A Study on the Efficacy of Haishu San and Antibiotics Administered Concurrently in Wound Healing During Periodontal Treatment -A Randomized Controlled Trial- (A Study on the Efficacy of Haishu San and Antibiotics Administered Concurrently in Wound Healing During Periodontal Treatment )

Start Date21 Jul 2026

Sponsor / Collaborator-

CTR20262120

/ Active, not recruitingNot Applicable

洛索洛芬钠片在健康试验参与者中单中心、随机、开放、两制剂空腹/餐后生物等效性试验

[Translation] A single-center, randomized, open-label, two-formulation bioequivalence study of loxoprofen sodium tablets in healthy participants.

主要目的：以药代动力学参数作为主要终点评价指标，比较在空腹/餐后状态下口服受试制剂洛索洛芬钠片（规格：60mg（以C15H17NaO3计），生产厂家：陕西盘龙药业集团股份有限公司）与参比制剂洛索洛芬钠片（规格：60mg（以C15H17NaO3计），持证商：第一三共制药（上海）有限公司）后在健康试验参与者体内的药代动力学行为，评价两种制剂的生物等效性。次要目的：观察洛索洛芬钠片受试制剂和参比制剂在中国健康试验参与者中的安全性。

[Translation]

Primary Objective: To evaluate the bioequivalence of the test formulation loxoprofen sodium tablets (60 mg (C15H17NaO3), manufactured by Shaanxi Panlong Pharmaceutical Group Co., Ltd.) and the reference formulation loxoprofen sodium tablets (60 mg (C15H17NaO3), licensee: Daiichi Sankyo Pharmaceutical (Shanghai) Co., Ltd.) in healthy participants after oral administration under fasting/postprandial conditions, using pharmacokinetic parameters as the primary endpoint. Secondary Objective: To observe the safety of the test and reference formulations of loxoprofen sodium tablets in healthy participants in China.

Start Date25 Jun 2026

Sponsor / Collaborator

Shaanxi Panlong Pharmaceutical Group Ltd. By Share Ltd.

NCT07591220

/ Not yet recruitingNot ApplicableIIT

The Efficacy and Safety of Incisional Preemptive Analgesia Using Loxoprofen Sodium Patch in Patients Undergoing Thoracoscopic Surgery: a Multi-center Randomized Controlled Trial.

Video-assisted thoracoscopic surgery (VATS) is less invasive compared to traditional thoracotomy, but it is still reported that the incidence of acute pain following VATS exceeds 80%. Inadequate postoperative analgesia may trigger a series of adverse physiological stress responses, increase the occurrence of postoperative complications, and affect the rehabilitation process. If acute pain is not managed promptly and sufficiently, nearly one-quarter of patients may develop chronic pain, impacting normal life and sleep quality after discharge. Acute pain after VATS is mainly caused by the release of inflammatory mediators after soft tissue injury at the surgical site, which activates peripheral pain receptors and leads to abnormal action potentials transmitted along A δ and C fibers. Inflammatory mediators released from the soft tissues around incisions not only significantly alters the chemical microenvironment at the peripheral terminals of nociceptors, directly inducing pain, but also sensitizes afferent fibers, contributing to peripheral sensitization. Therefore, drugs with potent local anti-inflammatory properties such as Loxoprofen Sodium may play a key role in preventing or reducing postoperative pain. The investigators conducted a multicenter, prospective, randomized controlled clinical study to explore the use of Loxoprofen Sodium Patch for preoperative local incision analgesia in VATS patients. The investigators aim to observe whether this method can effectively alleviate postoperative incision pain, reduce the dosage of postoperative analgesics and the side effects caused using postoperative analgesics, improve patient satisfaction, and provide new ideas for postoperative analgesia in VATS patients, promoting rapid recovery after VATS.

Start Date01 Jun 2026

Sponsor / Collaborator

Beijing Tiantan Hospital

100 Clinical Results associated with Loxoprofen Sodium Hydrate

100 Translational Medicine associated with Loxoprofen Sodium Hydrate

100 Patents (Medical) associated with Loxoprofen Sodium Hydrate

784

Literatures (Medical) associated with Loxoprofen Sodium Hydrate

01 Sep 2026·JOURNAL OF CONTROLLED RELEASE

Design of active pharmaceutical ingredient-ionic liquids for enhanced delivery to skin

Article

Author: Pérez-Cuevas, Mónica B ; Xu, Yuan ; Arslan Azizoglu, Gulcin ; Massey, Sarah ; Yang, Zhanhong ; Dani, Kunal ; Prausnitz, Mark R

Active pharmaceutical ingredient ionic liquids (API-ILs) can enhance skin delivery by tuning physicochemical properties based on ion-pair structure. We developed a four-step workflow to screen non-steroidal anti-inflammatory drug (NSAID)-based ion pairs formed by salt metathesis by (i) verifying IL formation using nuclear magnetic resonance spectroscopy, thermogravimetric analysis and differential scanning calorimetry; (ii) quantifying API-IL physicochemical properties relevant to skin transport, including drug concentration, molecular weight, aqueous solubility, and distribution coefficient; (iii) measuring API-IL skin permeation through pig skin ex vivo; and (iv) formulating API-ILs to reduce viscosity to further increase skin delivery. Of the screened ion pairs, 51% formed API-ILs, with ibuprofen and loxoprofen anions and benzethonium and triethylamine cations most associated with liquid formation. Relative to parent sodium salts, API-ILs exhibited higher drug concentration, higher molecular weight, generally lower aqueous solubility, and generally higher octanol-water distribution coefficient values. Balancing trade-offs between higher drug concentration (which increased skin delivery), higher molecular weight (which decreased skin delivery) and other factors, three of the API-ILs outperformed their parent salts, with more-than three-fold increased transdermal flux and 4-15 times greater intradermal delivery after viscosity reduction with ethanol. This integrated workflow identified API-ILs with improved skin delivery by tuning ion-pair properties, offering a path to rational API-IL design for topical and transdermal therapy.

01 Jul 2026·IN VIVO

Efficacy of Switching from Prior Nonsteroidal Anti-inflammatory Drugs to Transdermal Diclofenac in Cancer Pain Management

Article

Author: Mae, Yutaro ; Harashima, Wataru ; Yokokawa, Takashi ; Iikura, Yusuke ; Yamaguchi, Masakazu ; Ishiguro, Taizo ; Ochi, Mizuki ; Shimizu, Hisanori ; Hasegawa, Akiko ; Furutani, Ryota ; Kawakami, Kazuyoshi

BACKGROUND/AIM:

Nonsteroidal anti-inflammatory drugs (NSAIDs) are recommended for mild cancer pain and can be combined with opioids for moderate-to-severe pain. The efficacy of switching from prior NSAIDs to transdermal diclofenac in patients with cancer has not been fully evaluated, however.

PATIENTS AND METHODS:

We conducted a retrospective observational study at the Cancer Institute Hospital, Ariake, Japan, from May 21, 2021, to May 20, 2023. Hospitalized of patients with cancer who were switched from prior NSAIDs to transdermal diclofenac were included. Patients were excluded if they never applied the patch, could not continue treatment for ≥7 days, or had dementia/delirium precluding pain assessment. The primary endpoint was change in numerical rating scale (NRS) score from baseline (Day 0) to Day 8. Statistical analyses were performed using the Wilcoxon signed-rank test, with p<0.05 considered indicative of statistically significant differences.

RESULTS:

A total of 72 patients were included. The median age was 67 years, and 46 were female. Prior NSAIDs included loxoprofen, flurbiprofen, naproxen, and celecoxib. Concomitant opioids were used in 55 patients. Mean NRS score decreased from 3.8 to 2.4 by Day 8 (p<0.001). Forty-six patients (64%) showed reduced NRS scores. Rescue medication use decreased in 13 patients (18%), remained unchanged in 39 (54%), and increased in 20 (28%). One patient reported mild pruritus; no treatment discontinuation occurred.

CONCLUSION:

Switching to transdermal diclofenac effectively reduced pain in patients with cancer and may serve as a useful alternative when oral or prior NSAID therapy is difficult to continue.

01 Jun 2026·INJURY-INTERNATIONAL JOURNAL OF THE CARE OF THE INJURED

Lower dosing of Loxoprofen in type two diabetics with bone fractures/surgeries; Distinction from common NSAIDs

Article

Author: Badaineh, Batool ; Alomari, Yaser A ; Bustanji, Yasser K ; Hamdan, Mohammad Q ; Al-Rawashdeh, Hatem F ; Issa, Ala Y ; Al-Samarat, Firas ; AlAjlouni, Jihad M

AIM:

To investigate the appropriateness of lower doses of loxoprofen in patients with type two diabetes (T2D) with bone fractures/surgeries in comparison to common NSAIDs.

METHODS:

The current study is a prospective cross-sectional study. A total of 174 patients treated for bone fractures/orthopedic surgeries were recruited from orthopedic outpatient clinics in Amman, Madaba, and University of Jordan Hospital. Risk stratifications were performed for cardiovascular (CV), gastrointestinal (GI), renal, and hepatic complications. We created in-depth comparisons of safety and effectiveness of common NSAIDs in alleviating postoperative/ fracture pain.

RESULTS:

All NSAIDs showed variable reductions in the numerical pain score (NPS) after four weeks. Loxoprofen was the only NSAID prescribed at lower daily doses of 60-120 mg. Loxoprofen resulted in the most reduction in NPS; the fastest onset of action; the least time to reach peak analgesia; decrease in nocturia and the strongest overall pain relief in bone fractures and postoperative pain, p < 0.05. Celecoxib had the highest variability in pain relief among the agents.

CONCLUSION:

Lower doses of loxoprofen provide an effective strategy to alleviate postoperative and bone fracture pain and increase patient satisfactions among T2D at lower systemic risks compared to other NSAIDs. Such low dosing approach provides a plausible balanced triad of safety, effectiveness and maximum bone healing which lead to maximum patient satisfaction.

News (Medical) associated with Loxoprofen Sodium Hydrate

15 Apr 2026

·www.fiercepharma.com

In industry's latest OTC pivot, Daiichi Sankyo lines up $1.5B consumer health unit sale to beverage giant Suntory

Daiichi Sankyo Healthcare markets several popular over-the-counter treatments, such as the decades-old combination cold remedy Lulu and the anti-inflammatory pain and fever reducer Loxonin. With Daiichi Sankyo’s priorities increasingly tied to its innovative medicines—and its oncology portfolio in particular—the Tokyo-based drugmaker is following in the footsteps of several of its peers with a deal to split from its consumer health business. Daiichi has entered an agreement with Japanese beverage giant Suntory Holdings to transfer all shares in its subsidiary, Daiichi Sankyo Healthcare, which markets (PDF) a slate of popular over-the-counter treatments, including the decades-old combination cold remedy Lulu and the anti-inflammatory pain and fever reducer Loxonin. The current deal framework places the transfer value at 246.5 billion Japanese yen (roughly $1.55 billion), Daiichi Sankyo said in an April 15 press release (PDF). As it stands, Daiichi plans to carry out the transfer in stages, starting with the handover of 30% of its consumer health subsidiary’s shares this June. The entire process is expected to wrap up by June 2029, according to the company. Daiichi Sankyo currently holds 100% of the shares in the healthcare unit being sold to Suntory. In its release, Daiichi framed the deal as a means to ensure growth for its over-the-counter drugs business, which has also branched out into areas like skincare, oral care and food products. In turn, Daiichi said that moving forward, it would drill down on its innovative medicines business, and “particularly the oncology business.” Daiichi Sankyo has asserted itself in recent years as a force to be reckoned with among antibody-drug conjugate (ADC) developers, thanks to the success of its two AstraZeneca-partnered products, Enhertu and Datroway. Enhertu has been cleared across breast, gastric and non-small cell lung cancer (NSCLC), plus HER2-positive solid tumors, while Datroway—first approved early last year—is indicated for certain patients with breast cancer and NSCLC. At the J.P. Morgan Healthcare Conference earlier this year, Daiichi CEO Hiroyuki Okuzawa set out the ambition for his company’s ADCs to cover 700,000 eligible patients by fiscal year 2030—an impressive leap from the 120,000 the company tallied for its 2025 fiscal year, which ended in March. Apart from Daiichi, a growing number of drugmakers have elected to part ways with their over-the-counter businesses in recent years. Most recently, Sanofi scooped up 10 billion euros last spring by selling a controlling stake in its consumer health business Opella to U.S. private equity firm Clayton, Dubilier & Rice. Prior to that, prominent consumer health spinouts have been charted by Johnson & Johnson with its Kenvue business and GSK via Haleon, among multiple other recent examples.

Drug ApprovalADCAcquisition

15 Apr 2026

·firstwordpharma.com

Biopharma bites: Daiichi offloads consumer health, plus Alloy's raise and Replimune's layoffs

Daiichi sheds consumer health unit for $1.6BAlloy lands $40M in fundingReplimune downsizes after second FDA rebuffDaiichi sheds consumer health unit for $1.6BDaiichi Sankyo is offloading its consumer healthcare unit to Japanese beverage and consumer products giant Suntory Holdings for an expected price of JPN246.5 billion ($1.6 billion).The transaction, which will be carried out in stages, begins with a 30% stake transfer in June and concludes in mid-2029, ultimately making the business, known as Daiichi Sankyo Healthcare, a wholly owned unit of Suntory.The move reflects Daiichi's effort to concentrate resources on its core innovative medicines business, particularly oncology, where it has a strong presence in antibody-drug conjugates such as Enhertu (trastuzumab deruxtecan) and Datroway (datopotamab deruxtecan), both partnered with AstraZeneca. The divestment comes as former Novartis drug development head John Tsai settles into his new role as Daiichi's global R&D chief after joining earlier this month.Daiichi said Suntory's strength in consumer products makes it a more natural long-term fit for the unit, which sells products like over-the-counter analgesic Loxonin (loxoprofen sodium) and cold remedy Lulu in Japan, and has been expanding overseas.-Anna BratulicAlloy lands $40M in fundingAlloy Therapeutics closed a $40-million series E on Wednesday from investors including 8VC, JIC Venture Growth Investments and Echo Capital. The fundraising values the biotechnology ecosystem company at $1 billion.Proceeds will be used by Alloy to deepen its core discovery services for antibodies, genetic medicines and cell therapies, whilst also expanding its downstream preclinical and clinical development services. In addition, the firm will accelerate its AI and machine learning integration.Since its founding in 2017, Alloy's collaborations have led to over 100 licensed therapeutic programmes, 22 of which have advanced to clinical development, including two drugs in Phase III. The firm's most recent deal with Biogen is focused on using its AntiClastic antisense oligonucleotide platform to advance antisense therapeutics against multiple undisclosed targets. -Matt DennisReplimune downsizes after second FDA rebuffDays after US regulators rejected its melanoma therapy for a second time, Replimune disclosed it will cut 63 Massachusetts jobs, according to a state Worker Adjustment and Retraining Notification (WARN) filing. The layoffs are scheduled between April 13 and April 24 and will affect the company's Woburn operations.The workforce reduction follows a complete response letter last Friday denying accelerated approval of RP1 (vusolimogene oderparepvec), Replimune's oncolytic virus therapy for advanced melanoma in combination with Bristol Myers Squibb's Opdivo (nivolumab). Regulators again concluded that the supporting IGNYTE trial didn't constitute an adequate and well-controlled study, reiterating earlier concerns about the trial design and interpretability. It is the second rejection for RP1 after an initial denial in mid-2025.Replimune has defended RP1, citing a 34% response rate and durability of response in clinical data, while also criticising what it called a "slow-moving" review process and "inconsistent" FDA communication. After the setback, CEO Sushil Patel warned there would be job cuts, saying the company would have to "substantially" scale back US manufacturing and explore strategic alternatives.-Anna Bratulic

AcquisitionPhase 3

24 Sep 2025

·www.einpresswire.com

Huateng Pharma to Highlight PEG Derivatives and Key Pharmaceutical Intermediates at CPHI Frankfurt 2025

CHANGSHA, HUNAN, CHINA, September 24, 2025 / EINPresswire.com / -- Hunan Huateng Pharmaceutical Co., Ltd. (Huateng Pharma) is pleased to announce its participation at CPHI Frankfurt 2025, the premier global event for the pharmaceutical industry. The company will showcase its extensive product portfolio and advanced manufacturing capabilities at Booth 4.1H64. Visitors to the booth will be able to explore: PEG Derivatives: Huateng Pharma provides a wide range of PEG derivatives, including: Monodispersed PEGs: mPEG36-PEG, N3-PEG11-NH2, OH-PEG6-COOH. Polydisperse PEGs: mPEG-pALD, DSPE-PEG-Mannose, HZ-PEG-HZ. Multi-arm PEGs: Y-shape PEGs, 4-arm PEGs, 8-arm PEGs. More PEG derivatives>> These derivatives are applied in ADC linker design, PROTAC conjugation, PEGylation, dye labeling, and nanoparticle stabilization. Pharmaceutical Intermediates: Huateng Pharma also supplies key intermediates for late-stage clinical and marketed APIs, including: Aficamten Intermediate: 1-Methyl-1H-Pyrazole-4-Carboxylic Acid (CAS 5952-92-1). Voxelotor Intermediate: 1-Isopropyl-1H-pyrazole-5-boronic acid, pinacol ester (CAS 1282518-60-8). Loxoprofen Intermediate: 2-(4-Bromomethyl-phenyl)-propionic acid (CAS 111128-12-2). More intermediates>> Fine Chemicals: Specialty ingredients such as Diethylamino Hydroxybenzoyl Hexyl Benzoate (UVA filter, CAS 302776-68-7), Tetrahydrocurcumin (antioxidant, CAS 36062-04-1), and Piroctone Olamine (anti-fungal, CAS 68890-66-4), etc. Veterinary APIs: Including Fluralaner, Afoxolaner, and Atipamezole HCl. The company operates a 5,000 m² R&D center equipped with nearly 100 advanced analytical and testing instruments, including 400 MHz NMR, LC/MS, HPLC, and GC systems. Its 34,000 m² GMP-compliant plant includes four multifunctional production workshops, 100,000-grade dust-free clean rooms, and more than 800 advanced facilities such as enamel reactors, stainless steel hydrogenation reactors, and nitrogen production systems. By integrating DCS and SIS digital systems, Huateng Pharma enables real-time process monitoring and seamless scale-up from lab to pilot to commercial production. “We look forward to welcoming industry professionals to our booth at CPHI Frankfurt 2025. This event is an excellent opportunity to present our product lines and discuss how Huateng Pharma can support global drug development with high-quality, scalable solutions,” said Sonia Lee, Head of business development at Huateng Pharma. Huateng Pharma invites all attendees to visit Booth 4.1H64 to learn more and explore potential collaborations. About Huateng Pharma Hunan Huateng Pharmaceutical Co., Ltd. is a world-leading supplier of PEG derivatives, pharmaceutical intermediates, fine chemicals, and veterinary APIs. With a comprehensive R&D center and state-of-the-art GMP-compliant manufacturing facilities, Huateng Pharma provides reliable solutions from laboratory research to large-scale commercial production. The company is committed to supporting the global pharmaceutical and biotechnology industries with high-quality products and technical expertise. Contact: sales@huatengusa.com Website: https://us.huatengsci.com Sonia Lee Hunan Huateng Pharmaceutical Co., Ltd. sales@huatengusa.com Visit us on social media: LinkedIn Facebook X Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

100 Deals associated with Loxoprofen Sodium Hydrate

External Link

KEGG	Wiki	ATC	Drug Bank
D01709	Loxoprofen Sodium Hydrate	M01A	DB09212

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Pain, Postoperative	South Korea	Korea Prime Pharm Co., Ltd.	03 Apr 2024
Inflammation	Japan	Daiichi Sankyo Co., Ltd.	01 Mar 1986
Pain	Japan	Daiichi Sankyo Co., Ltd.	01 Mar 1986

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Post procedural inflammation	Phase 3	China	Guangzhou Aobo Medical Technology Co., Ltd.	25 Mar 2024
Post procedural inflammation	Phase 3	China	Guangdong Lewwin Pharmaceutical Research Institute Co.,Ltd.	25 Mar 2024
Arthropathy of knee joint	Phase 3	China	Chongqing Pharmaceutical Research Institute Co., Ltd.	10 Apr 2017
Osteoarthritis, Knee	Phase 3	China	Chongqing Pharmaceutical Research Institute Co., Ltd.	10 Apr 2017
Ocular inflammation	Phase 2	China	Guangzhou Aobo Medical Technology Co., Ltd.	30 Dec 2022
Ocular inflammation	Phase 2	China	Guangdong Lewwin Pharmaceutical Research Institute Co.,Ltd.	30 Dec 2022
Myalgia	Phase 2	United States	Lead Chemical Co., Ltd.	01 Oct 2015
Acute Bronchitis	Phase 1	China	Overseas Pharmaceuticals Ltd.	27 Dec 2024
Acute upper respiratory tract inflammation	Phase 1	China	Overseas Pharmaceuticals Ltd.	27 Dec 2024
Analgesia	Phase 1	China	Overseas Pharmaceuticals Ltd.	27 Dec 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05010707 (TREAT, CTgov)	Phase 2	-	39	Hormone Profile+Spironolactone+Transdermal patch (Transdermal Estradiol Plus Spironolactone)	gbsirjdsfg(diggkogqfg) = koljzcopmy rykjjhxuzx (fxrydjitln, 46.2) View more	-	26 Nov 2024
				Hormone Profile+Spironolactone+Daily Sublingual Tablet (Daily Sublingual Estradiol Plus Spironolactone)	gbsirjdsfg(diggkogqfg) = yuekpjylcr rykjjhxuzx (fxrydjitln, 61.3) View more
NCT02467504 (CTgov)	Phase 2	Rheumatoid Arthritis	47	Loxoprofen+Folic Acid+MTX+hrIL-2 active (Experimental)	inhowlxryv = nqqgepimxo jaxkjihlvd (rskjogarox, kncdzkfuuv - nzelukreiy) View more	-	09 Sep 2019
				hrIL-2 placebo+Loxoprofen+Folic Acid+MTX (Placebo Comparator)	inhowlxryv = qjolbmycmf jaxkjihlvd (rskjogarox, kwunwxcjrh - ygdzcbxaav) View more
NCT02831569 (CTgov)	Phase 3	Low Back Pain \| Trigeminal Neuralgia \| Periarthritis scapulohumeralis	80	Loxoprofen Sodium+Methocarbamol	immhpbkukj = kytwyshsio zytipkhdiq (mvlcrmcgom, fvebuygfgo - xvsthnyhfa) View more	-	20 Jul 2018
EULAR2016	Not Applicable	Ankylosing Spondylitis	70	Loxoprofen sodium hydrogel patch (LX-P)	vssynlault(lollorjhxk) = feybuiodsf zzapvcpzho (igtjwwfhcy )	Positive	08 Jun 2016
				Loxoprofen sodium tablet (LX-T)	vssynlault(lollorjhxk) = gyaznkvvrr zzapvcpzho (igtjwwfhcy )
NCT00994461 (Pubmed \| Aliment Pharmacol Ther)	Phase 4	First line	190	Celecoxib 100 mg b.d.	pyrtycoqxk(mvcyttedag) = ctwjxjipxp nitymucgsc (darkqhiobi )	Positive	01 Feb 2013
				Loxoprofen 60 mg t.d.s.	pyrtycoqxk(mvcyttedag) = qzoavoebye nitymucgsc (darkqhiobi )

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