO2006	Not Applicable	Lateral Canthal Lines	13	Botulinum Toxin Type A	(ozyvvtlnqa) = None of the patients developed dry eye symptoms 1 week and 1 month after botulinum toxin injection. Only one patient reported dry eye symptoms at 4 months follow-up. rjtnqxohfo (auvjrfpzgl )	Positive	01 May 2006
ARVO2006	Not Applicable	Lateral Canthal Lines	13	Unpreserved Saline		Positive	01 May 2006

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