Last update 21 Nov 2024

Norfloxacin

Last update 21 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

1,4-Dihydro-1-ethyl-6-fluoro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid, 1-Ethyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid, NFLX

+ [28]

Target

Bacterial DNA gyrase

Mechanism

Bacterial DNA gyrase inhibitors

Therapeutic Areas

Infectious DiseasesEye DiseasesUrogenital Diseases+ [1]

Active Indication

Corneal UlcerBlepharitisConjunctivitis+ [7]

Inactive Indication

Cystitis

Originator Organization

KYORIN Pharmaceutical Co., Ltd.

Active Organization

KYORIN Pharmaceutical Co., Ltd.Central Pharmaceutical JSC No. 3

Nichi-Iko Pharmaceutical Co., Ltd.

Inactive Organization

Merck Research Laboratories Massachusetts LLC

Eurofarma Laboratórios SA

Drug Highest PhaseApproved

First Approval Date

CN (01 Jan 1986),

GonorrheaProstatitisTyphoid Fever+ [1]

Regulation-

Structure

Molecular FormulaC16H18FN3O3

InChIKeyOGJPXUAPXNRGGI-UHFFFAOYSA-N

CAS Registry70458-96-7

Clinical Trials associated with Norfloxacin

CTR20241157 / CompletedNot Applicable

诺氟沙星胶囊（0.1g）在中国健康受试者中空腹给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of norfloxacin capsules (0.1 g) in Chinese healthy volunteers under fasting conditions

主要研究目的：按有关生物等效性试验的规定，选择杏林制药株式会社为持证商的诺氟沙星片（商品名：BACCIDAL®，规格：100mg/片）为参比制剂，对哈药集团制药六厂生产、哈药集团制药总厂提供的受试制剂诺氟沙星胶囊（规格：0.1g/粒）进行空腹给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评估两种制剂在空腹给药条件下的生物等效性。次要研究目的：观察健康志愿受试者口服受试制剂诺氟沙星胶囊（规格：0.1g/粒）和参比制剂诺氟沙星片（商品名：BACCIDAL®，规格：100mg/片）的安全性。

[Translation]

Main research purpose: According to the relevant provisions of bioequivalence test, the norfloxacin tablets (trade name: BACCIDAL®, specification: 100mg/tablet) of which Xinglin Pharmaceutical Co., Ltd. is the licensee was selected as the reference preparation, and the test preparation norfloxacin capsules (specification: 0.1g/tablet) produced by Harbin Pharmaceutical Group Pharmaceutical Factory No. 6 and provided by Harbin Pharmaceutical Group Pharmaceutical Factory were tested for human bioequivalence under fasting administration. The absorption rate and degree of the drug in the test preparation were compared with those of the reference preparation to see if they were within an acceptable range, and the bioequivalence of the two preparations under fasting administration conditions was evaluated. Secondary research purpose: To observe the safety of oral administration of the test preparation norfloxacin capsules (specification: 0.1g/tablet) and the reference preparation norfloxacin tablets (trade name: BACCIDAL®, specification: 100mg/tablet) by healthy volunteers.

Start Date15 Apr 2024

Sponsor / Collaborator

Harbin Pharmaceutical Group Co. Ltd. General Pharm Factory

CTR20240282 / CompletedNot Applicable

诺氟沙星胶囊在健康受试者中单中心、随机、开放、两制剂、单次给药、两周期、双交叉空腹生物等效性试验研究方案

[Translation] Study plan for a single-center, randomized, open-label, two-formulation, single-dose, two-period, double-crossover fasting bioequivalence trial of norfloxacin capsules in healthy subjects

主要目的：以药代动力学参数作为主要终点评价指标，比较在空腹状态下口服受试制剂诺氟沙星胶囊（规格：0.1g，持证商：广东恒健制药有限公司）与参比制剂诺氟沙星片（规格：0.1g，持证商：杏林制药株式会社，商品名：BACCIDAL®）后在健康受试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：观察受试制剂诺氟沙星胶囊和参比制剂诺氟沙星片在健康受试者中的安全性。

[Translation]

Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation index, compare the pharmacokinetic behavior of the test preparation norfloxacin capsule (specification: 0.1g, license holder: Guangdong Hengjian Pharmaceutical Co., Ltd.) and the reference preparation norfloxacin tablet (specification: 0.1g, license holder: Xinglin Pharmaceutical Co., Ltd., trade name: BACCIDAL®) in healthy subjects after oral administration in the fasting state, and evaluate the bioequivalence of the two preparations. Secondary purpose: Observe the safety of the test preparation norfloxacin capsule and the reference preparation norfloxacin tablet in healthy subjects.

Start Date03 Mar 2024

Sponsor / Collaborator

Jiangmen Hengjian Pharmaceutical Co. Ltd.

CTR20230089 / CompletedNot Applicable

诺氟沙星胶囊在健康受试者中空腹状态下的单中心、随机、开放、两制剂、单剂量、双周期、两序列、双交叉生物等效性试验研究方案

[Translation] A single-center, randomized, open-label, two-formulation, single-dose, two-period, two-sequence, double-crossover bioequivalence study protocol for norfloxacin capsules in healthy subjects under fasting condition

主要目的：以药代动力学参数作为主要终点评价指标，比较在空腹状态下口服受试制剂诺氟沙星胶囊（生产厂家：武汉同济现代医药科技股份有限公司）与参比制剂诺氟沙星片（持证商：杏林制药株式会社，商品名：BACCIDAL®）后在健康受试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：观察受试制剂诺氟沙星胶囊和参比制剂诺氟沙星片在健康受试者中的安全性。

[Translation]

Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation index, compare the pharmacokinetic behavior of the test preparation norfloxacin capsules (manufacturer: Wuhan Tongji Modern Pharmaceutical Technology Co., Ltd.) and the reference preparation norfloxacin tablets (licensed manufacturer: Xinglin Pharmaceutical Co., Ltd., trade name: BACCIDAL®) in healthy subjects after oral administration in the fasting state, and evaluate the bioequivalence of the two preparations. Secondary purpose: Observe the safety of the test preparation norfloxacin capsules and the reference preparation norfloxacin tablets in healthy subjects.

Start Date22 Feb 2023

Sponsor / Collaborator

Wuhan Tongji Modern Pharmaceutical Technology Co., Ltd.

100 Clinical Results associated with Norfloxacin

100 Translational Medicine associated with Norfloxacin

100 Patents (Medical) associated with Norfloxacin

5,717

Literatures (Medical) associated with Norfloxacin

01 Feb 2025·Journal of Colloid and Interface Science

Specific smart sensing of electron-rich antibiotics or histidine improves the antenna effect, luminescence, and photodynamic sterilization capabilities of lanthanide polyoxometalates

Article

Author: Li, Yun-Lan ; Tang, Meng-Juan ; Qin, Wen-Wen ; Wang, Hai-Ling ; Zhu, Zhong-Hong ; Zou, Hua-Hong ; Liang, Fu-Pei

Excessive discharge of antibiotics seriously threatens human health and is thus a global public health problem. This highlights the urgent need to develop intelligent sensing materials for specific antibiotics that are highly visual, fast, convenient, and inexpensive. Herein, two reverse α-octamolybdate polyoxometalates (POMs; Mo₈) were used to chelate lanthanide ions to obtain lanthanide POMs (LnPOMs; LnMo₁₆; Ln = Eu, Sm, Tb, Gd) with highly sensitive smart photoresponses to specific antibiotics (ofloxacin [OFN], norfloxacin [NOR], enrofloxacin [ENR], and oxytetracycline [OTC]) and histidine (His) with luminescence turn-on. Specific antibiotics and His, which has an electron-rich structure, can efficiently enhance the antenna effect, thereby greatly improving the luminescence of EuMo₁₆. Surprisingly, OFN and NOR both enhanced the luminescence of Eu(III) ions and Mo₈, whereas ENR and OTC only enhanced the luminescence of Eu(III) ions, showing a differentiated sensitization effect. More notably, the combination of POMs and Ln(III) ions enhanced the ability of LnPOMs to produce reactive oxygen species under light irradiation, and these LnPOMs showed significant sterilization effects on Escherichia coli and Staphylococcus aureus. To our knowledge, this is the first time electron-rich antibiotics or amino acids were used to enhance the luminescence of LnPOMs, achieving luminescence-enhanced photoresponse to specific antibiotics and amino acids.

01 Feb 2025·Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy

Lithium-doped ZrO2 nanoparticles for SERS-based norfloxacin drug detection

Article

Author: Mao, Zhu ; Yi, Mingyue ; Xu, Jiawen ; Shi, Xiumin ; Jung, Young Mee ; Yang, Bo ; Chi, Yanze

Surface-enhanced Raman scattering (SERS) spectroscopy is a highly specific and ultrasensitive analytical technique; thus, it is an ideal candidate for therapeutic drug monitoring. However, SERS measurements of drugs in a sample are inevitably affected by the environment. In this study, we synthesized ZrO₂ nanoparticles (NPs) doped with the first group of elements (Li, Na, and K) in the main block and evaluated their SERS performance. The results showed that Li-ion doping could significantly enhance the SERS effect, and the degree of enhancement depended on the type and concentration of the doped ions. Compared with the highly stable ZrO₂, Li ion-doped ZrO₂ (Li-ZrO₂) exhibited a significant increase in SERS activity. In particular, 1 % Li-ZrO₂ NPs exhibited excellent SERS enhancement with an enhancement factor (EF) of 2.60 × 10⁴, which was attributed to the decreased band gap and improved the charge transfer (CT) process after Li ion doping. The adsorption capacity of the Li-ZrO₂ NPs for norfloxacin (NOR) molecules was gradually saturated with time. In addition, both acidic and alkaline conditions were unfavorable for NOR detection by the substrate. The SERS intensity exhibited a linear relationship within the NOR concentration range of 10^-3-10^-6 mol/L, and approximately 97.51 % of the active ingredients were detected, with a competitive detection limit of 10^-⁶ mol/L. Furthermore, NOR detection is cost-effective and time-efficient, and the results of our study can aid in the research process and support practical applications. The proposed study provides a guidance for improving the SERS activity of semiconductors for sensing.

01 Jan 2025·Water Research

Photothermal nano-confinement reactor with bimetallic sites for enhanced peroxymonosulfate activation in antibiotic degradation

Article

Author: Li, Renjie ; Shen, Liguo ; Wu, Xi-Lin ; Cao, Yuzhen ; Wang, Hao ; Lin, Hongjun ; Li, Bisheng

In recent years, photothermal-assisted Fenton-like degradation of organic pollutants has become a prominent green method in environmental pollution control. Nevertheless, the design of suitable catalysts remains a significant challenge for this approach. Herein, zeolite-imidazolate framework-derived CoMn bimetallic nanoparticles embedded in hollow carbon nanofibers (CoMnHCF) have been developed as a photothermal nano-confinement reactor with multiple active sites to enhance reaction performance and promote peroxymonosulfate (PMS) activation. Under light irradiation, the local temperature within the porous spaces of CoMnHCF was significantly higher than the liquid temperature. The confined space concentrated heat, minimized thermal loss, and effectively utilizes this feature to activate PMS for antibiotic degradation. The results demonstrated that this system efficiently degraded various antibiotics, including tetracycline hydrochloride, levofloxacin, sulfamethoxazole, norfloxacin and chlorotetracycline. Photothermal contribution analysis revealed that thermal effects predominate in this system. Further DFT simulations explored the coordination environment of metal elements and the properties of related pollutants, predicting potential structures and reaction sites. A series of water quality experiments and cyclic tests demonstrated the system's significant application potential. This study offered new insights into advancing the integrated use of photothermal conversion and nano-confinement reactor activation of PMS in sewage purification.

News (Medical) associated with Norfloxacin

09 Feb 2021

·www.globenewswire.com

Global Urinary Tract Infection Treatment Markets, 2020-2027 - Market for Penicillin and Combination Drugs Segment to Grow at Highest Rate

Dublin, Feb. 09, 2021 (GLOBE NEWSWIRE) -- The "Urinary Tract Infection Treatment Market Forecast to 2027 - COVID-19 Impact and Global Analysis By Drug Class, Indication, Distribution Channel, and Geography" report has been added to ResearchAndMarkets.com's offering. Market for Penicillin and Combination Drugs Segment to Grow at Highest CAGR during 2020-2027. The market is expected to reach US$ 11,614.32 million by 2027 from US$ 9,106.40 million in 2019; it is estimated to grow at a CAGR of 3.2% from 2020 to 2027. The growth of the market is attributed to the growing prevalence of urinary tract infections, aging population, and emerging computing technologies for urine diagnostics. However, the lack of product awareness in emerging countries and effects associated with medication obstruct the growth of the market to a certain extent. Based on drug class, the quinolones segment held the largest share of the market in 2019; however, the penicillin and combination segment is anticipated to register the highest CAGR of 4.5% in the market during the forecast period. The future growth of the market for quinolones is mainly ascribed to the fact that it is most commonly prescribed by physicians. Ciprofloxacin, levofloxacin, and enoxacin are among the most widely used drugs for treatment. R& D in UTI treatment is expected to offer lucrative growth opportunities to the players in the global urinary tract infection treatment market. For instance, in July 2018, Lupin received approval from the US Food and Drug Administration (FDA) for generic Nitrofurantoin capsules. It is a generic version of Macrodantin offered by Alvogen Malta Operations Ltd. It is used to treat UTI caused by Staphylococcus aureus, enterococci, etc. Further, in February 2020, a France-based pharmaceutical company announced Exblifep, a combination of a novel extended-spectrum beta-lactamase inhibitor, enmetazobactam, and cefepime. i.e., the fourth-generation cephalosporin, which achieved primary endpoints in a clinical trial for complicated UTIs. Moreover, in July 2019, Healthy.io, a smartphone camera-based solutions developer, announced an agreement with Walgreens Boots Alliance, Inc. placing Healthy.io's Dip UTI test kits in boots pharmacies throughout the UK. Additionally, in May 2020, Spero Therapeutics, Inc. announced the completion of patient enrollment in its Phase 3 clinical trial, ADAPT-PO, of tebipenem HBr to treat complicated urinary tract infection (cUTI) and acute pyelonephritis (AP). In July 2019, the US FDA approved Recarbrio drug to treat cUTI and complicated intra-abdominal infection in adults. In June 2018, Achaogen, Inc. received the US FDA approval for ZEMDRI to treat cUTIs in adults. In November 2018, Allergan, announced the launch of the FDA accepted supplemental drug AVYCAZ to treat cUTIs and complicated intra-abdominal infections patients between the age group of 3 months to 18 years. Applying such strategic measures can be lucrative for the urinary tract infection treatment market during the forecast period. Teva Pharmaceutical Industries Ltd, Sun Pharmaceutical Industries Ltd, Mylan N.V., ALLERGAN, Pfizer Inc., Cipla Ltd, F. Hoffmann-La Roche Ltd, Shionogi Inc., Amway, and DuPont Nutrition & Biosciences are among the leading companies in the urinary tract infection treatment market. Key Topics Covered: 1. Introduction 2. Urinary Tract Infection Treatment Market - Key Takeaways 3. Research Methodology 3.1 Coverage 3.2 Secondary Research 3.3 Primary Research 4. Urinary Tract Infection Treatment Market - Market Landscape 4.1 Overview 4.2 PEST Analysis 4.3 Expert Opinion 5. Urinary Tract Infection Treatment Market - Key Market Dynamics 5.1 Market Drivers 5.1.1 Growing Urinary Tract Infections 5.1.2 Aging Population 5.1.3 Emerging Computing Technologies for Urine Diagnostics 5.2 Market Restraints 5.2.1 Associated Effects of Medication 5.3 Market Opportunities 5.3.1 R&D in UTI Treatment 5.4 Future Trends 5.4.1 Nutritional Supplement in UTI 6. Urinary Tract Infection Treatment Market - Global Analysis 6.1 Global Urinary Tract Infection Treatment Market Revenue Forecast and Analysis 6.2 Global Urinary Tract Infection Treatment Market, By Geography - Forecast and Analysis 6.3 Market Positioning of Key Players 7. Urinary Tract Infection Treatment Market Analysis - By Drug Class 7.1 Overview 7.2 Urinary Tract Infection Treatment Market Revenue Share, by Drug Class (2019 and 2027) 7.3 Penicillin and Combinations 7.3.1 Overview 7.3.2 Penicillin and Combinations: Urinary Tract Infection Treatment Market - Revenue and Forecast to 2027 (US$ Million) 7.3.3 Amoxicillin 7.3.4 Amoxicillin and Clavulanate Potassium 7.4 Quinolones 7.4.1 Overview 7.4.2 Quinolones: Urinary Tract Infection Treatment Market - Revenue and Forecast to 2027 (US$ Million) 7.4.3 Ciprofloxaxin 7.4.4 Levofloxaxin 7.4.5 Nalidixic Acid 7.4.6 Norfloxacin 7.4.7 Others 7.5 Cephalosporin 7.6 Aminoglycoside Antibiotics 7.7 Sulphonamides 7.8 Nutritional Supplements 7.8.1 Overview 7.8.2 Nutritional Supplements: Urinary Tract Infection Treatment Market - Revenue and Forecast to 2027 (US$ Million) 7.8.3 Cranberry Supplements 7.8.4 D-Mannose 7.8.5 Probiotics 7.8.6 Vitamin-C 8. Urinary Tract Infection Treatment Market Analysis - By Indication 8.1 Overview 8.2 Urinary Tract Infection Treatment Market Revenue Share, by Indication (2019 and 2027) 8.3 Complicated Urinary Tract Infections 8.4 Uncomplicated Urinary Tract Infections 9. Urinary Tract Infection Treatment Market Analysis - By Distribution Channel 9.1 Overview 9.2 Urinary Tract Infection Treatment Market Revenue Share, by Distribution Channel (2019 and 2027) 9.3 Hospital Pharmacies 9.4 Retail Pharmacies & Drug Stores 9.5 Gynaecology and Urology Clinics 9.6 Online Drug Stores 10. Urinary Tract Infection Treatment Market - Geographic Analysis 11. Impact of COVID-19 Pandemic on Global Urinary Tract Infection Treatment Market 12. Urinary Tract Infection Treatment Market-Industry Landscape Companies Mentioned Teva Pharmaceutical Industries Ltd Sun Pharmaceutical Industries Ltd Mylan N.V. ALLERGAN Pfizer Inc. Cipla Ltd F. Hoffmann-La Roche Ltd Shionogi Inc. Amway DuPont Nutrition & Biosciences For more information about this report visit CONTACT: ResearchAndMarkets.com Laura Wood, Senior Press Manager press@researchandmarkets.com For E.S.T Office Hours Call 1-917-300-0470 For U.S./CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900

Collaborate

100 Deals associated with Norfloxacin

External Link

KEGG	Wiki	ATC	Drug Bank
D00210	Norfloxacin	J01MA06 S01AE02	DB01059

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Corneal Ulcer	JP	KYORIN Pharmaceutical Co., Ltd.	24 Nov 1992
Blepharitis	JP	Nichi-Iko Pharmaceutical Co., Ltd.	30 Jun 1989
Blepharitis	JP	KYORIN Pharmaceutical Co., Ltd.	30 Jun 1989
Conjunctivitis	JP	KYORIN Pharmaceutical Co., Ltd.	30 Jun 1989
Dacryocystitis	JP	Nichi-Iko Pharmaceutical Co., Ltd.	30 Jun 1989
Dacryocystitis	JP	KYORIN Pharmaceutical Co., Ltd.	30 Jun 1989
Hordeolum	JP	KYORIN Pharmaceutical Co., Ltd.	30 Jun 1989
Hordeolum	JP	Nichi-Iko Pharmaceutical Co., Ltd.	30 Jun 1989
Keratitis	JP	Nichi-Iko Pharmaceutical Co., Ltd.	30 Jun 1989
Gonorrhea	CN	Central Pharmaceutical JSC No. 3	01 Jan 1986
Prostatitis	CN	Central Pharmaceutical JSC No. 3	01 Jan 1986
Typhoid Fever	CN	Central Pharmaceutical JSC No. 3	01 Jan 1986
Urinary Tract Infections	CN	Central Pharmaceutical JSC No. 3	01 Jan 1986

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Cystitis	Phase 3	-	Eurofarma Laboratórios SA	01 Oct 2012

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03584724 (CTgov)	Early Phase 1	Uveitis	49	Norflo Oro (Norflo Oro)	ukixvpdjfc(uyufmbmxee) = jrbuhhujrp ucetootwzu (tzilnshiod, aksjmdecmr - ixhmbhjspw) View more	-	28 Mar 2022
				Placebo for Norflo Oro (Placebo for Norflo Oro)	ukixvpdjfc(uyufmbmxee) = coqffrsplb ucetootwzu (tzilnshiod, xdgoempave - lixufkwcpo) View more
NCT03695705 (Pubmed)	Phase 3	Spontaneous bacterial peritonitis	132	Rifaximin	gyqpfttnki(qerxvjvixm) = uzmmsixkqo rmgldjrdjz (rxgqbxfnvd ) View more	-	01 Mar 2022
				Norfloxacin	gyqpfttnki(qerxvjvixm) = zleclxrjbq rmgldjrdjz (rxgqbxfnvd ) View more
EASL2020	Not Applicable	Spontaneous bacterial peritonitis	1,626	Norfloxacin	awcmmjpltj(rovyldmkse) = rakjfrfilb phckyjurdq (euknshiqzg ) View more	Negative	27 Aug 2020
				Placebo	-
NCT04159870 (Pubmed \| Curr Drug Targets)	Phase 3	Spontaneous bacterial peritonitis	973	Rifaximin plus norfloxacinRifaximin plus norfloxacin	(mlpkdvjcmc): RR = 0.58 (95% CI, 0.37 - 0.92), P-Value = 0.02 View more	Positive	01 Jan 2019
				Norfloxacin-based regimen
NCT01037959 (Pubmed \| J Laparoendosc Adv Surg Tech A)	Phase 3	Fibrosis	291	Norfloxacin 400 mg	(idjokkikjt) = bfszjdcnxr akgriinsps (zeovkemonu )	-	01 Dec 2018
				Placebo	(idjokkikjt) = sqjyrelhce akgriinsps (zeovkemonu )
PA031 (AAO2003)	Not Applicable	-	206	Levofloxacin	wemstbcsno(buyddazyrv) = qxdanwxcyf qxqpnebmzj (gqnvrqalcm )	Positive	17 Nov 2003
				Norfloxacin	wemstbcsno(buyddazyrv) = pdkbozncly qxqpnebmzj (gqnvrqalcm )
ARVO2002	Not Applicable	-	-	Levofloxacin 0.5%	(tafwnuiwst) = kdamtvpcqs kuaoejqazn (pxztgcblmr, 3.53)	-	01 Dec 2002
				Norfloxacin 0.3%	(tafwnuiwst) = jtduihfiqh kuaoejqazn (pxztgcblmr, 1.18)
NCT04159870 (Pubmed \| J Laparoendosc Adv Surg Tech A)	Phase 3	Gastrointestinal Hemorrhage	119	Norfloxacin	zexpsjjfqs(tcccvskskt) = ybpjccdkwf fqdmezpgsc (duxlujqysk ) View more	-	01 Oct 1992
				Norfloxacin (Control)	(kxyhaexhhr) = ildqoffyty fbwpbivvyp (cfjjdwwcti ) View more

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