Last update 21 Nov 2024

Cefdinir

Last update 21 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryCefdinir, marketed under the brand name Omnicef, is a small molecule drug that acts as a penicillin-binding protein (PBP) inhibitor and a cell wall inhibitor. It is indicated for the treatment and prevention of infections caused by susceptible bacteria. Cefdinir works by inhibiting the growth and multiplication of bacteria that cause infections, including streptococcus, staphylococcus, and Haemophilus influenzae. It is approved in several countries, including the US, China, Japan, and South Korea. Omnicef is available as capsules or an oral suspension and is typically administered once or twice daily depending on the severity of the infection. It is important to use this medication only for the treatment or prevention of bacterial infections, as overuse or misuse can lead to the development of drug-resistant bacteria.

Drug Type

Small molecule drug

Synonyms

CFDN, Cefdinir (JP17/USP/INN), Cefzon Capsule

+ [19]

Target

PBPs

Mechanism

PBPs inhibitors(Bacterial penicillin-binding protein inhibitors), Cell wall inhibitors

Therapeutic Areas

Infectious DiseasesMouth and Tooth DiseasesOtorhinolaryngologic Diseases+ [3]

Active Indication

BronchitisCystitisOtitis Media+ [8]

Inactive Indication

Acute BronchitisAcute maxillary sinusitisAcute otitis media+ [24]

Originator Organization

Astellas Pharma, Inc.

Active Organization

LTL Pharma Co., Ltd.

Pfizer Inc.

Astellas Pharma, Inc.

+ [3]

Inactive Organization

Abbott Laboratories

Shenzhen Zhijun Pharmaceutical Trade Co., Ltd.

AbbVie, Inc.

Drug Highest PhaseApproved

First Approval Date

(01 Jan 1991),

Gram-Negative Bacterial InfectionsGram-Positive Bacterial Infections

RegulationPriority Review (CN)

Structure

Molecular FormulaC14H13N5O5S2

InChIKeyRTXOFQZKPXMALH-GHXIOONMSA-N

CAS Registry91832-40-5

Clinical Trials associated with Cefdinir

CTR20243582 / CompletedNot Applicable

中国健康受试者空腹和餐后口服STBN的随机、开放、两序列、两周期、双交叉设计的生物等效性试验

[Translation] A randomized, open-label, two-sequence, two-period, double-crossover bioequivalence study of fasting and fed oral administration of STBN in healthy Chinese subjects

主要研究目的研究空腹和餐后状态下单次口服受试制剂头孢地尼干混悬剂（规格：250mg/5ml，广东万泰科创药业有限公司提供）与参比制剂头孢地尼干混悬剂（规格：250mg/5ml，持证商：Aurobindo Pharma Limited），在健康成年受试者体内的药代动力学，评价空腹和餐后口服两种制剂的生物等效性。次要研究目的评价中国健康受试者空腹和餐后状态下，单次口服受试制剂头孢地尼干混悬剂和参比制剂头孢地尼干混悬剂后的安全性。

[Translation]

Main study objectives To study the pharmacokinetics of the test preparation cefdinir dry suspension (specification: 250mg/5ml, provided by Guangdong Wantai Kechuang Pharmaceutical Co., Ltd.) and the reference preparation cefdinir dry suspension (specification: 250mg/5ml, licensee: Aurobindo Pharma Limited) in healthy adult subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations after fasting and fed oral administration. Secondary study objectives To evaluate the safety of the test preparation cefdinir dry suspension and the reference preparation cefdinir dry suspension after a single oral administration in the fasting and fed state in healthy Chinese subjects.

Start Date29 Sep 2024

Sponsor / Collaborator

Guang Dong Wan Tai Ke Chuang Yao Ye You Xian Gong Si

CTR20242859 / CompletedNot Applicable

头孢地尼干混悬剂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/餐后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/fed bioequivalence trial of cefdinir dry suspension 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，分别比较在空腹/餐后状态下口服受试制剂头孢地尼干混悬剂（生产厂家：苏州第三制药厂有限责任公司）与参比制剂头孢地尼干混悬剂（持证商：Aurobindo Pharma Limited）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。

[Translation]

Main objective: To compare the pharmacokinetic parameters as the primary endpoint evaluation indicators, the pharmacokinetic behavior of the test preparation cefdinir dry suspension (manufacturer: Suzhou Third Pharmaceutical Factory Co., Ltd.) and the reference preparation cefdinir dry suspension (licensed manufacturer: Aurobindo Pharma Limited) in healthy subjects after oral administration in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations.

Start Date10 Sep 2024

Sponsor / Collaborator

Suzhou No.3 Pharmaceutical Factory Co., Ltd.

CTRI/2024/08/072824 / Not yet recruitingPhase 4IIT

Comparative evaluation of Cefdinir and Amoxicillin with Clavulanic acid in cases of Acute otitis media in adult population- A randomized control trial - NIL

Start Date30 Aug 2024

Sponsor / Collaborator-

100 Clinical Results associated with Cefdinir

100 Translational Medicine associated with Cefdinir

100 Patents (Medical) associated with Cefdinir

497

Literatures (Medical) associated with Cefdinir

01 Dec 2024·International Journal of Pharmaceutics

Formulation and optimization of surfactant-modified chitosan nanoparticles loaded with cefdinir for novel topical drug delivery: Elevating wound healing efficacy with enhanced antibacterial properties

Article

Author: Badawi, Noha M ; Badawi, Noha M. ; Teaima, Mahmoud H. ; Badie, Merna A ; El-Nabarawi, Mohamed A ; El-Nabarawi, Mohamed A. ; Badie, Merna A. ; Teaima, Mahmoud H

Burn wounds remain a significant global health concern, frequently exacerbated by bacterial infections that hinder healing and raise morbidity rates. Cefdinir, a third-generation cephalosporin antibiotic, is used to treat various conditions, but it has limitations such as low water solubility, limited bioavailability, and a short biological half-life. This study aimed to fabricate and optimize novel surfactant-based Cefdinir-loaded chitosan nanoparticles (CFD-CSNPs) for enhancing topical CFD delivery and efficacy in burn healing. Box-Behnken Design (BBD) was employed to develop optimized CFD-CSNPs using Design Expert® software, where the independent factors were chitosan concentration, chitosan: sodium tripolyphosphate ratio, pH, and surfactant type. Particle size PS, zeta potential ZP, Polydispersity index PDI, and entrapment efficiency EE% were evaluated as dependent factors. CFD-CSNPs were produced using the ionic gelation method. The optimized formula was determined and then examined for further in vitro and in vivo assessments. The optimized CFD-CSNPs exhibited acceptable PS, PDI, and ZP values. The EE% of CFD from CSNPs reached 57.89 % ± 1.66. TEM analysis revealed spherical morphology. In vitro release studies demonstrated a biphasic release profile up to (75.5 % ± 3.8) over 48 hrs. The optimized CFD-CSNPs showed improved antimicrobial efficacy against the tested microorganisms, exhibiting superior performance for both biofilm prevention and eradication. Enhanced wound healing activity was achieved by the optimized CFD-CSNPs in both in vitro and in vivo studies as confirmed by scratch wound assay and skin burn mice model. The current study advocates the efficacy of the innovative topical application of CFD-CSNPs for wound healing purposes and treatment of wound infections.

03 Oct 2024·Journal of Applied Microbiology

Synergistic oral beta-lactam combinations for treating tuberculosis

Article

Author: Martinez, Elena ; Sintchenko, Vitali ; Kim, Hannah Y ; Alffenaar, Jan-Willem C ; Triccas, James A ; Wang, Trixie ; Britton, Warwick J ; Quan, Diana H

AbstractBackgroundThe enormous burden of tuberculosis (TB) worldwide is a major challenge to human health, but the costs and risks associated with novel drug discovery have limited treatment options for patients. Repurposing existing antimicrobial drugs offers a promising avenue to expand TB treatment possibilities. This study aimed to explore the activity and synergy of beta-lactams in combination with a beta-lactamase inhibitor, which have been underutilized in TB treatment to date.MethodsBased on inhibitory concentration, oral bioavailability, and commercial availability, seven beta-lactams (cefadroxil, tebipenem, cephradine, cephalexin, cefdinir, penicillin V, and flucloxacillin), two beta-lactamase inhibitors (avibactam and clavulanate), and three second-line TB drugs (moxifloxacin, levofloxacin, and linezolid) were selected for combination in vitro testing against Mycobacterium tuberculosis H37Rv. Resazurin assays and colony forming unit enumeration were used to quantify drug efficacy, Chou-Talalay calculations were performed to identify drug synergy and Chou-Martin calculations were performed to quantify drug dose reduction index.ResultsThe order of activity of beta-lactams was cefadroxil > tebipenem > cephradine > cephalexin > cefdinir > penicillin V > flucloxacillin. The addition of clavulanate improved beta-lactam activity to a greater degree than the addition of avibactam. As a result, avibactam was excluded from further investigations, which focused on clavulanate. Synergy was demonstrated for cefdinir/cephradine, cefadroxil/tebipenem, cefadroxil/penicillin V, cefadroxil/cefdinir, cephalexin/tebipenem, cephalexin/penicillin V, cephalexin/cefdinir, cephalexin/cephradine, and cefadroxil/cephalexin, all with clavulanate. However, combining beta-lactams with moxifloxacin, levofloxacin, or linezolid resulted in antagonistic effects, except for the combinations of penicillin V/levofloxacin, penicillin V/moxifloxacin, and cefdinir/moxifloxacin.ConclusionsBeta-lactam synergy may provide viable combination therapies for the treatment of TB.

01 Oct 2024·Journal of Chromatographic Science

Correction to: Solid-Phase Extraction (SPE) Technique to Quantify Cefdinir in Human Plasma Using Liquid Chromatography–Tandem Mass Spectrometry (LC–MS/MS)

News (Medical) associated with Cefdinir

28 Aug 2023

·www.globenewswire.com

Elicio Therapeutics Announces Appointment of Megan Filoon as General Counsel and Dr. Thian Kheoh as Senior Vice President of Biometrics

BOSTON, Aug. 28, 2023 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (Nasdaq: ELTX), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today announced the appointment of Megan Filoon as General Counsel and Dr. Thian Kheoh as Senior Vice President of Biometrics. Ms. Filoon will oversee all company legal affairs including corporate governance and compliance functions. Dr. Kheoh will provide biostatistical leadership and strategic guidance into the development of the Company’s product candidate portfolio including the ongoing AMPLIFY-201 and AMPLIFY-7P trials of the lead asset, ELI-002. “Megan and Thian are joining us at an exciting time following our recent transition to a public company and as we continue to advance our lead clinical cancer vaccine candidate, ELI-002, for patients with mKRAS-driven cancers,” said Robert Connelly, Chief Executive Officer at Elicio Therapeutics. “Megan and Thian further strengthen an outstanding leadership team and their expertise will be invaluable in strengthening our legal and compliance functions, and processing data from our AMPLIFY trials, respectively.” Megan Filoon most recently served as the General Counsel and Corporate Secretary for Molecular Templates, Inc., a publicly traded, oncology-focused biotech, where she was responsible for providing legal counsel to the company’s board of directors and management team and advising on corporate governance, securities, employment, and real estate matters, among other areas. In this role, Ms. Filoon was responsible for managing the legal, human resources and administrative departments. She joined Molecular Templates as Corporate Counsel and during her time there, held roles of increasing responsibility, becoming General Counsel in February 2022. Prior to joining Molecular Templates, Ms. Filoon was a corporate associate at Blank Rome LLP, where she represented public and private companies in mergers and acquisitions, asset sales, securities offerings, business formation and corporate governance matters. She earned her Juris Doctor from Rutgers School of Law, where she was the Business Editor of the Rutgers Journal of Law and Public Policy, and her Bachelor of Arts in history and political science from Boston University. Thian Kheoh, Ph.D., has over 30 years of drug development and clinical trial experience in the biopharmaceutical industry. He most recently served as Vice President of Biometrics at Mirati Therapeutics where he led the Biometrics team in obtaining the FDA approval of KRAZATI® for KRAS G12C NSCLC patients. Prior to Mirati, he held roles of increasing responsibility at Tocagen, Janssen, Cougar Biotechnology, Biogen-Idec (now Biogen), TAP and Warner Lambert-Parke Davis. His work focused on exploring the application of statistical methodologies in preclinical and clinical studies, introducing novel statistical principles to trial design and strategic planning to bring effective drugs to cancer patients. Dr. Kheoh played an integral role in a number of successful global regulatory submissions and approvals of products that include ERLEADA®, DARZALEX®, OMNICEF®, SYLVANT®, VELCADE®, YONDELIS®, ZYTIGA® and the label expansion of RITUXAN®. Before joining the biopharmaceutical industry, he was an assistant professor at the University of Central Florida conducting research and providing lectures in Statistics. Dr. Kheoh earned his Ph.D. from the University of Western Ontario, Canada. About Elicio Therapeutics Elicio Therapeutics is a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer. By combining expertise in immunology and immunotherapy, Elicio is engineering investigational Amphiphile (AMP) immunotherapies intended to precisely target and fully engage the lymph nodes, the site in our bodies where the immune response is orchestrated. Elicio is engineering lymph node-targeted AMPlifiers, immunomodulators, adjuvants and vaccines for an array of aggressive cancers. Cautionary Note on Forward-Looking Statements Certain statements contained in this communication regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, known as the PSLRA. These include statements regarding Elicio’s planned clinical programs and statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, and therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Elicio undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by law. We use words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions of the PSLRA. Such forward-looking statements are based on our expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including, but not limited to Elicio’s plans to research, develop and commercialize its current and future product candidates. New factors emerge from time to time, and it is not possible for us to predict all such factors, nor can we assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. These risks are more fully discussed in the current report on Form 8-K that was filed with the SEC on June 2, 2023 and Elicio’s periodic reports and other documents filed from time to time with the SEC. Forward-looking statements included in this release are based on information available to Elicio as of the date of this release. Elicio does not undertake any obligation to update such forward-looking statements to reflect events or circumstances after the date of this release, except to the extent required by law. Media ContactGloria GasaaturaLifeSci Communicationsggasaatura@lifescicomms.com646-970-4688 Investor Relations ContactHeather DiVecchiaElicio TherapeuticsIR@elicio.com857-209-0153

Executive ChangeImmunotherapyVaccineDrug Approval

30 Mar 2023

·www.sciencedaily.com

Study finds excess harm from commonly overprescribed antibiotics for patients resulting in widespread side effects

A new study finds that overprescribing and inappropriate prescribing of antibiotics is not only leading to antibiotic resistance, but also causing significant patient harm. It's one of the most comprehensive studies to document the impact of antibiotic overuse in clinical practice. When patients request or demand an antibiotic, even when it is unlikely to help, a physician might be tempted to give in and write a prescription, especially if they're working in a busy setting like an urgent care or emergency department. However, a major new study by researchers at Intermountain Health and Stanford University finds that overprescribing and inappropriate prescribing of antibiotics is not only leading to antibiotic resistance -- but also causing significant patient harm. It's one of the most comprehensive studies to document the impact of antibiotic overuse in clinical practice. Every year, there are enough outpatient antibiotics prescribed in the US to cover 80% of the population. The new study, published in the Journal of Internal Medicine, examined 51 million patient encounters over a 15-year-period and focused on upper respiratory infections where antibiotics were known to be overprescribed 50% of the time. Researchers found that some of the most dangerous antibiotics were rarely indicated and commonly used, leading to one in 300 of those patients experiencing side effects dire enough to require a follow up doctor's visit -- or even hospitalization. This study was one of the few studies large enough to estimate serious, but rare, adverse events such as a potentially deadly diarrheal infection, Clostridium difficile. With previous studies showing 34 Million unnecessary antibiotic prescriptions annually in the US, this translates to real harm for many patients and families. "These findings underscore that inappropriately giving patients antibiotics is causing real and widespread harm," said Harris Carmichael, MD, principal investigator of the study and hospitalist at Intermountain Health in Salt Lake City. "Having these kinds of side effects for one in a few hundred, or even a thousand, patients may not seem like a lot, but when you look at this problem on a population health level, we're talking about hundreds of thousands of adverse events severe enough that these patients needed additional care from a doctor." That means time off work and school for families, unnecessary doctor visits, and risks of serious infections that can last for months or years. In the retrospective study, researchers from Intermountain and Stanford reviewed insurance claims from the Clinformatics Data Mark Database. Using data from Medicare Advantage and commercial insurance patients in all 50 states, inpatient and outpatient administrative claims, pharmaceutical claims, and patient demographics for beneficiaries seen between December 2002 and December 2017, they found 50.9 million claims for upper respiratory infections, including sinusitis, pharyngitis, laryngitis, bronchitis and the common cold, representing 23 million unique patients. Researchers then identified instances when patients did and did not receive oral antibiotics for an upper respiratory infection, and if those patients were diagnosed with either diarrhea, candidiasis, Clostridium difficile infection or a mix of these side effects thereafter. They found that 62.4% of these upper respiratory infection patients filled a prescription for an antibiotic, consistent with prior studies of this population. Following their initial visits, 26% of those patients had a follow-up outpatient visit within 14 days. The odds of a patient being diagnosed with an adverse event increased 30% for those receiving antibiotics. Adverse events following antibiotics were found in as many as one in 300 prescriptions, depending on the antibiotic prescribed, or one in 1,150 prescriptions overall. "With millions of visits for upper respiratory infections in the United States each year, the extent of these severe adverse events is significant," said Dr. Carmichael. Researchers also found that the antibiotic Cefdinir was the fourth most prescribed antibiotic for these patients, despite it rarely being recommended by prescription guidelines as an appropriate treatment for simple upper respiratory infections. This drug also had the second highest chance of leading to an adverse event. That means that patients are being prescribed a medication that is either not needed at all or unlikely to be the most appropriate medication for their condition and is routinely causing harm, said Dr. Carmichael. He added that the chance of adverse events is likely much higher, as these results only capture follow-up visits where their adverse event was coded as such for insurance purposes. That means the results do not include adverse events where physicians didn't code for that specific side effect, nor for patients who weren't sick enough to be seen in a doctor's office but may still have had additional and unnecessary time for recovery. These findings point to the increasingly important need for antibiotic stewardship programs, so that physicians are following prescribing guidelines and "only prescribe antibiotics when necessary, and then it's the right antibiotics for the right condition," said Dr. Carmichael. When Intermountain implemented their own enhanced antibiotic stewardship programs, which included explaining to patients why they weren't being prescribed an antibiotic if they asked for it, the health system reduced their overall prescribing rates by more than 15%. "Patients don't get upset when they don't get antibiotics, as long as we take the time to explain their condition and that we're treating them in the way that is best for them," said Dr. Carmichael.

Clinical Result

100 Deals associated with Cefdinir

External Link

KEGG	Wiki	ATC	Drug Bank
D00917	Cefdinir	J01DD15	DB00535

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Bronchitis	JP	LTL Pharma Co., Ltd.	27 Apr 2017
Cystitis	JP	LTL Pharma Co., Ltd.	27 Apr 2017
Otitis Media	JP	LTL Pharma Co., Ltd.	27 Apr 2017
Pneumonia, Bacterial	JP	LTL Pharma Co., Ltd.	27 Apr 2017
Sinusitis	JP	LTL Pharma Co., Ltd.	27 Apr 2017
Skin Diseases, Bacterial	JP	LTL Pharma Co., Ltd.	27 Apr 2017
Tonsillitis	JP	LTL Pharma Co., Ltd.	27 Apr 2017
Bacterial Infections	CN	Fujisawa Pharmaceutical Co., Ltd.	21 Apr 1999
Gram-Negative Bacterial Infections	-	-	01 Jan 1991
Gram-Positive Bacterial Infections	-	-	01 Jan 1991

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Otitis Media	Preclinical	DO	Abbott Laboratories	01 Jul 2002
Otitis Media	Discovery	CL	Abbott Laboratories	01 Jul 2002
Otitis Media	Discovery	DO	Abbott Laboratories	01 Jul 2002
Tonsillitis	Discovery	US	AbbVie, Inc.	04 Dec 1997

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02891915 (CTgov)	Phase 4	Community Acquired Pneumonia \| Cataract Anterior Polar Dominant	385	aminopenicillin+clavulanate+amoxicillin trihydrate+Cefdinir (Short Course)	srkujsvaxa(qgvjgupyeo): Pr (Higher DOOR in Short-Course) = 0.69 (95% CI, 0.63 - 0.75), P-Value = <0.001 View more	-	03 Feb 2021
				aminopenicillin+clavulanate+amoxicillin trihydrate+Amoxicillin-Clavulanate+Cefdinir (Standard Course)
NCT00835549 (CTgov)	Phase 1	-	32	Cefdinir (Cefdinir (Test))	(nqtlnrstlz) = ngdysuixgy ksszzqqjxz (nitcgucctg, zxszbgqqkf - kpwhkwwmof) View more	-	21 Jul 2009
				Omnicef (Omnicef® (Reference))	(nqtlnrstlz) = zmrptaxhrs ksszzqqjxz (nitcgucctg, gomjefjspw - yjpeavfwpb) View more
NCT00835484 (CTgov)	Phase 1	-	32	Cefdinir (Cefdinir (Test))	kobdbjkrsd(hgahmcsqjp) = owpgwoszzx zzufdulpnu (eruwfqrcwm, lribqgaifh - dcwraqfspd) View more	-	21 Jul 2009
				Omnicef (Omnicef® (Reference))	kobdbjkrsd(hgahmcsqjp) = qqmumixeef zzufdulpnu (eruwfqrcwm, yogomyorhu - oiejjurxnv) View more
NCT00834574 (CTgov)	Phase 1	-	32	Cefdinir (Cefdinir (Test))	(xirssrysjc) = hebbzrwjrq uhlzzseuzz (ddegdbngtu, sxswcathvb - ischuwuout) View more	-	21 Jul 2009
				Omnicef (Omnicef® (Reference))	(xirssrysjc) = mzpgonvcpm uhlzzseuzz (ddegdbngtu, hnmwdwofyh - zfbvsmstsp) View more
NCT00834535 (CTgov)	Phase 1	-	32	Cefdinir (Cefdinir (Test))	(hzdqkpgdgp) = srilsyyqlw gzikluimkf (bdggnurmiu, uzqrgwfxuc - atuzpuzlox) View more	-	21 Jul 2009
				Omnicef (Omnicef® (Reference))	(hzdqkpgdgp) = uitahnlhoi gzikluimkf (bdggnurmiu, butnnwgsmn - skgpvzqehx) View more

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