Delving into the Latest Updates on Ropivacaine Mesylate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms-

Target

SCNA

Mechanism

SCNA modulators(Sodium channel alpha subunit modulators)

Therapeutic Areas

Other Diseases

Active Indication

Anesthesia

Inactive Indication-

Originator Organization-

Active Organization-

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date-

Regulation-

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Structure

Molecular FormulaC18H30N2O4S

InChIKeyYPTSIOMXZOPKAF-RSAXXLAASA-N

CAS Registry854056-07-8

The purpose of this study is to compare the effects of three different doses of hydromorphone combined with ropivacaine and sufentanil combined with ropivacaine in epidural labor analgesia through prospective clinical trials, so as to explore whether hydromorphone combined with ropivacaine has advantages in epidural labor analgesia, and find out the optimal dose of hydromorphone.
Participants will be randomly allocated to four groups : Group 1, Group 2, Group 3 and Group 4. For those in Group 1 : they will be administered with 15 ug/ml hydromorphone and 0.08% ropivacaine for epidural labor analgesia, For those in Group 2 : they will be administered with17.5 ug/ml hydromorphone and 0.08% ropivacaine for epidural labor analgesia, For those in Group 3 : they will be administered with 20 ug/ml hydromorphone and 0.08% ropivacaine for epidural labor analgesia, For those in Group 4 : they will be administered with 0.4 ug/ml sufentanil and 0.08% ropivacaine for epidural labor analgesia.
The goal of this clinical trial is to provide a new treatment option for pregnant women in epidural labor analgesia, and to provide a basis for hydromorphone combined with ropivacaine in epidural labor analgesia.

Start Date17 Sep 2023

Sponsor / Collaborator

Maternal and Child Health Hospital of Hubei Province

CTRI/2023/08/056632 / Not yet recruitingNot ApplicableIIT

A PROSPECTIVE RANDOMIZED CONTROL STUDY COMPARING INTRATHECAL HYPERBARIC 0.75% ROPIVACAINE AND HYPERBARIC 0.5% BUPIVACAINE IN PATIENTS UNDERGOING LOWER ABDOMINAL AND LOWER LIMB SURGERIES.

Start Date01 Sep 2023

Sponsor / Collaborator-

100 Clinical Results associated with Ropivacaine Mesylate

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100 Translational Medicine associated with Ropivacaine Mesylate

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100 Patents (Medical) associated with Ropivacaine Mesylate

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15

Literatures (Medical) associated with Ropivacaine Mesylate

01 Dec 2024·CNS Drugs

Long-Term (12-Month) Safety and Tolerability of STS101 (Dihydroergotamine Nasal Powder) in the Acute Treatment of Migraine: Data from the Phase 3 Open-Label ASCEND Study

Article

Author: Tepper, Stewart J ; Rapoport, Alan M ; Ailani, Jessica ; Kirby, Louis ; Albrecht, Detlef ; Strom, Shannon

BACKGROUND AND OBJECTIVESTS101 is an investigational drug-device combination comprising 5.2 mg dihydroergotamine (DHE) powder (6.0 mg DHE mesylate) in a single-use nasal delivery device for the acute treatment of migraine. The primary objective of the ASCEND trial was to assess long-term safety and tolerability of STS101 in the acute treatment of migraine attacks across 12-18 months, with secondary objectives describing efficacy.METHODSASCEND was an open-label study of STS101 in adults aged 18-65 years with a ≥ 1 year history of migraine with or without aura, with onset before the age of 50 years and 4-12 migraine attacks/month and < 15 headache days/month in each of the 3 months prior to screening. Exclusion criteria included diagnosis of non-migraine headache, history of cerebrovascular disease, and ≥ 2 cardiovascular risk factors. After establishing eligibility, participants could self-administer STS101 5.2 mg as needed for up to 2 doses within 24 h to treat a single migraine attack and up to 12 doses/month. Safety and tolerability evaluations included physical and nasal examinations, vital signs, laboratory tests, and treatment-emergent adverse event (TEAE) assessments. Participants used an electronic diary to record exploratory efficacy parameters, including intensity of headache pain and associated migraine symptoms (photophobia, phonophobia, and nausea). Participant impression questions were asked at months 3, 6, and 12.RESULTSOf the 6610 migraine attacks treated with a total of 8234 STS101 doses in 344 participants, 945/6610 (14.3%) were associated with a TEAE. Events were predominantly mild or moderate in nature and rarely led to premature study discontinuation (15/344 [4.4%] participants). Treatment was associated with rapid onset of freedom from pain (36.6%, 67.1%, and 85.5% of treated attacks 2, 4, and 24 h post-dose, respectively), freedom from most bothersome symptoms (54.3%, 79.6%, and 91.3%), and headache relief (66.5%, 89.1%, and 94.3%). Most participants rated treatment results as good or very good and ease of use as easy or very easy at all time points (months 3, 6, and 12) and indicated they were likely or very likely to use STS101 again.CONCLUSIONSThe repeated long-term, as-needed use of STS101 was well tolerated, demonstrating a favorable safety profile in the acute treatment of migraine attacks in appropriately indicated adults. Exploratory efficacy evaluations indicated beneficial effects, which warrant further evaluation.TRIAL REGISTRATIONClinicalTrials.gov identification NCT04406649.

01 Jan 2023·Sichuan da xue xue bao. Yi xue ban = Journal of Sichuan University. Medical science edition

[Effect of Ropivacaine Combined with Dexmedetomidine for Serratus Anterior Plane Block Plus Patient-Controlled Intravenous Analgesia on Postoperative Recovery Quality of Patients Undergoing Thoracoscopic Radical Resection of Lung Cancer].

Article

Author: Cao, Liang-Liang ; Dong, Nan ; Zhang, Ji-Ru ; Jian, Jin-Jin

ObjectiveTo study the postoperative analgesic effect of ropivacaine combined with dexmedetomidine for serratus anterior plane block (SAPB) under ultrasound visualization plus patient-controlled intravenous analgesia (PCIA) in patients undergoing thoracoscopic radical resection of lung cancer.MethodsA total of 129 patients undergoing elective thoracoscopic surgery were enrolled. The patients were randomly assigned to three groups ( n=43 in each group), a normal saline group (control group), a ropivacaine mesylate group (Group R) and a ropivacaine mesylate combined with dexmetomidine hydrochloride group (Group RD). After operation, ultrasound-guided SAPB was performed and patients in the three groups received the injection of 0 mL of 0.9% normal saline, 25 mL of 0.5% ropivacaine, and 25 mL of 0.5% ropivacaine+1 μg/kg dextrometomidine hydrochloride mixture, respectively. In addition, PCIA was used for all the patients. The button on the PCIA pump was pressed when the postoperative pain visual analogue score (VAS)≥4 on coughing, and rescue analgesic of sufentanil was given intravenously at 2.5 μg/bolus. The primary outcome was the VAS scores at rest and on coughing at 10 min (T ₁), 6 h (T ₂), 12 h (T ₃), 24 h (T ₄), and 48 h (T ₅) after extubation. The secondary outcomes included hemodynamics, the quality of sleep for the first 3 nights after operation, number of times the button on the PCIA pump was pressed, intraoperative and postoperative opioid dosage, time of first postoperative rescue analgesic, duraion of intubation, length of stay at the hospital, adverse reactions, etc.ResultsCompared with those of the control group, the VAS scores of the Group R and Group RD were significantly lower at 10 min, 6 h, and 12 h after extubation ( P<0.05). In comparison with Group R, the number of patients requiring rescue analgesia, the time of first postoperative rescue analgesic, the number of times the button on the PCIA pump was pressed, and the total dose of rescue sufentanil were all significantly lower ( P<0.05) in the Group RD. Patients in the Group RD had better sleep quality in the second and third nights after operation and lower incidence of nausea and vomiting ( P<0.05).Conclusion0.5% ropivacaine and 1 μg/kg dexmedetomidine SAPB combined with PCIA can significantly reduce postoperative pain and improve postoperative recovery quality in patients undergoing thoracoscopic radical resection of lung cancer.

01 Feb 2022·Journal of Infection and Public HealthQ3 · MEDICINE

Covid-19 and Artificial Intelligence: Genome sequencing, drug development and vaccine discovery

Q3 · MEDICINE

ReviewOA

Author: Ibrahim, Nahla Khamis ; Abubaker Bagabir, Sali ; Abubaker Bagabir, Hala ; Hashem Ateeq, Raghdah

OBJECTIVESTo clarify the work done by using AI for identifying the genomic sequences, development of drugs and vaccines for COVID-19 and to recognize the advantages and challenges of using such technology.METHODSA non-systematic review was done. All articles published on Pub-Med, Medline, Google, and Google Scholar on AI or digital health regarding genomic sequencing, drug development, and vaccines of COVID-19 were scrutinized and summarized.RESULTSThe sequence of SARS- CoV-2 was identified with the help of AI. It can help also in the prompt identification of variants of concern (VOC) as delta strains and Omicron. Furthermore, there are many drugs applied with the help of AI. These drugs included Atazanavir, Remdesivir, Efavirenz, Ritonavir, and Dolutegravir, PARP1 inhibitors (Olaparib and CVL218 which is Mefuparib hydrochloride), Abacavir, Roflumilast, Almitrine, and Mesylate. Many vaccines were developed utilizing the new technology of bioinformatics, databases, immune-informatics, machine learning, and reverse vaccinology to the whole SARS-CoV-2 proteomes or the structural proteins. Examples of these vaccines are the messenger RNA and viral vector vaccines. AI provides cost-saving and agility. However, the challenges of its usage are the difficulty of collecting data, the internal and external validation, ethical consideration, therapeutic effect, and the time needed for clinical trials after drug approval. Moreover, there is a common problem in the deep learning (DL) model which is the shortage of interpretability.CONCLUSIONThe growth of AI techniques in health care opened a broad gate for discovering the genomic sequences of the COVID-19 virus and the VOC. AI helps also in the development of vaccines and drugs (including drug repurposing) to obtain potential preventive and therapeutic agents for controlling the COVID-19 pandemic.

1

News (Medical) associated with Ropivacaine Mesylate

19 Apr 2023

·www.prnewswire.com

Cali Biosciences Initiates Phase III Studies of CPL-01 (Long-Acting Ropivacaine) to Decrease Post-Operative Pain and Reduce or Eliminate Opioid Use

- Subjects in Herniorrhaphy Study Dosed - Successful FDA Interactions on Two Pre-clinical Pipeline Products Also Discussed SAN DIEGO, April 18, 2023 /PRNewswire/ -- Cali Biosciences Co., Ltd. (hereinafter referred to as "Cali" or "Cali Biosciences"), a biopharmaceutical company focused on the research and development of innovative drugs in the peri-operative space, announced it has initiated Phase III studies of its core product, CPL-01 (long-acting ropivacaine), with dosing in hernia patients already begun and dosing in bunion patients scheduled to start next month. CPL-01 is an extended-release injectable version of Naropin® (ropivacaine hydrochloride), developed by Cali to treat post-operative surgical pain and reduce or eliminate the need for opioids. Dr. Todd Bertoch, a principal investigator in this study, said, "Having been involved in some of Cali's Phase II studies, I really look forward to CPL-01 showing its excellent results and safety profile in Phase III. I have helped to study other long-acting local anesthetics prior to their approval, and am especially excited for this as it is positioned to be the first long-acting ropivacaine to hit the market." Dr. Erol Onel, Chief Medical Officer at Cali Biosciences US, LLC who has developed several other long-acting local anesthetics, agreed and stated, "it is widely accepted that ropivacaine has a better safety profile than bupivacaine, so moving ahead with a long-acting ropivacaine just made sense – the next step in the evolution of non-opioid pain control." Mr. PJ Chen, Chief Executive Officer of Cali Biosciences, commented, "CPL-01 is the core product of Cali Biosciences' product pipeline in the peri-operative space, and initiating enrollment in our phase III clinical trials is an important milestone in CPL-01's R&D progress. We are confident that the phase III results will build on our successful Phase II results, and add to the encouraging data we've seen so far so we can provide a new and better option for doctors and patients seeking post-operative pain management – including opioid reduction or elimination - as quickly as possible." He added "We have also had successful recent interactions with the FDA regarding two of our pre-clinical pipeline products, with clear and thoughtful guidelines provided for development of a suite of products that could help serve doctors and patients around the world." About CPL-01 CPL-01 is an extended-release injectable formulation of Naropin® (ropivacaine hydrochloride), which is a member of the amino amide class of local anesthetics indicated for the production of local or regional anesthesia for surgery and acute pain management. Naropin® (ropivacaine hydrochloride) Injection is approved for local or regional anesthesia for surgery and for acute pain management. However, because of the short duration of effect, frequent injections or infusion by catheter are required if protracted local analgesia is required for postoperative pain management. As a result, Cali Biosciences has developed CPL-01 based on Naropin® Injection and PG-Depot technology platform in order to prolong its duration at the local site, leading to an extended local analgesic effect. About Cali Biosciences Cali Biosciences Co., Ltd. was established in Cayman Islands in 2021. Cali Biosciences US, LLC was established in San Diego in 2016, and later Cali Biosciences built its global headquarters in Shenzhen and established a research and development team in Shanghai. Cali Biosciences is an innovative international biopharmaceutical company with a number of licensed independent research and development technology platforms, as well as an international scientific research and management team. It has been committed to R&D, production and sales for innovative clinical drugs in the surgical perioperative field to fully respond to unmet clinical and market needs. Cali Biosciences' product pipeline includes modified formulations and new drugs in the fields of anesthesia, analgesia and anti-inflammatory. The company is committed to serving patients and medical staff around the world. SOURCE Cali Biosciences

Phase 2Phase 3Drug Approval

100 Deals associated with Ropivacaine Mesylate

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KEGG	Wiki	ATC	Drug Bank
-	-	N01BB09	DB00296

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Anesthesia	CN	-	-

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Clinical Result

Indication

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04474366 (CTgov)	Phase 4	Opioid abuse \| Pain, Postoperative	50	Saline (0.9%) (Saline)	cxzoepaiml(lphttiwxyp) = gngojswpkw vecpzdkbds (pfunhmdnct, cxaxwxabof - lhlfqtsaui) View more	-	26 Jun 2023
				Ropivacaine 0.2% Injectable Solution (Ropivacaine)	cxzoepaiml(lphttiwxyp) = pxlgcqodmw vecpzdkbds (pfunhmdnct, ahmsfzwgmj - cvrozcfudw) View more
NCT04558281 (CTgov)	Phase 4	Rib Fractures \| Anesthesia	4	Active ropivacaine 0.3% erector spinae plane perineural administration (Active Treatment)	svhnlfbhbi(uawyljcpjf) = dzpgdwqdup cughvpwrdd (ablpxxxabv, tveqbtcmzz - nqifexhevr) View more	-	12 Jun 2023
				Placebo erector spinae plane perineural administration (Placebo)	svhnlfbhbi(uawyljcpjf) = gapqhqmike cughvpwrdd (ablpxxxabv, bwnwvstyql - qsdfcjcxdd) View more
NCT03746951 (CTgov)	Phase 2/3	Musculoskeletal Diseases \| Pain	15	Ropivacaine Hcl 0.5% Inj Vil 20Ml (Fascia Iliaca Compartment Block (FICB))	bvamibsiol(mcesknybdd) = aejpbrydqa rbfifwpvgy (tpkggiefbi, wutvatfssx - rflqbuyzle) View more	-	03 Mar 2022
				Ropivacaine Hcl 0.5% Inj Vil 20Ml (Lumbar Plexus Block (LPB))	bvamibsiol(mcesknybdd) = pcwfizcskg rbfifwpvgy (tpkggiefbi, uvghtlxybr - hmzexzrish) View more
NCT00912873 (CTgov)	Phase 4	Disorder of hip region	50	0.1% Ropivacaine (0.1% Ropivicaine)	jxooezhdwk(qmggjcvvtr) = ytaqsfwfbx swutelwpjx (chekflmwap, jserlsuenv - iypqvumjxl) View more	-	11 Mar 2021
				0.4% Ropivacaine (0.4% Ropivicaine)	jxooezhdwk(qmggjcvvtr) = hgvbdebqdf swutelwpjx (chekflmwap, aoynxsxfgz - lyexvorzmv) View more
NCT03154658 (CTgov)	Phase 4	Pain, Postoperative	66	Ropivacaine 0.35% (Sub-serratus Regional Block)	(ianmymzpfb) = yuscafrbtc iadoamwcci (zkynfbntpx, cblcezsbir - epcgsfiaga) View more	-	24 Feb 2021
				Ropivacaine 0.35% (Supra-serratus Regional Block)	(ianmymzpfb) = mzzovvpgiv iadoamwcci (zkynfbntpx, rhspgkyqxa - emuqeleeux) View more
NCT04005404 (CTgov)	Not Applicable	Hip Fractures	80	Ropivacaine (sciatic nerve block) (Intertrochanteric Femoral Fractures)	yytzoosmvy(ubjabrzzrw) = kdtgdqkrvr qszahkhkkc (dzdomxtjwe, zvvnfzqzuj - pedtzqqmfq) View more	-	18 Feb 2021
				Ropivacaine (sciatic nerve block) (Neck Femur Fractures)	yytzoosmvy(ubjabrzzrw) = duqekvifnn qszahkhkkc (dzdomxtjwe, ncoiasfsop - gcxzzzebzi) View more
NCT03309163 (Pubmed \| Front Med (Lausanne))	Phase 4	Depression, Postpartum	1,230	Tramadol PCIA	rdysqcprqa(tsegbnnffv) = cndhtjllqb jcacxnxsjn (cfxvokjfoa )	-	01 Jan 2021
				Hydromorphone PCIA	rdysqcprqa(tsegbnnffv) = ptcjyxbktd jcacxnxsjn (cfxvokjfoa )
NCT02798835 (CTgov)	Phase 4	Pain	180	Adductor canal block+Ropivacaine 0.5% Injectable Solution+Fentanyl+Bupivacaine (Adductor Canal Block)	odvyxubdql(yrhqkzmsak) = eipufoeccg pfnpgmbzke (cawmbgwihi, nrtbrnmbtx - wuigojpsci) View more	-	04 Sep 2020
				Adductor canal block+Ropivacaine 0.5% Injectable Solution+Fentanyl+Dexamethasone+Bupivacaine (Adductor Canal Block With Dexamethasone)	odvyxubdql(yrhqkzmsak) = lrzpiawqaa pfnpgmbzke (cawmbgwihi, sjvaqwygqm - ykxvkgmgyy) View more
NCT01094106 (CTgov)	Phase 4	Pain, Postoperative	70	Ropivacaine 0,75% (Ropivacaine 0,75%)	jibjvkywvo(aijwkdrzpq) = onqznffmqg gqvrirsjnz (bxqfjasyjj, ibwlnaazhd - rxvdawafnj) View more	-	18 Aug 2020
				NaCl 0,9% (NaCl 0,9%)	jibjvkywvo(aijwkdrzpq) = girreonpts gqvrirsjnz (bxqfjasyjj, qnwhcdjkka - vrzmwfpxkw) View more
NCT02579629 (CTgov)	Phase 4	Analgesia	64	On-Q ® elastomeric pump+Ropivacaine 0.1% (Ropivacaine 0.1%)	tazhfakkbg(ozmsbmvnsu) = fdtfkjphpk bjsrfnyfwr (dgmydlyiuj, lubyukbrar - fscalwbdhq) View more	-	12 Aug 2020
				On-Q ® elastomeric pump+Ropivacaine 0.2% (Ropivacaine 0.2%)	tazhfakkbg(ozmsbmvnsu) = nbtnmnzeuv bjsrfnyfwr (dgmydlyiuj, kwzrrpmflr - hxnxgsjqil) View more