Delving into the Latest Updates on Atropine Sulfate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

(±)-atropine, (±)-hyoscyamine, Atropin Sulfate

+ [51]

Target

mAChRs

Action

antagonists

Mechanism

mAChRs antagonists(Muscarinic acetylcholine receptor antagonists)

Therapeutic Areas

Nervous System DiseasesCardiovascular DiseasesEye Diseases+ [1]

Active Indication

MyopiaHeart ArrestMushroom Poisoning+ [9]

Inactive Indication

Organophosphate Poisoning

Originator Organization

Santen Pharmaceutical Co., Ltd.

Active Organization

Bausch & Lomb, Inc.Vyluma, Inc.Beijing Lepu Pharmaceutical Technology Co., Ltd.

+ [30]

Inactive Organization

Hyperion DeFi, Inc.

Rafa Laboratories Ltd.

Tianjin Kingyork Group Hebei Univision Pharmaceutical Co., Ltd.

+ [7]

License Organization

Jacobson Pharma Corp. Ltd.

Hyperion DeFi, Inc.

Laboratoires Théa SAS

+ [9]

Drug Highest PhaseApproved

First Approval Date

Japan (20 Jul 1968),

CycloplegiaMydriasis

RegulationPriority Review (China)

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Structure/Sequence

Molecular FormulaC17H27NO8S

InChIKeyPVGPXGKNDGTPTD-ODJCEOKHSA-N

CAS Registry5908-99-6

Myopia, or shortsightedness, is a multifactorial disorder, governed by environmental and genetic factors.
Myopia is the most common ocular disorder worldwide with an increasing prevalence over the past few decades and affecting the quality of life and economic health of individuals worsening socio-economic problems.
Progressive myopia is nearly exclusively a condition of childhood and adolescence, as in most young adults, myopia has stabilized.
Myopia frequently appears in childhood, with a peak incidence occurring between 8 and 10 years of age.
The most used topical pharmacological intervention for managing childhood myopia progression is atropine, a non-selective muscarinic antagonist, which has been widely used in clinical trials in concentrations ranging from 0.01% to 1.0%.
Atropine is at present the agent with the highest efficacy and optimal safety profile to reduce myopia progression in children and adolescents.
MODERATO study, a phase III, prospective, multicentric, randomized, double blind, multiple doses, placebo-controlled parallel-group, adaptive study, aims to evaluate the efficacy and safety of 0.025% and 0.05% atropine eye drops in children and adolescents aged 3 to under 18 years old over a 24-month period, to understand its ability to manage and stop myopia getting worse. It will be conducted in 11 centers in Italy, Spain, Poland, the UK and Albania.

Start Date01 Jul 2025

Sponsor / Collaborator

Ocus Innovation Ireland Ltd.

[+1]

ChiCTR2500101777

/ SuspendedPhase 4IIT

Research on the effect of low concentration atropine on the progression of myopia in children and its correlation with accommodative function

Start Date30 Apr 2025

Sponsor / Collaborator-

ChiCTR2500101180

/ RecruitingPhase 4IIT

Clinical Trial of Low-concentration Atropine Eye Drops in Preventing the Onset of Myopia in Children

Start Date21 Apr 2025

Sponsor / Collaborator-

100 Clinical Results associated with Atropine Sulfate

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100 Translational Medicine associated with Atropine Sulfate

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100 Patents (Medical) associated with Atropine Sulfate

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35,402

Literatures (Medical) associated with Atropine Sulfate

01 Sep 2025·VISION RESEARCH

Atropine restores retinal glutamate / γ-aminobutyric acid levels in vitro in an experimental chick model of myopia

Article

Author: Collins, Andrew V ; Phillips, John R ; Acosta, Monica L ; Lloyd, Jordan T

Atropine is widely used to slow childhood myopia progression, but its mechanisms of action remain poorly understood. This study investigated atropine's effects on retinal neurochemistry in a chick model of form-deprivation myopia (FDM). Myopia was induced in chicks via monocular FDM. Retinas from FDM and contralateral normal eyes were enucleated, bisected and six retinal samples per group were incubated for 60 min in vitro in either 1.8 mM atropine or normal physiological buffer. Samples were fixed in glutaraldehyde for neurotransmitter detection using silver-intensified immunogold labelling. In a separate experiment, the incubation procedure of FDM and normal eyes was repeated and tissues were fixed in formaldehyde to examine dopaminergic neurons using tyrosine hydroxylase (TH) immunofluorescence. No significant changes in TH immunolabelling were observed between groups. However, myopia reduced glutamate levels by 43% compared to controls, with altered glutamate distribution in the inner retina. Bipolar cells in myopic eyes also showed a 57% decrease in glutamine levels. Within 60 min, atropine treatment restored both glutamate and glutamine levels toward normal levels. The most noteworthy changes to gamma aminobutyric acid (GABA) was a 62% reduction observed in the outer plexiform layer (OPL) between normal and myopic retinas. Following atropine treatment, there was a further decrease in (GABA) levels in OPL and horizontal cells. These findings suggest that one immediate effect of atropine treatment is to restore the balance of neurotransmitters that are disrupted in myopia, elevating glutamate while reducing GABA. This neurotransmitter modulation may contribute to atropine's therapeutic effects in myopia control.

01 Aug 2025·MICROBIAL PATHOGENESIS

Antiviral activity and mechanisms of action of atropine, rutin, and hypoxanthine against tomato Brown rugose fruit virus

Article

Author: Salehzadeh, Mehrdad ; Afsharifar, Alireza ; Izadpanah, Keramatollah

Plant viral diseases cause considerable damage to the agricultural industry and are difficult to control. Recently, botanical biopesticides that are environmentally friendly, safe for non-target organisms, and not prone to developing drug resistance have shown great potential as antiviral agents. In the present study a screening of natural products with antiviral potential was conducted, and three compounds - atropine, rutin, and hypoxanthine - were identified to possess anti-tomato brown rugose fruit virus (ToBRFV) activity. Further, the modes of action of these compounds were investigated. The results of the bioassay revealed that atropine, rutin and hypoxanthine were effective at concentrations of 50, 100 and 150 μg mL^-1 in inactivating, inhibiting proliferation and protecting against ToBRFV when combined with atropine and rutin. As the concentration of compounds increased, their antiviral properties were found to be enhanced. These compounds were found to reduce the expression of the coat protein and the replicase genes of ToBRFV. Atropine and rutin, in particular, demonstrated substantial anti-ToBRFV effects with diverse modes of action when used alone or in combination. Hypoxanthine demonstrated a comparatively weaker antiviral effect than the other two compounds, and when combined with the latter, the antiviral activity of the other compounds was also reduced to a certain extent. These results provided key proof that these compounds may represent a promising source of novel antiviral agents for agricultural use.

01 Jul 2025·Ophthalmology science

Additive Effect of Highly Aspherical Lenslet Target Spectacles to Children Inadequately Controlled by Atropine Monotherapy

Article

Author: Sim, Bryan Xiangrong ; Balakrishnan, Maithily ; Sri, Yudah ; Lam, Crystal Shue Wen ; Chan Poh Lin, Pauline ; Loh, Kai Lyn ; Htoon, Hla Myint ; Chia, Audrey Wei Lin ; Sim, Ralene Zi Hui

Purpose:

Myopia progression in children, especially in East Asia, is a significant public health concern. This study evaluated the efficacy of combining myopia control spectacle lenses with Highly Aspherical Lenslet Target (HALT) technology and atropine in children who continued to progress on low-dose atropine (LDA).

Design:

Prospective cohort.

Subjects:

Children aged 6-11 years with ≥0.5 diopters (D) myopia progression over 6 months on LDA (0.01% or 0.025%) were recruited.

Methods:

All participants used HALT (Essilor Stellest) spectacle lenses while maintaining their LDA dose. The changes in spherical equivalent (SE) and axial length (AL) were tracked for 6 months before and 6-12 months after starting combination treatment.

Main Outcome Measures:

Progression of SE and AL.

Results:

Fifty children (mean age 8.9 ± 1.1 years) were separated into group A (on 0.01% atropine daily, n20) and group B (on 0.01% atropine twice daily, n5 and 0.025% atropine nightly, n25). Most (86%) were ethnic Chinese. The baseline SE and AL showed no significant intergroup differences, with prior myopia progression (0.60D/0.24 mm) over 6 months. After adding HALT lenses, progression slowed to -0.06D/0.06 mm at 6 months and -0.15D/0.14 mm at 12 months. A hyperopic shift in AL was seen in 11 children (24%). However, the progression of >0.5D was noted in 20%, with 18% and 40% progressing by >0.3 mm and >0.15 mm, respectively. Univariate analysis suggested that children who progressed >0.10 mm over 6 months were more likely to be younger, whereas multivariate analysis suggested that change in AL was associated with smaller pupil size (possibly from poor compliance or absorption of atropine) at 6 months and younger age at 12 months, after controlling for sex, race, and baseline SE and AL. There were no complaints of glare, near, or peripheral blur in children after starting combination treatment.

Conclusions:

The addition of HALT spectacle lenses significantly reduced myopia progression in children, aged 6-11 years, who were poorly controlled on LDA alone demonstrating a potential synergistic effect with LDA. These findings supported combination therapy for managing challenging myopia cases.

Financial Disclosures:

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

101

News (Medical) associated with Atropine Sulfate

12 Jun 2025

·www.businesswire.com

HOYA Vision Care Unveils Updates from the Association for Research in Vision and Ophthalmology (ARVO) 2025 Annual Meeting

SALT LAKE CITY--(BUSINESS WIRE)--HOYA Vision Care (https://www.hoyavision.com/) today announced new clinical evidence from three key clinical studies highlighting the impact of Defocus Incorporated Multiple Segments (D.I.M.S.) Technology. The results were presented as part of the company’s 2025 scientific program, Exploring New Frontiers in Myopia Management with MiYOSMART*, at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Annual Meeting in Salt Lake City, Utah, USA. The latest findings from the world’s longest-running clinical study on myopia management spectacle lenses showed that continuous DIMS spectacle lens wear demonstrated significantly reduced myopia progression (-1.00D ± 0.41D, p=0.017) and axial elongation (0.42 ± 0.18 mm, p=0.019) consistently for the full 8 years (n=11) of follow-up.1 This evidence demonstrates that wearing MiYOSMART* spectacle lenses continuously and for the long-term may improve myopia management outcomes. Dr. Natalia Vlasak, Global Head of Medical and Scientific Affairs at HOYA Vision Care said "This landmark study, featuring the longest follow-up to date for myopia management spectacle lenses, reveals that long-term MiYOSMART use continues to significantly slow myopia progression so that children can enjoy their lives to the fullest. These findings emphasize the life-changing value of long-term adherence, providing crucial information and guidance for Eye Care Professionals and parents committed to protecting children’s vision health for the future.” The first 12-month data readout from the ASPECT randomized controlled trial demonstrated that combining low-dose 0.025% atropine eye drops with DIMS spectacle lenses stopped myopia progression in around 40% of children.2 The mean change in axial length, a key factor in myopia progression, was significantly lower than in the atropine-only group (0.07 ± 0.16 mm vs 0.18 ± 0.16 mm; p<0.001). The researchers also explored vision-related quality of life (VR-QoL), indicating a trend towards improvement in general vision (p=0.049) and competence (p=0.031) in children using low-dose atropine and DIMS spectacle lens combination treatment.4 "Our findings suggest that combining MiYOSMART spectacle lenses with atropine can unlock even greater outcomes for children with myopia progression – marking a positive step towards more personalized, powerful treatment strategies in myopia management that suit the unique needs of each child." said Dr Natalia Vlasak, Global Head of Medical and Scientific Affairs at HOYA Vision Care. A first-of-its-kind pilot study evaluating DIMS spectacle lenses for pre-myopia management in 5- and 6-year-old children indicated that the DIMS technology may offer a protective effect against the development of myopia in this population. Over nine months, the average cycloplegic spherical equivalent refraction (SER) remained stable with a yearly change of +0.06D compared to -0.15D in a control group. While axial length increased slightly (22.48 mm to 22.64 mm, p<0.01), the choroidal thickness remained stable. These promising initial findings suggest MiYOSMART spectacle lenses may help to prevent myopia development and postpone the myopia onset in pre-myopic preschoolers, laying the groundwork for future research.3 “With myopia rising at an alarming rate worldwide, finding effective strategies to slow its progression have never been more urgent,” said Dr. Vlasak. “With these studies, we continue to provide Eye Care Professionals and parents with confidence through evidence for the benefits of MiYOSMART spectacle lenses, both as a monotherapy and in combination treatment. We are proud to deliver on our mission to protect the long-term vision and quality of life for every child through our evidence-backed myopia management innovations.” For the abstracts presented at ARVO 2025, please visit https://www.hoyavision.com/visionary-knowlegde/blogs-and-article/conference-arvo-2025/ Product Disclaimer: *MiYOSMART spectacle lenses have not been approved for myopia management in all countries, including the United States, and are not currently available for sale in all countries.

Clinical Result

06 Jun 2025

·firstwordpharma.com

EU greenlights Santen’s Ryjunea for paediatric myopia

The European Commission granted marketing authorisation for Santen Pharmaceutical’s low-dose atropine eye drop Ryjunea to slow paediatric myopia progression, marking the first and only approved therapy for this indication in the EU.Ryjunea — available as a 0.1 mg/mL ophthalmic solution for once-daily administration — is specifically indicated for children aged 3 to 14 years at treatment initiation, having myopia progression of ≥0.5 D per year and a severity of -0.5 D to -6.0 D.Santen secured rights to commercialise the atropine formulation, codenamed SYD-101, in the EU, Middle East and Africa under a licensing agreement with Sydnexis in 2021. “With this approval, ophthalmologists now have an evidence-based medication to help slow the progression of myopia”, said Peter Sallstig, chief medical officer at Santen. The EU clearance — which closely follows a positive opinion adopted by the European drug advisory panel in April — is supported by the pivotal Phase III STAR study, which showed that Ryjunea slowed annual myopia progression by 30% over two years compared with placebo in children aged 3 to 14 years.Sydnexis, which continues to hold US rights to the drug, successfully completed an FDA regulatory filing in March, with a decision expected later this year. “We are excited about our continued interactions with the [FDA] leading up to our October 23 PDUFA date," remarked Patrick Johnson, president of Sydnexis.Santen’s 0.025% variant of the product was earlier approved in Japan and launched in April under the name Ryjusea Mini to slow myopia progression.

Phase 3Clinical ResultDrug ApprovalLicense out/in

06 Jun 2025

·www.pharmaceutical-technology.com

EC authorises Sydnexis’ paediatric myopia treatment

The authorisation in the EU signifies a step forward in eye care for paediatric patients. Credit: chaponta/Shutterstock. The European Commission (EC) has granted marketing authorisation to Sydnexis for its low-dose atropine formulation SYD-101, designed to slow the progression of paediatric myopia [shortsightedness]. The decision positions the therapy as the first and only approved pharmaceutical treatment for myopia progression within the European Union (EU), signifying a step forward in eye care for paediatric patients. The authorisation is supported by the data from the company’s pivotal Phase III STAR trial assessing SYD-101 in slowing the advancement of paediatric myopia and its associated risks in paediatric patients aged three to 14 years at the start of treatment. Following a positive opinion received in April 2025 from the European Medicines Agency’s Committee for Medicinal Products for Human Use, Japan-based eye health company Santen obtained the rights to commercialise the therapy under the brand name Ryjunea in Europe and the Middle East and Africa region. Sydnexis CEO Perry Sternberg stated: “This marks a significant milestone for Sydnexis and, most importantly, for paediatric patients with progressive myopia, their families and physicians as the first and only approved pharmaceutical treatment option in Europe. “This approval is an endorsement of the potential benefit SYD-101 can provide to millions of patients globally and reinforces the critical importance of early intervention.” GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Myopia is a widespread eye condition affecting children, estimated to impact roughly one-third of young individuals globally. Founded in 2014, Sydnexis is a US-based company and has recently concluded the three-year primary endpoint of its Phase III trial of the low-dose atropine formulation. The trial is currently in its fourth year, focusing on randomised withdrawal for exploratory endpoints, with third-year outcomes expected to be released after the fourth year’s completion. Sydnexis is backed by investment from RA Capital, Visionary Ventures, Bluestem Capital and Longitude Capital. Pharmaceutical Technology Excellence Awards - Have you nominated? Nominations are now open for the prestigious Pharmaceutical Technology Excellence Awards - one of the industry's most recognised programmes celebrating innovation, leadership, and impact . This is your chance to showcase your achievements, highlight industry advancements , and gain global recognition . Don't miss the opportunity to be honoured among the best - submit your nomination today! Nominate Now

Phase 3Drug Approval

100 Deals associated with Atropine Sulfate

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External Link

KEGG	Wiki	ATC	Drug Bank
D02069	Atropine Sulfate	A03BA01 S01FA01	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Myopia	Australia	Aspen Pharmacare Australia Pty Ltd.	13 Sep 2021
Heart Arrest	United States	Accord Healthcare, Inc.	29 Sep 2020
Mushroom Poisoning	United States	Accord Healthcare, Inc.	29 Sep 2020
Bradycardia	United States	Fresenius Kabi USA LLC	26 Jan 2018
Amblyopia	United States	Rising Pharmaceuticals, Inc.	18 Jul 2014
Arrhythmias, Cardiac	China	Chengdu First Pharmaceutical Co. Ltd.	01 Jan 1981
Pain	China	Chengdu First Pharmaceutical Co. Ltd.	01 Jan 1981
Poisoning	China	Chengdu First Pharmaceutical Co. Ltd.	01 Jan 1981
Organophosphate Poisoning	United States	Meridian Medical Technologies LLC	15 May 1973
Ophthalmoplegia	Japan	Santen Pharmaceutical Co., Ltd.	31 Mar 1970
Cycloplegia	Japan	ROHTO NITTEN Co., Ltd.	20 Jul 1968
Mydriasis	Japan	ROHTO NITTEN Co., Ltd.	20 Jul 1968

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Myopia, Degenerative	Phase 3	United States	Ocumension Therapeutics	01 Apr 2021

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03911271 (APP \| 2018-001286-16 \| ###DELETE, CTgov)	Phase 2	Myopia	97	0.1% atropine and 0.01% atropine (Loading Dose)	jbbctcxqbe(tlgedbywfg) = gimytrmnry qgrsmqxoel (bvssomtehz, kxqquykdrt - vgpwyewxhc) View more	-	18 Jun 2025
				0.01% atropine (Low Dose)	jbbctcxqbe(tlgedbywfg) = cewqtjuemn qgrsmqxoel (bvssomtehz, cvqfuwbnmn - nfhykjkgvs) View more
NCT06366087 (SABER, CTgov)	Phase 1	-	46	Atropine Sulfate Ophthalmic Solution USP, 1% (Sublingual)	jxfcsgxztq(zmboazltmc) = qkcnzsikva hofuupcphg (iwgxfzgool, 23.0) View more	-	04 Apr 2025
				Atropine Sulfate Injection, USP 8 mg/20 mL (0.4 mg/mL) (Intramuscular)	jxfcsgxztq(zmboazltmc) = rhwjtarezd hofuupcphg (iwgxfzgool, 19.0) View more
NCT06209281 (Mini-CHAMP, NEWS) Manual	Phase 3	Myopia	526	NVK002	lpdbsujxuh(piusrzhsah) = 达到了其主要疗效终点。 bzeqbiwozc (kwqfthgufh ) Met View more	Positive	07 Jan 2025
				Placebo
NCT03750656 (HyTa Stent, CTgov)	Phase 4	Lower Urinary Tract Symptoms	5	Hyoscyamine (Hyoscyamine)	jwropklqww(aeporctwrz) = iijulisony zuwzbwokfq (nrdlyshrrz, vhzxmbrepn - aqhfadhwaf) View more	-	03 Dec 2024
				Tamsulosin (Tamsulosin)	jwropklqww(aeporctwrz) = xacznjulvs zuwzbwokfq (nrdlyshrrz, hthsbuyupd - mutgmtowll) View more
NCT03350620 (CHAMP, CTgov)	Phase 3	Myopia	670	NVK-002 Concentration 1 (NVK-002 Concentration 1)	szljhwalon = bpozxjwjkc obhijbmhlf (pqyrirxvhb, kjlcgkesvo - rgtduhlnts) View more	-	27 Nov 2024
				NVK-002 Concentration 2 (NVK-002 Concentration 2)	szljhwalon = uzhqccuirm obhijbmhlf (pqyrirxvhb, kdfyfjozvi - uemifdnlpt) View more
NCT03942419 (CHAPERONE, GlobeNewswire) Manual	Phase 3	Myopia	252	0.01% atropine ophthalmic metered spray	wrexkkranx(uvqivhscqw) = not significantly different bwrjwgjgff (dzwfvhipoe ) View more	Negative	15 Nov 2024
				0.1% atropine ophthalmic metered spray
NCT06209320 (China CHAMP, Corporate Publications \| NEWS) Manual	Phase 3	Myopia	-	NVK002	espwrrcplx(uhmkbhdzok) = NVK002滴眼液组（0.01%和0.02%剂量）对比安慰剂组在主要疗效指标上有统计学意义的显著性差异，NVK002滴眼液组优于安慰剂组，且具有剂量依赖。 xivjycnqzy (nrdbdcwbxb ) View more	Positive	24 Oct 2024
				Placebo
NCT03374306 (CTgov)	Not Applicable	Myopia	71	Atropine (0.01%) (Atropine 0.01%)	uvlysahcna(kbothsnadz) = tfqjhbabox mhvazbpevy (ghfbvrykhv, 0.39) View more	-	16 Oct 2024
				Artificial tear (Artifical Tear)	uvlysahcna(kbothsnadz) = jtuadhwhgd mhvazbpevy (ghfbvrykhv, 0.41) View more
EURETINA2024 Manual	Not Applicable	Myopia	97	0.01% Atropine Eye Drops	velmadaeqf(tqibcapxze) = hfsniduuvc veyqtgfgnd (aczskgmvnc, 0.01 - 0.19) View more	Positive	19 Sep 2024
				0.1% LAtropineose Atropine Eye Drops	velmadaeqf(tqibcapxze) = fuauuwcjem veyqtgfgnd (aczskgmvnc, -0.01 to 0.17) View more
NCT03699423 (Pubmed \| J Ocul Pharmacol Ther) Manual	Phase 1	Myopia	57	0.01% atropine eye drops	fzmlybhcfk(xhatkkkiyp) = dydzivceox mlwhafyxqn (ttslkznscl ) View more	Positive	15 Apr 2024
				0.02% atropine eye drops	fzmlybhcfk(xhatkkkiyp) = wccfxkuasq mlwhafyxqn (ttslkznscl ) View more