A Randomized, Single-blind, Parallel-controlled Clinical Study to Evaluate the Safety and Efficacy of Remimazolam Besylate Combined With Alfentanil in Anesthesia for Thoracic Surgery

Title: A Clinical Study Comparing Two Anesthesia Methods for Chest Surgery
Why is this study being done? Chest surgeries (like lung surgery) require safe and stable anesthesia. Currently, a drug called propofol combined with an opioid painkiller (alfentanil) is commonly used. However, propofol can sometimes cause low blood pressure and low oxygen levels. A newer drug called remimazolam may cause fewer of these side effects. This study aims to compare the safety and effectiveness of remimazolam (combined with alfentanil) versus propofol (combined with alfentanil) for anesthesia during chest surgery.
What will happen in the study?
Patients scheduled for elective chest surgery will be invited to participate. If they agree, they will be randomly assigned (like flipping a coin) to one of two groups:
* Group 1: Will receive remimazolam and alfentanil for anesthesia.
* Group 2: Will receive propofol and alfentanil for anesthesia (standard care).
The anesthesiologist will carefully monitor patients during and after surgery. We will mainly compare how often patients in each group experience two safety issues: low oxygen levels in the blood and low blood pressure. We will also record recovery times, drug doses, side effects, and ask patients and surgeons about their satisfaction.
Who can participate? Adults aged 18-65 who are scheduled for elective chest surgery and are in relatively stable health (ASA physical status I-III).
Where is the study taking place? This study will be conducted in the Department of Anesthesiology at The First Affiliated Hospital of Xinxiang Medical College, Henan, China.
Ethics Approval:
This study has been reviewed and approved by the Ethics Committee of The First Affiliated Hospital of Xinxiang Medical College (Approval Number: (2025) Medical Ethics Committee Approval No. 29).

Start Date01 Mar 2026

Sponsor / Collaborator

The First Affiliated Hospital of Xinxiang Medical College

NCT07395596

/ RecruitingPhase 4IIT

A Prospective, Randomized Controlled Clinical Study of the Effect of Remimazolam on the Incidence of Hypoxia in High-risk Patients Undergoing Painless Tracheoscopy

Bronchoscopy is currently widely used for the diagnosis and treatment of various respiratory diseases. However, the operation of bronchoscopy is irritating, causes a strong stress response, and shares the airway with the patient, making the patient highly susceptible to respiratory and cardiovascular risks. Among these risks, hypoxia is the most common adverse event.Different drug regimens can be selected for anesthesia under deep sedation. The combination of analgesic agents can help reduce coughing during bronchoscopy. Therefore, we employ a combination of sedative and analgesic drugs for painless bronchoscopy procedures. Among sedatives, propofol is the most commonly used. However, due to its disadvantages, such as respiratory and circulatory depression, we have introduced a novel approach combining remimazolam for sedation. The aim is to investigate whether this new regimen, compared to traditional propofol-based sedation, can reduce the incidence of hypoxia, minimize circulatory depression, and lead to faster postoperative awakening and recovery. Additionally, we hope to observe fewer adverse events, such as perioperative nausea and vomiting, excessive secretions, dizziness, and chills.

Start Date09 Feb 2026

Sponsor / Collaborator

The First Affiliated Hospital, Zhejiang University Sch of Med

[+1]

100 Clinical Results associated with Alfentanil Hydrochloride

100 Translational Medicine associated with Alfentanil Hydrochloride

100 Patents (Medical) associated with Alfentanil Hydrochloride

2,696

Literatures (Medical) associated with Alfentanil Hydrochloride

01 Jan 2026·ANESTHESIA AND ANALGESIA

Pharmacokinetics and Pharmacodynamics of Analgesic and Anesthetic Drugs in Patients During Cardiac Surgery With Cardiopulmonary Bypass: A Narrative Review

Review

Author: Hermanns, Henning ; Eleveld, Douglas ; Saatpoor, Aryen ; Hollmann, Markus ; Breel, Jennifer ; Eberl, Susanne ; Beukers, Anne ; Kluin, Jolanda ; van den Brom, Charissa

Cardiopulmonary bypass (CPB) impacts pharmacokinetics and -dynamics of drugs used during cardiac surgery. These alterations can lead to changes in drug efficacy resulting in under- or overdosing. This review summarizes current knowledge on the effects of CPB on commonly used intraoperative and continuously administered anesthetics and analgesics. Out of 197 articles initially identified, 22 were included in the final review. The breakdown of studies by main topic was as follows: propofol (9 articles), sevoflurane (4), remifentanil (3), isoflurane (2), fentanyl (2), and sufentanil (2), and alfentanil (1). The initiation of CPB typically results in hemodilution and hypothermia, leading to a decrease in total plasma concentration combined with an increase in unbound plasma concentrations. This phenomenon has varying implications for different drugs: For propofol and sevoflurane, lower doses may be required during CPB to achieve the same anesthetic effect. Fentanyl and sufentanil plasma concentrations decrease by 25% on average at CPB initiation due to an increased volume of distribution, followed by an increase during CPB, with sufentanil, showing an almost 50% increase post-CPB. This implies that an additional bolus before CPB initiation should be considered, followed by a reduction of the maintenance dose to prevent prolonged sedation. Remifentanil plasma concentration decreases at CPB initiation, which implies that higher initial- or adjusted maintenance dose should be considered in normothermic patients. However, under hypothermic conditions, infusion rates should be decreased by 30% for every 5°C decrease in temperature. Alfentanils, total plasma concentration decreases during CPB, while its free fraction remains unaltered, indicating that no further adjustments are necessary. Target-controlled infusion (TCI) models for propofol (Schnider, Marsh, and PGIMER [Postgraduate Institute of Medical Education and Research]) and remifentanil (Minto) were found to be inaccurate in the context of CPB. Based on the included studies, the use of these pharmacokinetic models is not recommended. In conclusion, dosing inaccuracies resulting in adverse events in on-pump cardiac surgery underscore the importance of understanding the pharmacokinetics and -dynamics of anesthetic and analgesic drugs during CPB. The clinical implication of the altered drug responses after CPB remains challenging in this high-risk population. Key takeaways include the necessity of considering patient-specific factors, utilizing objective monitoring tools, and recognizing potential drug alterations due to CPB.

01 Jan 2026·ACTA ANAESTHESIOLOGICA SCANDINAVICA

Patient‐Controlled Sedation in Port Implantation ( PACSPI 2)—A Randomised Clinical Trial

Article

Author: Taxbro, Knut ; Seifert, Stefanie ; Azman, Josip ; Chew, Michelle S. ; Nilsson, Andreas ; Hammarskjöld, Fredrik

ABSTRACT:

Optimising pain management during subcutaneous venous port (SVP) implantation is essential for patient‐centred cancer care. However, evidence‐based approaches to minimise intraoperative pain remain underexplored. This trial evaluated the clinical effectiveness and safety of the propofol‐alfentanil patient‐controlled sedation (PCS) technique as an adjunct to local anaesthesia (LA) for pain reduction during SVP implantation. Adult cancer patients at two Swedish anaesthesia departments received either LA + PCS or LA alone for SVP implantation. The primary outcome was the maximum intraoperative pain score on an 11‐point numeric rating scale (NRS). Safety outcomes included respiratory, haemodynamic and insertion‐related complications. Secondary outcomes assessed patient satisfaction and procedural measurements. A total of 340 patients (median age 70 [interquartile range, [IQR] 61–76], 51.8% male) were recruited between January 2023 and November 2024. Median intraoperative NRS pain scores were similar between groups (2 [0–3] vs. 2 [0–3], p = 0.292), with pain scores ≥ 4 reported in 22.9% (LA + PCS) and 22.2% (LA) (OR 0.96; 95% CI 0.57–1.60; p = 0.872). Hypoxia or obstructed airway occurred in 2/166 (1.2%) patients in the LA + PCS group and none in the LA group. Patient satisfaction was high in both groups (10 [10–10], p = 0.102). Optimal procedural conditions were reported more frequently with LA + PCS (96.4% vs. 82.0%; OR 5.84; 95% CI 2.36–14.44; p < 0.001), without affecting perioperative workflow. Propofol‐alfentanil PCS does not significantly reduce intraoperative pain in patients during SVP implantation. Its routine use for pain reduction cannot be recommended. However, PCS may reasonably be offered to patients who prefer procedural sedation.

Editorial Comment:

This randomised clinical trial found that adding patient‐controlled sedation with propofol‐alfentanil to standard local anaesthesia for subcutaneous venous port implantation does not have an impact on pain scores or patient satisfaction. Additional studies focusing on patients experiences and safety are recommended before implementing propofol‐alfentanil patient‐controlled sedation.Trial Registration: EudraCT number: 2021‐003821‐31; ClinicalTrials.gov identifier: NCT 05688384.

01 Nov 2025·JOURNAL OF CLINICAL ANESTHESIA

Precision sedation with novel single syringe multimodal opioid or non-opioid 6–2-2 mixtures

Article

Author: Grogan, Tristan ; Wingert, Theodora ; Fang, Zhuang T ; MacDougall, Natalia ; Zamora, Alan ; Nguyen-Buckley, Christine

OBJECTIVES:

The purpose of this study is to determine the efficacy and safety of sedation/analgesia using mixtures of propofol, opioids or non-opioid sedatives, and lidocaine or etomidate in one single syringe.

DESIGN:

A retrospective case review was undertaken.

SETTING:

University outpatient surgical center.

PATIENTS:

1,376 adult patients undergoing ophthalmic surgery with ocular blocks and monitored anesthesia care were studied.

INTERVENTION:

The 6 opioid-based mixtures contained 6 portions of propofol, 2 portions of opioid (alfentanil, fentanyl, a combination of alfentanil and fentanyl, or alfentanil and hydromorphone), and 2 portions of lidocaine or ketamine in a single syringe, in a 6:2:2 volume ratio. The non-opioid mixture contained 6 portions of propofol, 2 portions of ketamine, and 2 portions of etomidate. A bolus dose for all mixtures was calculated based on the patient's age and weight: < 40 yr, 1.2 mL/10 kg; 40-59 yr, 1 mL/10 kg; 60-69 yr, 0.8 mL/10 kg; 70-84 yr, 0.6 mL/10 kg; ≥85 yr, 0.5 mL/10 kg, and delivered by hand push or infusion pump intravenously (IV). For patients with a body mass index (BMI) >25, the adjusted weight for dosing (AWFD) was used: AWFD = ideal body weight (IBW) + 0.3 x (Actual weight [AW] - IBW). Ocular blocks were performed when patients reached a moderate level of sedation. Blood pressure (BP), heart rate (HR), oxygen saturation, clinical signs of sedation, responses to blocks, apnea and need for airway support, and recall were recorded.

MEASUREMENT AND MAIN RESULTS:

91 %-98 % of all patients had no pain during ocular blocks and 98-99 % had no head movement, except in the KE6-2-2 without K10 (bolus only) group. The readiness time was 46-51 s for the opioid groups and 36- 43 s for the non-opioid groups. In the opioid groups, 97 %-99 % had no apnea and 88 %-94 % had no oxygen desaturation, while 99 % had no apnea and 96 % had no oxygen desaturation in the non-opioid groups. Heart rate and blood pressure decreased <10 % in the opioid groups while there was nearly no change in the non-opioid groups.

CONCLUSION:

Adjusted for age and weight, the bolus dose of the 6-2-2 mixture met the sedation requirements for ocular blocks in most patients with favorable outcomes and minimal airway or hemodynamic compromise regardless of which mixture was used.

News (Medical) associated with Alfentanil Hydrochloride

20 Oct 2025

·www.prnewswire.com

Endo Launches First and Only Generic Version of RAVICTI® (glycerol phenylbutyrate) Oral Liquid in the United States

Endo announces the U.S. launch of a generic version of RAVICTI® (glycerol phenylbutyrate), marking a significant milestone as a new generic treatment option for patients with urea cycle disorders. The generic formulation offers a new option for both adult and pediatric patients managing rare metabolic conditions. This launch represents a key first-to-market generic entry for Endo, reinforcing a focus on complex generics. MALVERN, Pa., Oct. 20, 2025 /PRNewswire/ -- Endo, a wholly-owned subsidiary of Mallinckrodt plc, announced today the launch of a generic version of Amgen's RAVICTI® (glycerol phenylbutyrate), 1.1 gm/mL oral liquid, following final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application. Endo's glycerol phenylbutyrate is the first and currently the only FDA-approved generic version of RAVICTI® available in the U.S. "This first-to-market launch of generic RAVICTI® oral liquid is a meaningful milestone for Endo and important for our Generics business as we near the planned spin-off of Par Health," said Scott Sims, Senior Vice President and General Manager, Endo Injectable Solutions and Generics. "It expands access for patients and providers, and reinforces our commitment to quality, reliability, and leadership in complex generics." Glycerol phenylbutyrate oral liquid is indicated for use as a nitrogen-binding agent for chronic management of patients with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. Glycerol phenylbutyrate oral liquid must be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements). RAVICTI® is a registered trademark of Amgen, Inc. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Glycerol phenylbutyrate oral liquid is contraindicated in patients with known hypersensitivity to phenylbutyrate. Signs of hypersensitivity include wheezing, dyspnea, coughing, hypotension, flushing, nausea, and rash. WARNINGS AND PRECAUTIONS Neurotoxicity - Increased exposure to phenylacetate (PAA), the major metabolite of glycerol phenylbutyrate, may be associated with neurotoxicity in patients with UCDs. Signs and symptoms of potential PAA neurotoxicity were reported at plasma PAA concentrations above 500 micrograms/mL and included somnolence, fatigue, lightheadedness, headache, dysgeusia, hypoacusis, disorientation, impaired memory, and exacerbation of preexisting neuropathy. If symptoms of vomiting, nausea, headache, somnolence, or confusion are present in the absence of high ammonia or other intercurrent illness which explains these symptoms, consider the potential for PAA neurotoxicity which may need reduction in the glycerol phenylbutyrate dosage. Pancreatic Insufficiency or Intestinal Malabsorption - Exocrine pancreatic enzymes hydrolyze glycerol phenylbutyrate in the small intestine, separating the active moiety, phenylbutyrate, from glycerol. Low or absent pancreatic enzymes or intestinal disease resulting in fat malabsorption may result in reduced or absent digestion of glycerol phenylbutyrate and/or absorption of phenylbutyrate and reduced control of plasma ammonia. Monitor ammonia levels closely in patients with pancreatic insufficiency or intestinal malabsorption. ADVERSE REACTIONS Adult patients: The most common adverse reactions (occurring in at least 10% of patients) reported during short-term treatment (4-week study, n=45) with glycerol phenylbutyrate were diarrhea, flatulence, and headache. Other adverse reactions reported in at least 10% of adult patients (12-months of treatment, n=51) were nausea, vomiting, diarrhea, decreased appetite, dizziness, headache, and fatigue. Pediatric patients ages 2–17 years: Adverse reactions reported in at least 10% of pediatric patients ages 2 years to 17 years (n=26) were upper abdominal pain, rash, nausea, vomiting, diarrhea, decreased appetite, and headache. Pediatric patients ages 2 months to less than 2 years: Adverse reactions reported in at least 10% of pediatric patients aged 2 months to less than 2 years (n=17) were neutropenia, vomiting, constipation, diarrhea, pyrexia, hypophagia, cough, nasal congestion, rhinorrhea, rash, and papule. Pediatric patients less than 2 months of age: Adverse reactions reported in at least 10% of pediatric patients aged less than 2 months (n=16) were vomiting, rash, gastroesophageal reflux, increased hepatic enzymes, feeding disorder (decreased appetite, hypophagia), anemia, cough, dehydration, metabolic acidosis, thrombocytosis, thrombocytopenia, neutropenia, lymphocytosis, diarrhea, flatulence, constipation, pyrexia, lethargy, and irritability/agitation. Postmarketing Experience: The following adverse reactions have been identified during post-approval use of glycerol phenylbutyrate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Abnormal body odor, including from skin, hair, and urine Retching and gagging Dysgeusia or burning sensation in mouth DRUG INTERACTIONS Potential for Other Drugs to Affect Ammonia Levels: Corticosteroids - May cause the breakdown of body protein and increase plasma ammonia levels. Monitor ammonia levels closely when used concomitantly with glycerol phenylbutyrate. Valproic Acid and Haloperidol - These drugs may induce hyperammonemia. If used in UCD patients receiving glycerol phenylbutyrate, close monitoring of plasma ammonia levels is advised. Potential for Other Drugs to Affect Glycerol Phenylbutyrate: Probenecid - May inhibit renal excretion of glycerol phenylbutyrate metabolites including phenylacetylglutamine (PAGN) and PAA. Potential for Glycerol Phenylbutyrate to Affect Other Drugs: Drugs with a Narrow Therapeutic Index (CYP3A4 Substrates) - Glycerol phenylbutyrate is a weak CYP3A4 inducer. Concomitant use of glycerol phenylbutyrate may decrease the systemic exposure to drugs that are substrates of CYP3A4. Monitor for decreased efficacy of drugs with a narrow therapeutic index (e.g., alfentanil, quinidine, cyclosporine). Midazolam - Systemic exposure to midazolam may be reduced when used with glycerol phenylbutyrate. Monitor for suboptimal clinical effects of midazolam in patients who are being treated with glycerol phenylbutyrate. USE IN SPECIFIC POPULATIONS Pediatric Use - Safety and efficacy have been established in pediatric patients. Geriatric Use - Clinical studies did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently. Dose selection should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Pregnancy - The limited available data for the use of glycerol phenylbutyrate in pregnant women is insufficient to inform a drug-associated risk of major birth defects and miscarriage. Lactation - There are no data on the presence of glycerol phenylbutyrate in human milk, the effects on the breastfed infant, or the effects on milk production. Because of the potential for serious adverse reactions, including neurotoxicity and tumorigenicity in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with glycerol phenylbutyrate. Hepatic Impairment - Because conversion of PAA to PAGN occurs in the liver, patients with hepatic impairment may have reduced conversion capability and higher plasma PAA and PAA to PAGN ratio. Therefore, dosage for patients with moderate to severe hepatic impairment should be started at the lower end of the recommended dosing range and should be kept on the lowest dose necessary to control their ammonia levels. Renal Impairment - The efficacy and safety of glycerol phenylbutyrate in patients with renal impairment are unknown. Monitor ammonia levels closely when starting patients with impaired renal function on glycerol phenylbutyrate. Click for Full Prescribing Information. About Endo Endo, a wholly owned subsidiary of Mallinckrodt plc, is a diversified therapeutics manufacturer boldly transforming insights into life-enhancing therapies. Our passionate team members collaborate to develop and deliver these essential medicines. Together, we are committed to helping everyone we serve live their best life. Learn more at or connect with us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements This release contains forward-looking statements, including with regard to product efficacy, potential treatments or indications, therapeutic outcomes or treatment responses, and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: the effects of each of Endo's and Mallinckrodt's recent emergences from bankruptcy; satisfaction of, and compliance with, regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; changes in market demand; issues with product quality, manufacturing or supply, or patient safety issues or adverse side effects or adverse reactions associated with our products; and other risks identified and described in more detail in the "Risk Factors" and the "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Endo's and Mallinckrodt's most recent Annual Reports on Form 10-K, Mallinckrodt's Registration Statement on Form S-4, as amended, and other filings with the Securities and Exchange Commission (SEC), all of which are available from the SEC's website () and Mallinckrodt's website (). The forward-looking statements made herein speak only as of the date hereof and we do not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law. SOURCE Endo USA, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug Approval

14 Mar 2025

·www.echemi.com

5 Key Updates on China's Fentanyl Control Amid US Tariffs

On February 1st, the United States announced a 10% tariff on products imported from China, citing concerns over the fentanyl crisis. In response, a spokesperson from the Ministry of Public Security emphasized that China maintains one of the strictest drug control policies in the world. As a signatory to the three UN drug control conventions, China has consistently upheld its international obligations and actively collaborates with countries, including the US, on drug enforcement efforts. In 2019, China took a humanitarian step by becoming the first country to classify all fentanyl-related substances under stringent controls, responding to US requests. Since this classification, China has not received reports of these substances being seized in the US. On March 12th, the National Medical Products Administration (NMPA) shared insights regarding China's management of fentanyl substances through a recently released white paper. The spokesperson addressed concerns about the production and export of fentanyl-related pharmaceuticals. Currently, four fentanyl-related drugs are approved for clinical use in China: fentanyl, sufentanil, remifentanil, and alfentanil. Three companies have been authorized to produce raw materials, while five are permitted to manufacture formulations. In 2024, China produced 100 kilograms of fentanyl raw materials, primarily for domestic medical use and export, with only 12.3 kilograms exported to countries like South Korea, Vietnam, and the Philippines. Notably, China has never exported fentanyl products to North America. All fentanyl-related drugs in China are classified as controlled narcotics, subjected to stringent regulations. The production and distribution of these drugs are closely monitored, with specific companies designated for manufacturing and fixed sales channels established. Export controls require permits, and international verification ensures the legality of trade before issuing export licenses. The NMPA will continue to enhance the supervision of fentanyl-related drug production and strictly regulate exports to prevent illegal channels and misuse, ensuring that medical needs are met responsibly.

Drug Approval

21 Jan 2025

·www.echemi.com

Humanwell Healthcare Secures Major Investment: A New Era Begins with Strategic Backing

After a three-month hiatus, leading domestic anesthetics producer Humanwell Healthcare has officially been "acquired" by a state-backed entity. On January 15, the company announced that it had signed a restructuring investment agreement with Zhaoshang Innovation Technology Group Co., Ltd. and its management team. This collaboration involves an investment of ¥11.8 billion, positioning Zhaoshang Innovation as the new controlling shareholder, with a 23.70% stake in Humanwell Healthcare. The restructuring investment will be executed in two phases. The first phase, covering 60% of the investment, will be paid upon the approval of the restructuring plan by the Wuhan Intermediate People’s Court. The remaining 40% will be paid after the completion of stock and voting rights transfers. Once this restructuring plan is finalized, Humanwell Healthcare will officially transition to state-owned control, a move that has significantly boosted its stock price, reaching ¥23.6 per share and a market capitalization of ¥38.52 billion. A Shift in Leadership: Hope for the "Anesthetic King" Founded in 1993, Humanwell Healthcare was once the dominant force in the anesthetic drugs sector. However, it has faced unprecedented challenges due to its former major shareholder, Dandai Technology, being mired in a debt crisis. Previously, six potential restructuring investors had passed the initial review, including three state-owned enterprises and three large local state-owned enterprises. Dandai Technology’s 23.7% stake in Humanwell Healthcare is currently frozen due to judicial actions. The entry of Zhaoshang Innovation brings a glimmer of hope, with the investment structured in three parts: Direct acquisition of 6% of Humanwell Healthcare’s shares. Indirect acquisition of another 6% through a new limited partnership in the Donghu New Technology Development Zone, with Zhaoshang Innovation as the general partner. Trust plan acquiring 11.70% of shares, with all voting rights delegated to Zhaoshang Innovation. Zhaoshang Innovation is controlled by China Merchants Group, a significant state-owned enterprise headquartered in Hong Kong. In 2023, China Merchants Group reported revenues of ¥924.4 billion and a net profit of ¥191.1 billion, showcasing its robust financial standing. Strategic Investment Amid Market Challenges Zhaoshang Innovation's substantial investment indicates its strategic interest in Humanwell Healthcare's industry-leading position in the pharmaceutical sector. Humanwell Healthcare is one of the few companies capable of producing a full range of fentanyl products and has established a strong foothold in various segments, including anesthetics and steroid hormones. According to the latest data, Humanwell Healthcare holds a 25.9% market share in the anesthetics market, making it the leading player. Its products, including alfentanil and hydromorphone, have a 100% market share, illustrating its dominance. In the past five years, Humanwell Healthcare has invested ¥4.6 billion in research and development, reflecting a commitment to innovation. In 2023, R&D expenses surpassed ¥1 billion, with a 9.2% increase in the first three quarters of 2024. The company has received approval for 1 traditional Chinese medicine and 17 chemical drug products, indicating a robust pipeline for future growth. Despite these positive developments, challenges remain. The competitive landscape is fierce, and the company must ensure that its R&D investments yield proportional returns. The support from Zhaoshang Innovation may provide the necessary impetus for Humanwell Healthcare to navigate these challenges successfully and emerge stronger. With Zhaoshang Innovation taking a controlling stake, Humanwell Healthcare's ownership issue has reached a significant resolution. This strategic investment from a state-owned entity sends positive signals to the market. However, the company still faces challenges related to market competition and R&D efficiency. Observers will be keen to see if Humanwell Healthcare can leverage this new partnership to overcome its obstacles and achieve a successful turnaround.

AcquisitionDrug Approval

100 Deals associated with Alfentanil Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D00835	Alfentanil Hydrochloride	N01AH02	DB00802

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Anesthesia	United States	Rising Pharmaceuticals, Inc.	29 Dec 1986

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Analgesia	Phase 3	China	Jiangsu Nhwa Pharmaceutical Co., Ltd.	06 Jun 2018
Acute Pain	Phase 3	Czechia	Orexo AB	08 Oct 2012

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ChiCTR2200062034 (Pubmed \| BMC Anesthesiol)	Phase 1	-	96	Alfentanil 20 µg/kg	fxszoimwzu(jmavswwgxp) = rhpcabbqvf kkhspxtnpu (ukfpbkmyny ) View more	Positive	13 Aug 2024
				Alfentanil 25 µg/kg	chzktzlvjw(ammwegwmjf) = kzwervwwjr slpbonnxqk (rasssshcmf )
NCT03359395 (CTgov)	Phase 4	Hypotension	100	Alfentanil (Alfentanil)	ehfjfdqdpb(pzwvjqhylk) = bkrvopylym oabdfrzmrt (ijsucwaotx, 36.968) View more	-	08 Jul 2021
				Placebos (Placebo)	ehfjfdqdpb(pzwvjqhylk) = yywaalmxug oabdfrzmrt (ijsucwaotx, 33.50864) View more
NCT01008059 (CTgov)	Not Applicable	-	6	Alfentanil	zkyzmjizne(cdegtgczlv) = csrcbzktaj sflahygmue (djevekrcvf, 15) View more	-	17 May 2019
NCT01094574 (CTgov)	Not Applicable	Pain \| Inflammation	10	Alfentanil (Alfentanil)	twsjahjanb(nndsgfunze) = pjckwewodw yeocxyezhz (zibsivdavh, 0.74) View more	-	24 Feb 2017
				Propranolol (Propranolol)	twsjahjanb(nndsgfunze) = msekezxbic yeocxyezhz (zibsivdavh, 0.26) View more
NCT00997126 (CTgov)	Phase 4	Sedation	126	propofol (Propofol)	fnvkrnjkxp = eicnaocfwf ehovtkxeql (dyomhnnuix, oxvfwxrbgh - ehutxpdctd) View more	-	27 Jan 2017
				Alfentanil (Alfentanil)	fnvkrnjkxp = jpsxurqxoa ehovtkxeql (dyomhnnuix, uovngvxpqh - hbfomqrxrg) View more
NCT00672438 (CTgov)	Not Applicable	Pain	242	Alfentanil	anejatrtem(szwlmnzijr) = rbmxtwosvu sfvdguwpuy (mederagmfv, hznvkfhybx - caodnfiiwr) View more	-	21 Jul 2016
NCT01470170 (CTgov)	Phase 4	Hypoxia	173	Targeted controlled infusion+propofol+Normal saline+Alfentanil (Group1)	yiymrrkkeo(hqgcxnjckm) = wowslrndpq cwlekfmsco (ivazpvvnpc, 0.4) View more	-	13 Aug 2015
				Targeted controlled infusion+propofol+Normal saline+Alfentanil (Group 3)	yiymrrkkeo(hqgcxnjckm) = xejlturawf cwlekfmsco (ivazpvvnpc, 0.4) View more
NCT00997113 (CTgov)	Phase 4	Sedation	20	propofol (Propofol)	yponsptrgl(sksdlsodhu) = uzhywornkz xvpbxypjyl (dwhsmvbyxv, dmlafcgncc - nkjyepuqjs) View more	-	25 Sep 2014
				propofol+alfentanil (Propofol/Alfentanil)	yponsptrgl(sksdlsodhu) = uwsplouzyj xvpbxypjyl (dwhsmvbyxv, ywtacncpla - irvdvxdmmi) View more
NCT00991809 (0813, CTgov)	Not Applicable	Hyperalgesia	22	Alfentanil (Alfentanil)	xgjmhynrye(qjsqenzufw) = wxpakqyeuf xfxqjscxnv (khodscixlo, qhusfzzmfr - qvnbrlwmup) View more	-	14 Oct 2013
				Diphenhydramine (Diphenhydramine)	xgjmhynrye(qjsqenzufw) = uwbdgdbvxr xfxqjscxnv (khodscixlo, ekopoasflj - eiiqmsikgm) View more
NCT01436799 (CTgov)	Not Applicable	Brain Ischemia	40	desflurane+Rocuronium+alfentanil (Desflurane)	njzfoizcsy(mvviofutsc) = drmksezlxc jpxhlupcue (obnbryvldv, 7) View more	-	26 Aug 2013
				propofol+Rocuronium+alfentanil (Propofol)	njzfoizcsy(mvviofutsc) = rjnhwzsypu jpxhlupcue (obnbryvldv, 9.5) View more

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Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Alfentanil Hydrochloride

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation