The purpose of this study is to assess the target occupancy (TO) of scopolamine at M1 Muscarinic Receptors in the brain after single I.V. doses of scopolamine, in healthy control subjects, using the radiotracer [11C]EMO (also known as [11C]LSN3172176).

Start Date01 Mar 2025

Sponsor / Collaborator

Yale University

[+1]

ChiCTR2500097562

/ SuspendedPhase 4IIT

Prognostic impact of scopolamine hydrobromide injection in patients with hyperlactate septic shock: a prospective, multicentre, randomised, double-blind, placebo-parallel controlled clinical study

Start Date22 Feb 2025

Sponsor / Collaborator

Ruijin Hospital

PACTR202407805328722

/ SuspendedPhase 4IIT

Effect of hyoscine N-Butyl bromide on progress of labour and pregnancy outcome; A randomized control trial

Start Date01 Oct 2023

Sponsor / Collaborator-

100 Clinical Results associated with Scopolamine Hydrobromide Hydrate

100 Translational Medicine associated with Scopolamine Hydrobromide Hydrate

100 Patents (Medical) associated with Scopolamine Hydrobromide Hydrate

1,208

Literatures (Medical) associated with Scopolamine Hydrobromide Hydrate

01 Mar 2025·ChemistryOpen

Synergistic Antiemetic Effects of Nerolidol on Domperidone, Hyoscine, and Ondansetron: In Vivo and in Silico Investigations on Receptor Binding Affinity

Article

Author: Torequl Islam, Muhammad ; Bhuia, Md. Shimul ; Ghosh Situ, Sharmita ; Al Hasan, Sakib ; Akber Ansari, Siddique ; Chowdhury, Raihan ; Aamer Ansari, Irfan ; Ali, Arman

AbstractThe present study was designed to measure the potential antiemetic properties of nerolidol (NDL) via in vivo and in silico studies. To induce emesis copper sulfate pentahydrate (CuSO4.5H2O) was administered at a dose of 50 mg/kg (orally) to 2‐day‐old chicks. The test sample (NDL) was given at two doses of 50 and 100 mg/kg. b.w. orally. Additionally, aprepitant (16 mg/kg), domperidone (6 mg/kg), hyoscine (21 mg/kg), ondansetron (5 mg/kg), and diphenhydramine (10 mg/kg) were given also orally as positive controls. To observe the modulatory effects of the test sample, combination therapies with reference drugs were also administered to three different groups of animals. Molecular docking and visualization of ligand‐receptor interaction were performed against several emesis‐inducing receptors (5HT3, D2, D3, H1, and M1‐M5) using diverse computational tools. Pharmacokinetics and drug‐likeness of the selected ligands were also calculated. Findings demonstrated that NDL significantly (p <0.05) dose‐dependently lessens the mean number of retches and delays the emetic onset in the chicks. The combined drug therapy with ondansetron exposed better antiemetic activity. In addition, in silico analysis, NDL has greater binding affinity (−7.3 kcal/mol) against M2 and M3 receptors. In conclusion, NDL exerted mild antiemetic activity with synergistic properties through muscarinic receptors.

01 Jan 2025·Gut

Combined MRI, high-resolution manometry and a randomised trial of bisacodyl versus hyoscine show the significance of an enlarged colon in constipation: the RECLAIM study

Article

Author: Gowland, Penny ; Knowles, Charles H ; Dinning, Philip ; Taylor, Stuart A ; Wilkinson-Smith, Victoria ; Wiklendt, Lukasz ; Marciani, Luca ; Hoad, Caroline Louise ; Scott, Mark ; Corsetti, Maura ; Spiller, Robin C ; Sansone, Stefano ; Atkinson, David ; Zdanaviciene, Ausra ; Coupland, Carol ; Menys, Alex

BackgroundColonic motility in constipation can be assessed non-invasively using MRI.ObjectiveTo compare MRI with high-resolution colonic manometry (HRCM) for predicting treatment response.DesignPart 1: 44 healthy volunteers (HVs), 43 patients with irritable bowel syndrome with constipation (IBS-C) and 37 with functional constipation (FC) completed stool diaries and questionnaires and underwent oral macrogol (500–1000 mL) challenge. Whole gut transit time (WGTT), segmental colonic volumes (CV), MRI-derived Motility Index and chyme movement by ‘tagging’ were assessed using MRI and time to defecation after macrogol recorded. Left colonic HRCM was recorded before and after a 700 kcal meal. Patients then proceeded to Part 2: a randomised cross-over study of 10-days bisacodyl 10 mg daily versus hyoscine 20 mg three times per day, assessing daily pain and constipation.ResultsPart 1: Total CVs median (range) were significantly greater in IBS-C (776 (595–1033)) and FC (802 (633–951)) vs HV (645 (467–780)), p<0.001. Patients also had longer WGTT and delayed evacuation after macrogol. IBS-C patients showed significantly reduced tagging index and less propagated pressure wave (PPW) activity during HRCM versus HV. Compared with FC, IBS-C patients were more anxious and reported more pain. Abnormally large colons predicted significantly delayed evacuation after macrogol challenge (p<0.02), impaired manometric meal response and reduced pain with bisacodyl (p<0.05).Part 2: Bisacodyl compared with hyoscine increased bowel movements but caused more pain in both groups (p<0.03).ConclusionAn abnormally large colon is an important feature in constipation which predicts impaired manometric response to feeding and treatment responses. HRCM shows that IBS-C patients have reduced PPW activity.Trial registration numberThe study was preregistered on ClinicalTrials.gov, Reference:NCT03226145.

17 Nov 2024·Cureus

Esophagogastroduodenoscopy Quality Improvement and the Role of Topical Antiperistaltic Agents: A Systematic Review and Meta-Analysis

Review

Author: Burke, Eoghan ; Harkins, Patricia ; Arumugasamy, Mayilone

Gastric cancer (GC) represents one of the most lethal forms of cancer. When identified at an early stage, conventional treatment can be curative. The key to identifying GC at an early stage is high-quality esophagogastroduodenoscopy (EGD). This has led to an increased focus on quality standards in EGD to improve the detection rates of early GC and its premalignant lesions (PMLs), such as atrophic gastritis. In Asia, the routine use of antiperistaltic (antispasmodic) agents is advocated to improve the quality of mucosal visualization during diagnostic EGD. The rationale is that the cessation of peristalsis should yield a more stable intragastric visual field to enhance the detection of early GC. Hyoscine and glucagon are commonly used as antiperistaltic agents. Both, however, must be given either intravenously or via intramuscular injection. They both also have potentially serious systemic side effects, which can limit their routine use, particularly in the elderly or co-morbid patients. As a result of these side effects, there is growing interest in using peppermint oil or L-menthol topically as anti-peristaltic agents. As these agents are applied topically (either via direct spraying during the EGD or consumed as a premedication before the EGD), they are associated with fewer adverse events than systemically applied agents. This study aimed to synthesize, for the first time, the available data on the use of topically applied anti-peristaltic agents to decrease or stop peristalsis during diagnostic EGDs. This study is a systematic review and meta-analysis of published randomized controlled trials. Its reporting is per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. This study was registered prospectively with the PROSPERO register, registration number CRD42024601488. This systematic review and meta-analysis encompassed five high-quality randomized controlled trials with a low risk of bias. All included studies were conducted in Asian countries between 2011 and 2022. They comprised 538 patients, with a mean age of 62.7. Four of the included studies look at topically applied L-menthol at 160 mg, while one study looked at the role of 160 mg of phloroglucinol administered as a 20 mL oral premedication liquid 15 minutes before the EGD. All included trials involved diagnostic EGDs and reported their primary outcomes using the same scoring systems. The primary outcome of interest for this study was the efficacy of the antiperistaltic agents at stopping peristalsis for the duration of a diagnostic EGD. We found an odds ratio of 4.22 with a 95% confidence interval ranging from 2.47 to 7.21, favoring the antiperistaltic agents in terms of attaining a peristalsis score of 1 after administration. This systematic review and meta-analysis represent the most up-to-date review on topical antiperistaltic agents during diagnostic EGD. We found that topical antiperistaltic agents effectively decrease or stop peristalsis during an EGD, and these effects persist for the duration of the EGD. Larger-scale studies will be required to determine whether their routine use translates into increased detection rates of early GC and its PMLs.

News (Medical) associated with Scopolamine Hydrobromide Hydrate

08 Jan 2025

·www.echemi.com

80 batches of drugs recalled urgently! A major decision by the National Medical Products Administration

Recently, the National Medical Products Administration announced an important decision to stop the production, sale, and use of Hyoscine Butylbromide Tablets, and to revoke its drug registration certificate. According to the announcement issued by the National Medical Products Administration on January 3, titled “Announcement on the Revocation of the Drug Registration Certificate for Hyoscine Butylbromide Tablets (2025 No. 2)”, Hyoscine Butylbromide Tablets, an antibacterial drug also known as Loperamide, will no longer circulate in the market of our country. This decision is effective immediately, and the products already on the market will be recalled by the marketing authorization holder and supervised by provincial drug regulatory authorities for destruction or other harmless disposal measures. A total of 80 batches of Hyoscine Butylbromide Tablets are involved. In addition, in another announcement issued by the National Medical Products Administration on December 2, 2024, it was also announced that 58 drug registration certificates, including 11 batches of Hyoscine Butylbromide Tablets, have been revoked. Based on Article 83 of the Drug Administration Law of the People's Republic of China and other relevant regulations, these drugs have been required to stop production and sale due to unclear efficacy, serious adverse reactions, or other hazards to human health. Hyoscine Butylbromide Tablets are a compound preparation, with the main active ingredients including Hyoscine Tincture, Sulfamethoxazole, and Trimethoprim, primarily used to treat dysentery caused by Shigella and other sensitive pathogenic bacteria causing enteritis. However, with the withdrawal of this drug from the market, other drugs such as Montmorillonite Powder will take on the responsibility for treating diarrhea. According to data from Miiine, the incidence of gastrointestinal diseases is on the rise and is becoming more prevalent among younger populations. In the first three quarters of 2022, the sales of anti-diarrheal drugs and intestinal anti-inflammatory/infection drugs in public hospitals in key provinces and cities in China exceeded 1.2 billion yuan, a year-on-year increase of 6.30%. The sales scale of Montmorillonite Powder in the three major terminal markets in China has exceeded 1 billion yuan, with the outpatient market being the main sales channel, rising by 60%, making it the Top 2 product in anti-diarrheal and intestinal anti-inflammatory/infection drugs. Statistics from Cyborg Blue show that 145 drug registration certificates were revoked in 2024. In the announcement on December 2, 2024, in addition to Hyoscine Butylbromide Tablets, it also included 3 batches of Losartan Potassium Tablets, 2 batches of Phenazone Tablets, 2 batches of Amlodipine Besylate Tablets, 2 batches of Entecavir Tablets, 2 batches of Compound Snake Gall and Chuan Bei Powder, and 2 batches of Rifampicin Capsules. Phenazone, as a pyrazolone analgesic and antipyretic, was launched early in our country, but its injection and nasal drops have severe adverse reactions, with risks outweighing benefits, and alternative medications are available, leading to its registration certificate being revoked in 2020. Although oral preparations like Phenazone Tablets still have certain clinical value, the National Medical Products Administration has implemented risk control measures by revising the instructions to add safety warnings, restricting applicable populations and indications. In the domestic market for antipyretic and analgesic drugs, Phenazone has a low market share and is declining. Data from Cyborg Blue shows that there are 861 approvals for "Phenazone Tablets," involving many companies and intense market competition. As related drug approvals are revoked, this market will face further fragmentation. Finally, according to the relevant provisions of the Regulations on the Implementation of the Drug Administration Law of the People's Republic of China and the Drug Registration Management Measures, the National Medical Products Administration decided on April 11, 2024, to revoke the registration certificates for 87 drugs, including Pancreatin Injection. Cyborg Blue’s analysis found that drugs such as 7 batches of Iohexol Injection, 6 batches of Insulin Glargine Injection, 4 batches of Detemir Insulin Injection, 4 batches of Vardenafil Hydrochloride Tablets, and 3 batches of Brain Protein Hydrolysate Injection were also revoked. Please note that the number of drugs counted in the text has not been deduplicated. No. Marketing Authorization Holder Approval Number 1 Shijiazhuang Lesheng Pharmaceutical Co., Ltd. SFDA H13023949 2 Jiangzhong Pharmaceutical Co., Ltd. SFDA H36022316 3 Shijiazhuang Fourth Pharmaceutical Co., Ltd. SFDA H13023932 4 Shijiazhuang Grey Pharmaceutical Co., Ltd. SFDA H13023934 5 Handan Bailin Pharmaceutical Co., Ltd. SFDA H13023945 6 Hebei Yongfeng Pharmaceutical Co., Ltd. SFDA H13023943 7 China National Pharmaceutical Group Wuhan Zhonglian Fourth Pharmaceutical Co., Ltd. SFDA H42022497 8 Jiangsu Enhua Pharmaceutical Co., Ltd. SFDA H32025932 9 Jiangxi Hongshuo Pharmaceutical Co., Ltd. SFDA H36022013 10 Jiangxi Hongshuo Pharmaceutical Co., Ltd. SFDA H36022244 11 Jiangsu Chenpai Pharmaceutical Group Co., Ltd. SFDA H32025935 12 North China Pharmaceutical Hebei Huanuo Co., Ltd. SFDA H13024102 13 North China Pharmaceutical Hebei Huanuo Co., Ltd. SFDA H13024073 14 Hebei Hengli Group Pharmaceutical Co., Ltd. SFDA H13024253 15 Hebei Tianzhi Pharmaceutical Co., Ltd. SFDA H13024245 16 Hebei Dongfeng Pharmaceutical Co., Ltd. SFDA H13024170 17 Hebei Jinzhuan Pharmaceutical Co., Ltd. SFDA H13024269 18 Tianjin Baihai Pharmaceutical Co., Ltd. SFDA H12021099 19 Henan Daxin Pharmaceutical Co., Ltd. SFDA H41024876 20 Henan Daxin Pharmaceutical Co., Ltd. SFDA H41025013 21 Shanxi Xinxing Pharmaceutical Co., Ltd. SFDA H14023068 22 Jiangxi Jiminke Pharmaceutical Co., Ltd. SFDA H36022305 23 Suzhou Hongsun Pharmaceutical Co., Ltd. SFDA H32025897 24 Jiangsu Puhua Kesheng Pharmaceutical Co., Ltd. SFDA H32026256 25 Guangxi Tiantianle Pharmaceutical Co., Ltd. SFDA H45021319 26 Tianjin Central Pharmaceutical Co., Ltd. SFDA H12021120 27 Tianjin Central Pharmaceutical Co., Ltd. SFDA H12021117 28 Shanghai Modern Harsen (Shangqiu) Pharmaceutical Co., Ltd. SFDA H41024989 29 Tianjin Pacific Pharmaceutical Co., Ltd. SFDA H12021100 30 Hebei Guojin Pharmaceutical Co., Ltd. SFDA H13023940 31 Hebei Kaiwei Pharmaceutical Co., Ltd. SFDA H13023920 32 Hebei Sanshi Pharmaceutical Co., Ltd. SFDA H13023928 33 Yuanda Pharmaceutical (China) Co., Ltd. SFDA H42022649 34 Shanxi Tongda Pharmaceutical Co., Ltd. SFDA H14023309 35 Shanxi Guorun Pharmaceutical Co., Ltd. SFDA H14023402 36 Shanxi Fenhe Pharmaceutical Co., Ltd. SFDA H14023200 37 Shanxi Wanhui Pharmaceutical Co., Ltd. SFDA H14023333 38 Jilin Wantong Pharmaceutical Co., Ltd. SFDA H22025288 39 Changchun Overseas Pharmaceutical Group Co., Ltd. SFDA H22026726 40 Shijiazhuang Xiehe Pharmaceutical Co., Ltd. SFDA H13024084 41 Shandong Xinyi Pharmaceutical Co., Ltd. SFDA H37023541 42 Kuihua Pharmaceutical Group (Hengshui) Defier Co., Ltd. SFDA H13023979 43 Shijiazhuang Kanghewai Pharmaceutical Co., Ltd. SFDA H13024261 44 Shandong Xinhua Pharmaceutical Co., Ltd. SFDA H37023523 45 Hebei Yuzhilin Pharmaceutical Co., Ltd. SFDA H13024426 46 Xinhai Yansheng Pharmaceutical Co., Ltd. SFDA H41024907 47 Fu'an Pharmaceutical Group Yantai Zhichu Pharmaceutical Co., Ltd. SFDA H37023543 48 Dingfukang Pharmaceutical Co., Ltd. SFDA H41025139 49 Dingfukang Pharmaceutical Co., Ltd. SFDA H41025174 50 Changchun Changqing Pharmaceutical Group Co., Ltd. SFDA H22025234 51 Henan Baiquan Pharmaceutical Co., Ltd. SFDA H41024840 52 Changzhou Kangpu Pharmaceutical Co., Ltd. SFDA H32025910 53 Henan Baiquan Pharmaceutical Co., Ltd. SFDA H41025575 54 Lepu Hengjiuyuan Pharmaceutical Co., Ltd. SFDA H41024862 55 Hebei Ruicen Pharmaceutical Co., Ltd. SFDA H13023953 56 Hainan Xiansheng Pharmaceutical Co., Ltd. SFDA H46020588 57 Hainan Xiansheng Pharmaceutical Co., Ltd. SFDA H46020604 58 Yaodu Pharmaceutical Group Co., Ltd. SFDA H13023951 59 Shandong Xinyi Pharmaceutical Co., Ltd. SFDA H37023939 60 Shijiazhuang Pharmaceutical Group Ouyi Pharmaceutical Co., Ltd. SFDA H13023952 61 Tianfang Pharmaceutical Co., Ltd. SFDA H41024887 62 Lepu Hengjiuyuan Pharmaceutical Co., Ltd. SFDA H41025576 63 Zhejiang Huisong Pharmaceutical Co., Ltd. SFDA H33022412 64 Zhejiang Huisong Pharmaceutical Co., Ltd. SFDA H33022411 65 Shanghai Kaibao Xinyi (Xinxiang) Pharmaceutical Co., Ltd. SFDA H41024834 66 Henan Xueyinghua Pharmaceutical Co., Ltd. SFDA H41024896 67 Henan Xueyinghua Pharmaceutical Co., Ltd. SFDA H41025009 68 Shijiazhuang Pharmaceutical Group Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. SFDA H13023994 69 Handan Furong Pharmaceutical Co., Ltd. SFDA H13024077 70 Hebei Tiancheng Pharmaceutical Co., Ltd. SFDA H13024056 71 Hebei Kangtai Pharmaceutical Co., Ltd. SFDA H13024041 72 Guangdong Bidi Pharmaceutical Co., Ltd. SFDA H44025328 73 Guangdong Bidi Pharmaceutical Co., Ltd. SFDA H44024963 74 Zhengzhou Furuitang Pharmaceutical Co., Ltd. SFDA H41025579 75 Chongqing Kerui Pharmaceutical (Group) Co., Ltd. SFDA H50021730 76 Baiyun Mountain Dongtai Shangqiu Pharmaceutical Co., Ltd. SFDA H41024872 77 Xinxiang Changle Pharmaceutical Co., Ltd. SFDA H41024895 78 Xinxiang Changle Pharmaceutical Co., Ltd. SFDA H41025012 79 Baiyun Mountain Dongtai Shangqiu Pharmaceutical Co., Ltd. SFDA H41025008 80 Tianfang Pharmaceutical Co., Ltd. SFDA H41025010

Drug ApprovalNDA

14 Jun 2024

·www.biospace.com

EU Says India’s Alchem Is Part of International Drug Price-Fixing Cartel

Pictured: The Berlaymont building in Belgium, which houses the European Commission iStock, olrat The European Commission has tagged India-based pharma Alchem as being part of a global cartel that coordinates the pricing of a pharmaceutical ingredient in the antispasmodic drug Buscopan. The European Commission on Thursday accused India-based pharma company Alchem International of taking part in a “long-lasting cartel” to fix the minimum price of a widely used pharmaceutical ingredient. The EC is alleging that Alchem has worked with other market players to fix prices and establish minimum quotas for N-Butylbromide Scopolamine/Hyoscine, more popularly known as SNBB, a component of the antispasmodic drug Buscopan and its generic versions. Margrethe Vestager, executive vice president in charge of competition policy at the EC, in a statement said that Alchem could have engaged in an “agreement with competitors to coordinate prices and allocate quotas” for SNBB. These actions may have harmed European consumers and resulted in “restricted access to affordable medicines.” The watchdog has already informed Alchem of its allegations and investigation. The pharma company can then review the EC’s documents and request an oral hearing to present its response. After Alchem’s defense, if the EC still finds the company in violation of anti-trust regulations, then the watchdog can adopt a ruling that prohibits such corporate conduct and fine Alchem for up to 10% of its annual worldwide turnover. Thursday’s investigation into Alchem follows a previous SNBB probe by the EC. In October 2023, the watchdog found that several other pharma companies also participated in this price-fixing cartel, including Alkaloids of Australia, Alkaloids Corporation, Transo-Pharm, Linnea and Boehringer. The companies were hit with a total fine of approximately $14.35 million. A sixth company, C2 PHARMA, also took part in the cartel but was exempted from the fine because it qualified for the EC’s leniency program by revealing the cartel to investigators. The October 2023 fine represented the first time the EC sanctioned a cartel in the pharmaceutical sector. The EC in recent months has stepped up its crackdown on anti-competitive practices in the pharma industry. In April 2024, the watchdog announced that its investigation into CSL Vifor, formerly Vifor Pharma, has culminated in the company agreeing to a comprehensive, multi-channel communication effort to undo the effects of a multi-year misinformation campaign against a competitor drug. In July 2023, the EC slapped DNA sequencing giant Illumina with a $476 million fine —the largest penalty that the agency has ever meted out under its merger regulations. The fine is for Illumina’s 2020 acquisition of cancer detection biotech Grail, which it pushed through prior to the EC completing its anti-trust review of the deal. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com .

Acquisition

31 Jan 2024

·www.pharmaceutical-technology.com

Defender’s plans for motion sickness nasal gel stop with FDA rejection

Nasa is helping with Defender’s development of DPI-386, as astronauts are particularly susceptible to motion sickness in space. Image credit: Shutterstock/Supamotionstock.com. The FDA has decided to not approve Defender Pharmaceuticals’ intranasal scopolamine candidate for motion sickness, issuing a complete response letter (CRL) to the US-based company. Defender’s drug, known as DPI-386, is indicated for the prevention of nausea and vomiting induced by motion in adults. Defender’s CEO Barry I Feinberg said the company plans on scheduling a formal meeting with the FDA to discuss the issues raised and to create a plan going forward, in a 30 January press release. DPI-386 is a nasal gel version of the antimuscarinic drug scopolamine, first approved by the FDA as a transdermal patch in 1979, according to the drug’s label . Currently, patches are placed behind the ear and work with high efficacy by depressing the parasympathetic nervous system. The gel could be particularly useful for astronauts and military personnel who are frequently exposed to motion. Nasa joined forces with Epiomed Therapeutics to develop a fast-acting nasal spray version of scopolamine in 2012. According to the St Louis Post-Dispatch , Defender purchased Epiomed in 2014 and was founded the same year. Headquartered in St Louis, Missouri, the company has also worked with the United States Naval Medical Research Unit. See Also: Tyra Biosciences’ TYRA-300 gains FDA rare paediatric disease status Revolo advances plans to tackle eosinophilic esophagitis with orphan drug tag Defender’s formulation aims for rapid absorption to induce quicker onset. In a Phase III trial more than 500 participants, who usually get motion sick, had improved symptoms after being exposed to open sea conditions while using DPI-386. Subjects who received the nasal gel demonstrated lower incidences of vomiting and fewer requests for rescue medication compared to a placebo group. The incidence of moderate to severe nausea was also lower. In a September 2023 statement announcing the new drug application (NDA) acceptance, Defender said results from five phase III trials were submitted as evidence. The NDA was assigned priority review status by the FDA at the request of the US Navy. Feinberg added: “We remain confident that our intranasal scopolamine is a safe and effective therapy for the prevention of motion sickness, and we will work closely with the FDA to ensure that we can bring this innovative new product to the market.” Defender is also exploring the use of DPI-386 in major depressive disorder (MDD) with suicide ideation, chemical exposure accidents, and virtual reality sickness. In October 2023, Defender announced further collaborations with Nasa to study DPI-386 in Phase II trials to mitigate G-transition-induced motion sickness and enhance sensorimotor performance. Scopolamine recently made the news beyond the healthcare sector after rising incidences of it being linked to criminal activity. In June 2023, the US Embassy in Colombia highlighted the sedative side effects of the drug are being increasingly used to target tourists in the country. In certain doses, the drug can cause unconsciousness for 24 hours or more. Scopolamine was also the first drug to infamously garner the “truth serum” tag.

Phase 3Phase 2NDAClinical ResultDrug Approval

100 Deals associated with Scopolamine Hydrobromide Hydrate

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	S01FA02 N05CM05 A04AD01	DB00747

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Bipolar Disorder	China	Chengdu First Pharmaceutical Co. Ltd.	01 Jan 1981
Hyperemesis Gravidarum	China	Chengdu First Pharmaceutical Co. Ltd.	01 Jan 1981
Motion Sickness	China	Chengdu First Pharmaceutical Co. Ltd.	01 Jan 1981
Poisoning	China	Chengdu First Pharmaceutical Co. Ltd.	01 Jan 1981
Shock, Septic	China	Chengdu First Pharmaceutical Co. Ltd.	01 Jan 1981
Spasm	China	Chengdu First Pharmaceutical Co. Ltd.	01 Jan 1981
Anesthesia	Japan	KYORIN Pharmaceutical Co., Ltd.	01 Dec 1961
Parkinson Disease, Postencephalitic	Japan	KYORIN Pharmaceutical Co., Ltd.	01 Dec 1961

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Nausea	Phase 3	United States	Defender Pharmaceuticals, Inc.	30 Jan 2024
Vomiting	Phase 3	United States	Defender Pharmaceuticals, Inc.	30 Jan 2024
Motion Sickness	Phase 3	United States	Repurposed Therapeutics, Inc.	22 Apr 2019
Depressive Disorder, Major	Phase 3	United States	Repurposed Therapeutics, Inc.	01 Aug 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03435003 (CTgov)	Phase 4	Postoperative Nausea and Vomiting \| Vomiting	83	dexmedetomidine+Compazine+Total intravenous anesthesia+scopolamine transdermal+sugammadex+Reglan+Propofol+Fentanyl+Ondansetron+Aprepitant 80 mg Oral Capsule+Dexamethasone (Intervention Arm)	vuvsservmj(ieclffcocy) = eiyovnucry lizhtoasie (jtbkrjjvyz, cuyrutoqgd - rmveazehqe) View more	-	14 Feb 2024
				Compazine+sugammadex+Reglan+Sevoflurane+Desflurane+Ondansetron+Dexamethasone (Control Arm)	vuvsservmj(ieclffcocy) = xhfogzfdyw lizhtoasie (jtbkrjjvyz, upvngzmolp - irticbepgo) View more
NCT05548270 (DPI-386-MS-33, Corporate Publications) Manual	Phase 3	Motion Sickness	503	DPI-386	(tmlaiqnifk) = Findings showed the proportion of patients that met the primary endpoint was significantly greater in the intranasal scopolamine arm compared with the placebo arm (P <.0001). Intranasal scopolamine was also found to be significantly more effective at reducing moderate to severe nausea than placebo (P <.0001). gcqouffmte (qlvxbpllaz ) View more	Positive	06 Jun 2023
				Placebo
NCT02960113 (CTgov)	Phase 4	Nausea \| Vomiting	240	scopolamine patch (Scopolamine Patch)	kxygargnch(rvypitgmdl) = vfoqwornwl ibqnxbyksf (fwnikbvjkx, rxsfhphdze - kqkqjspdyu) View more	-	28 Dec 2022
				acupressure point P6 (Acupressure Point P6)	kxygargnch(rvypitgmdl) = pimenleiil ibqnxbyksf (fwnikbvjkx, avqueywvlm - ylhplbmcun) View more
NCT02849639 (INCREASE, CTgov)	Early Phase 1	Alzheimer Disease	90	Placebo+Scopolamine patch (Placebo)	ixxkuvisor(haaubazark) = ghfhaykcly ehesluleja (qyjcikugeg, qxrgqveoec - kyvrerxdfo) View more	-	22 Aug 2022
				Medication Therapy Management (MTM)+Scopolamine patch (Medication Therapy Management (MTM))	ixxkuvisor(haaubazark) = aszgpxjvyx ehesluleja (qyjcikugeg, yqbzrqeytr - aixfkkmmnr) View more
NCT03029650 (CTgov)	Phase 4	-	26	Intravenous scopolamine hydrobromide+Transderm Scop® (Transderm Scop®)	rxerhuorep(qchvwdfzyv) = otczfydpnz ajeahcvgzh (tpzwphgqbu, zsodcbapku - usxebskwmj) View more	-	21 Jun 2018
				Intravenous scopolamine hydrobromide+Transderm Scop® (Intravenous Scopolamine Hydrobromide)	rxerhuorep(qchvwdfzyv) = aeronwponz ajeahcvgzh (tpzwphgqbu, stizutueac - lenwogjbkr) View more
NCT01312844 (CTgov)	Phase 2	Depressive Disorder	7	Scopolamine (Scopolamine)	jkuofxlved(ifdtlidldm) = cuyzvahlma wcrcrizzns (rjipysjioh, aqpjlzbfco - lmfcuzzxla) View more	-	18 Apr 2017
				Scopolamine (Placebo)	jkuofxlved(ifdtlidldm) = wjetmoeuao wcrcrizzns (rjipysjioh, olkviurxna - iezjkfltdg) View more
NCT00369915 (CTgov)	Phase 2	Bipolar Disorder \| Depressive Disorder	17	Scopolamine (Plac/Scop)	gpynlghevd(bmhbareceo) = uqdyllntel lazedclnra (eggttuksss, yaewjbyvvo - enihkstkth) View more	-	29 Apr 2016
				Scopolamine (Scop/Plac)	gpynlghevd(bmhbareceo) = rzchmkymge lazedclnra (eggttuksss, jrqulsrfku - yswbeisnid) View more
NCT00659737 (CTgov)	Not Applicable	Nausea \| Postoperative Nausea and Vomiting \| Vomiting	115	Scopolamine	mciricwfvm(ohwsjzisop) = ppxhlheloy weemfttzsm (rsppjxsppl, mjazcxwaou - nddkrfxyda) View more	-	29 Apr 2014
NCT00717054 (CTgov)	Not Applicable	Nausea \| Postoperative Nausea and Vomiting \| Vomiting	115	Scopolamine+aprepitant (Aprepitant and Scopolamine Group)	fsaasvgxcz(jhtbxzhzgp) = coeshseziz xulpcarosr (mxcfxkbuwu, qenlqfmaqc - jxgpolbdzi) View more	-	29 Apr 2014
				Scopolamine (Aprepitant and Scopolamine Placebo Group)	ydvsseekwy(hdlrtcbuyp) = eufsqfoody bpbfhwoeth (bovedmbktz, hvbexmymwk - bqgqmmfpzv) View more

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Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Scopolamine Hydrobromide Hydrate

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation