A Multi-centre, Randomised Trial Comparing a Novel Combination Treatment (Arm D - Intravenous Sulbactam-durlobactam in Combination With Intravenous Ceftriaxone, Oral Amoxicillin, Oral Azithromycin and Oral Clofazimine) Versus Standard of Care Treatments for the Intensive Phase of Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial

The goal of this clinical trial is to learn if a new combination antibiotic treatment (Arm D) works to treat a rare lung condition called mycobacterium abscessus pulmonary disease in people of any age and sex, when compared to the standard treatments. It will also learn about the safety of this new combination antibiotic treatment when compared to the standard treatments. The main questions it aims to answer are:
* How well does Arm D treat mycobacterium abscessus pulmonary disease?
* What side effects does Arm D cause when used to treat mycobacterium abscessus pulmonary disease? Researchers will compare Arm D to the current standard of care treatments to see if Arm D treats mycobacterium abscessus pulmonary disease better and if it will cause less side effects.
Participants will:
* Be screened and recruited to the FORMaT adaptive platform trial (NCT04310930)
* Be given Arm D for 4 weeks or standard of care treatments for 6 weeks.
* Be reviewed by the study doctors weekly for checkups and tests.
* Provide respiratory samples (sample coughed up from the chest), respond to quality-of-life questionnaires, have CT lung scans and blood tests.

Start Date01 Apr 2027

Sponsor / Collaborator

The University of Queensland

[+1]

NCT07672405

/ RecruitingPhase 2IIT

A Phase 2b, Randomised, Multi-center, Partially Blinded Trial Assessing the Safety and Efficacy of Regimens Containing Sorfequiline, Pretomanid and Linezolid in Adults With Newly Diagnosed, Drug-sensitive, Smear Positive Pulmonary Tuberculosis

The goal of this interventional trial is to evaluate the safety and efficacy of the loading dose regimen 200/100SPaL-4/13 weeks, and the 100SPaL -17 weeks regimen in adults with newly diagnosed, drug-sensitive, smear-positive pulmonary tuberculosis.
Participants (18-65 years) will be randomised 1:1, stratified by country and disease severity, to receive either :
1. a sorfequiline loading-dose regimen (200 mg daily for 4 weeks followed by 100 mg daily for 13 weeks) plus pretomanid 200 mg and linezolid 600 mg daily, or
2. sorfequiline 100 mg daily for 17 weeks plus pretomanid 200 mg and linezolid 600 mg daily. Study treatment is administered orally once daily with food.
The primary objective is to assess safety through 17 weeks of treatment, including treatment-emergent adverse events, ECG findings, vital signs, laboratory assessments, visual acuity, and peripheral neuropathy. Secondary objectives include assessments of efficacy (time to stable sputum culture conversion; favorable outcome and treatment failure/relapse at 26 and 52 weeks after end of treatment) and pharmacokinetics of trial drugs, with exploratory analyses including predictors of culture conversion, exposure-response relationships, and quality of life.

Start Date09 Jul 2026

Sponsor / Collaborator

Global Alliance for TB Drug Development

CTIS2026-526270-17-00

/ Not yet recruitingPhase 4IIT

Early switch to oral antibiotic therapy in vertebral osteomyelitis: a multicentre, open-label, randomised, active control, parallel group, non-inferiority trial (sWITCH-VO)

Start Date01 Jul 2026

Sponsor / Collaborator

Universities of Cologne

100 Clinical Results associated with Linezolid

100 Translational Medicine associated with Linezolid

100 Patents (Medical) associated with Linezolid

7,859

Literatures (Medical) associated with Linezolid

31 Dec 2026·RENAL FAILURE

Protective effects of adenosine triphosphate, thiamin, thiamin pyrophosphate, and their combination against linezolid-induced renal injury and lactic acidosis in rats

Article

Author: Mendil, Ali Sefa ; Suleyman, Halis ; Yavuzer, Bulent ; Yucel, Nurinisa ; Mammadov, Renad ; Admis, Ozlem ; Suleyman, Bahadir ; Altuner, Durdu

Linezolid, an oxazolidinone antibiotic effective against Gram-positive pathogens, may cause nephrotoxicity and lactic acidosis during prolonged therapy. This experimental study investigated the protective effects of adenosine triphosphate (ATP), thiamin, thiamin pyrophosphate (TPP), and their combination (ATTP) on linezolid-induced renal injury and lactic acidosis in rats. Thirty-six male Wistar rats were randomly divided into six groups (n = 6): healthy control (HG), linezolid only (LZD), ATP+linezolid (ATLZD), thiamin + linezolid (TLZD), TPP+linezolid (TPLZD), and ATP+thiamin + TPP+linezolid (ATTPL). Linezolid (125 mg/kg, orally) was administered twice daily, while ATP (4 mg/kg), thiamin (20 mg/kg), and TPP (20 mg/kg) were given intraperitoneally once daily for 28 days. At the end of treatment, kidney tissues were examined for oxidative stress markers [malondialdehyde (MDA), total glutathione (tGSH), superoxide dismutase (SOD), catalase (CAT)] and histopathology, and blood samples were analyzed for blood urea nitrogen (BUN), creatinine, and lactate. Linezolid increased oxidative stress, suppressed antioxidants, and elevated BUN, creatinine, and lactate levels. ATP partially improved the oxidative balance in renal tissue but failed to prevent hyperlactatemia and impaired renal function. Thiamin did not produce significant changes. TPP markedly improved oxidative stress markers and reduced renal dysfunction. The triple combination provided the most pronounced protection, restoring antioxidant defenses, kidney function, and lactate levels to near-control values. Histopathological evaluation revealed marked tubular degeneration, interstitial hemorrhage, and mononuclear cell infiltration in the linezolid group, which were markedly improved by TPP and combination therapy. These findings indicate that TPP protects against linezolid-induced nephrotoxicity and lactic acidosis, with its efficacy further enhanced by ATP.

31 Dec 2026·ANNALS OF MEDICINE

Efficacy and tolerability of linezolid as an adjunctive treatment for nontuberculous mycobacterial infections in patients with adult-onset immunodeficiency syndrome: a prospective cohort study

Article

Author: Suputtamongkol, Yupin ; Chirapapaisan, Niphon ; Angkasekwinai, Nasikarn ; Phoompoung, Pakpoom ; Foongladda, Suporn ; Chavapradit, Natthakit

BACKGROUND:

Patients with nontuberculous mycobacterial (NTM) diseases associated with anti-interferon gamma autoantibodies (anti-IFN-γ auto-Abs) often experience recurrences, despite prolonged treatment, which requires intravenous anti-mycobacterial therapy. Linezolid (LZD) shows a potential as an adjunct treatment, but there is limited data on its long-term efficacy and safety.

METHODS:

We conducted a prospective study from December 2017 to April 2022, to evaluate the efficacy of a nine-month oral LZD regimen in reducing NTM treatment failure, defined as relapse and the need for intravenous anti-mycobacterial therapy for suspected uncontrolled NTM or death as well as to determine its tolerability.

RESULTS:

Among 40 adults (≥18 years) with NTM diseases and anti-IFN-γ auto-Abs treated with linezolid, 10 (25%) discontinued treatment early due to adverse events (AEs), including one death from suspected uncontrolled diseases at month seven. Of the 30 patients who completed the nine-month course, only five maintained their initial dose. The remaining 25 required dose modification: four temporarily paused treatment due to AEs, nine reduced to a half dose due to AEs, and 12 reduced their dose because of stable disease. By month nine, the cumulative incidence rates of relapse and treatment failure were 22.5 and 15.0%, respectively; consequently, 77.5% and 85.0% of patients remained free from the relapse and treatment failure. Overall, 24 patients (60%) reported a total of 31 AEs, with anemia and peripheral neuropathy being the most frequent.

CONCLUSION:

Our findings suggest that linezolid could be a valuable adjunct treatment for nontuberculous mycobacteria diseases in patients with anti-interferon gamma autoantibodies. However, close monitoring for adverse events is essential.

01 Dec 2026·MOLECULAR BIOLOGY REPORTS

Phenotypic and genomic characterization of antimicrobial resistance in vancomycin-resistant Enterococcus faecalis

Article

Author: Tyagi, Anuj ; Gill, Jatinder Paul Singh ; Kaur, Simranpreet ; Singh, Randhir ; Parmar, Neha ; Arora, Anil Kumar

BACKGROUND:

Enterococcus faecalis has emerged as a significant nosocomial pathogen with increasing relevance at the human-animal interface. This study investigated the antimicrobial resistance (AMR) profiles and genomic characteristics of E. faecalis isolated from cattle farms in Punjab, India.

METHODS AND RESULTS:

A total of 288 samples, comprising cattle feces (239), cattle handler hand swabs (34), and handler stool samples (15), were processed using standard bacteriological protocols. Presumptive isolates were confirmed as E. faecalis by culture characteristics and Matrix-Assisted Laser Desorption Ionization-Time of Flight Mass Spectrometry (MALDI-TOF MS). Antimicrobial susceptibility testing (AST) was performed using the Kirby-Bauer disk diffusion method, and vancomycin resistance was confirmed by minimum inhibitory concentration (MIC) testing. Resistance genes were screened by polymerase chain reaction (PCR) and vancomycin-resistant isolates underwent whole-genome sequencing (WGS) for detailed genomic characterization. Overall, 51 E. faecalis isolates were recovered from 288 samples, yielding an overall prevalence of 17.70% (51/288). Sample-wise prevalence was 19.24% (46/239) in cattle feces, 8.82% (3/34) in hand swabs, and 13.33% (2/15) in stool samples. AST revealed high resistance rates to erythromycin (72.54%), linezolid (31.37%), ciprofloxacin and penicillin G (29.41% each), and tetracycline (27.45%). Phenotypic vancomycin resistance was identified in 5.88% (3/51) of isolates. PCR screening detected vanC1 in 31.37% and vanC2/C3 in 33.33% of isolates, although their presence was not uniformly associated with phenotypic resistance.WGS of three vancomycin-resistant E. faecalis isolates identified resistance genes, virulence determinants, and a shared multilocus sequence type (MLST), ST-387, among isolates from cattle and handlers.

CONCLUSIONS:

These findings highlight cattle farms as reservoirs of multidrug resistant (MDR) and virulent E. faecalis strains, emphasizing the importance of genomic surveillance to prevent the dissemination of these strains into healthcare settings.

119

News (Medical) associated with Linezolid

30 Jun 2026

·www.biospace.com

Provectus Biopharmaceuticals and VisiRose Announce U.S. Patent Award for Light-Independent Antibacterial Eye Drop Targeting Drug-Resistant Ocular Infections

New IP covers topical rose bengal sodium ophthalmic composition against MRSA and other resistant Gram-positive bacteria without requiring light activation. VisiRose to hold exclusive ophthalmic license. KNOXVILLE, Tenn., June 30, 2026 (GLOBE NEWSWIRE) -- Provectus Biopharmaceuticals, Inc. (“Provectus” or the “Company”) (OTCQB: PVCT), a clinical-stage biotechnology company developing pharmaceutical grade rose bengal sodium (“RBS”) active pharmaceutical ingredient (“API”) as a platform therapeutic, and VisiRose, Inc. (“VisiRose”), Provectus’s clinical-stage ophthalmology subsidiary, today announced the issuance of U.S. Patent No. 12,661,335, titled “Halogenated Xanthene-Containing Topical Anti-Gram-Positive Bacterial Ophthalmic Composition and Method.” The patent covers a topical eye drop formulation of RBS API for treating Gram-positive bacterial keratitis, including drug-resistant strains such as MRSA and vancomycin-resistant Enterococcus. Why it matters: The data underlying the patent show RBS killing resistant Gram-positive bacteria and eradicating biofilms in the dark, with no light step required. That opens the door to a self-administered eye drop with the same use pattern as existing prescription antibiotic drops but aimed at resistant infections those drugs no longer reliably treat. What the patent covers: Light-independent killing. Claims cover antibacterial activity in the substantial absence of activating light. Resistant-pathogen coverage. Claimed effective concentrations span methicillin- and vancomycin-resistant S. aureus and drug-resistant E. faecalis and E. faecium . These are among the organisms where first-line antibiotics are failing. Biofilm eradication. Chronic, recurrent ocular infections are often biofilm-driven and tolerant to standard antibiotics, including linezolid. The claimed composition eradicates biofilms in both light and dark conditions. Defined, tear-compatible formulation. Claims fix concentration (about 0.2 to 50 μg/mL), pH (6.5 to 7.6, matching normal human tear pH), viscosity, and osmolality. These are specifications aimed at ocular tolerability and FDA formulation review. Wide safety margin. In preclinical testing, the cytotoxicity threshold in mammalian cells sat well above the concentrations needed to kill resistant bacteria, the gap a potential topical product needs to support repeat dosing. Market and disease implications: A light-independent formulation is structurally a standard eye drop. It can be prescribed, dispensed, and self-administered the way chloramphenicol or fluoroquinolone drops are today, but for resistant-organism infections those drugs increasingly cannot clear. That bears most directly on: Bacterial keratitis caused by drug-resistant Gram-positive organisms, a leading cause of preventable corneal blindness and a recurring diagnosis in contact lens wearers. Chronic and recurrent blepharitis and conjunctivitis , where biofilm tolerance limits the durability of standard antibiotic regimens. Contact-lens-associated infections , a population for whom a take-home, light-free drop is a meaningfully different treatment experience. Platform note: RBS is the proprietary synthetic small molecule and API underlying Provectus’s clinical-stage oncology and dermatology programs and VisiRose’s clinical-stage ophthalmology program. The patent award extends that platform’s ophthalmology intellectual property (“IP”) footprint. VisiRose is being granted an exclusive license to it to develop and commercialize ophthalmic applications under its field license from Provectus. The patent issues from U.S. Application No. 18/089,134, filed December 27, 2022 and claiming priority to a provisional application filed December 28, 2021. The University of Tennessee Research Foundation is a co-assignee on the patent. Ed Pershing, Chairman, Board of Directors, VisiRose and Chairman, Board of Directors and Chief Executive Officer, Provectus, said, “This patent gives us composition and method protection for a finding that matters deeply: rose bengal sodium can kill resistant Gram-positive bacteria, including MRSA, and eradicate their biofilms without a light-activation step. It’s intellectual property that further strengthens the case for our proprietary rose bengal sodium as a platform molecule.” About Provectus Provectus Biopharmaceuticals, Inc. is a clinical-stage biotechnology company developing a pipeline of immunotherapy medicines based on rose bengal sodium, a first-in-class synthetic small molecule from the halogenated xanthene family. The Company’s clinical programs span oncology, dermatology, and ophthalmology, with additional proof-of-concept and early discovery programs in hematology, wound healing, infectious diseases, tissue repair, and neurodegeneration. For more information, visit . About VisiRose VisiRose is a clinical-stage biotechnology company of the University of Miami and Provectus Biopharmaceuticals, focused on commercializing the Miller School of Medicine’s Bascom Palmer Eye Institute and its Ophthalmic Biophysics Center’s innovative ocular research in infectious keratitis using Provectus’s synthetic small molecule rose bengal sodium. For more information, please visit . Forward Looking Statements The information in this press release may include “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, relating to the business of Provectus and its affiliates, which are based on currently available information and current assumptions, expectations, and projections about future events and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements. Forward-looking statements are often, but not always, identified by the use of words such as “aim,” “likely,” “outlook,” “seek,” “anticipate,” “budget,” “plan,” “continue,” “estimate,” “expect,” “forecast,” “may,” “will,” “would,” “project,” “projection,” “predict,” “potential,” “targeting,” “intend,” “can,” “could,” “might,” “should,” “believe,” and similar words suggesting future outcomes or statements regarding an outlook. The safety and efficacy of the agents and/or uses under investigation have not been established. There is no guarantee that the agents will receive health authority approval or become commercially available in any country for the uses being investigated or that such agents as products will achieve any particular revenue levels. Due to the risks, uncertainties, and assumptions inherent in forward-looking statements, readers should not place undue reliance on these forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof or as of the date specifically specified herein, and Provectus undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except in accordance with applicable securities laws. The forward-looking statements are expressly qualified by this cautionary statement. Risks, uncertainties, and assumptions include those discussed in the Company’s filings with the Securities and Exchange Commission, including those described in Item 1A of the Company’s Annual Report on Form 10-K for the period ended December 31, 2025 and Quarterly Report on Form 10-Q for the period ended March 31, 2026 . Contacts: Provectus Biopharmaceuticals, Inc. Heather Raines, CPA Chief Financial Officer hraines@pvct.com (866) 594-5999 Investor Relations & Media Susan Xu sxu@allianceadvisors.com (778) 323-0959

09 Jun 2026

·www.biospace.com

Tris Pharma Introduces a New 60 mL Bottle Size for DYANAVEL® XR (amphetamine) Extended-Release Oral Suspension CII

A new, smaller 60 mL bottle brings pharmacy-stocking and dosing convenience to a once-daily liquid amphetamine designed for individualized titration in ADHD MONMOUTH JUNCTION, N.J., June 08, 2026 (GLOBE NEWSWIRE) -- Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company advancing transformative targeted CNS therapeutics, today announced the availability of DYANAVEL® XR (amphetamine) extended-release oral suspension, CII (2.5 mg/mL) in a new, smaller 60 mL bottle (NDC 24478-102-02). DYANAVEL XR is a once-daily liquid treatment for attention deficit hyperactivity disorder (ADHD) in patients 6 years and older. The new 60 mL bottle size of DYANAVEL XR offers a more convenient size for pharmacy stocking and dispensing and is available through major wholesalers, including Cardinal Health, Cencora, and McKesson. The smaller size is aligned with the approved doses of Dyanavel XR with each 60 mL bottle providing 30 days of the starting dose of 5 mg/day. “This new bottle size is intended to make DYANAVEL XR easier for pharmacies to stock and, in turn, easier for patients to access,” said Manesh Naidu, Chief Commercial Officer of Tris Pharma. “Pharmacists can now dispense whole bottles to patients for the most commonly prescribed doses while still being able to dispense partial bottles if needed.” Tris Pharma plans to phase out the larger 464 mL bottle which will be discontinued as the supply switches over to 60 mL bottle size. Storage and handling requirements as well as expiration dating will remain the same for both bottle sizes. No changes have been made to the formulation of DYANAVEL XR. The manufacturer’s price of the medication has not changed with the cost per mL remaining the same in the new 60 mL bottle size. About Tris Pharma, Inc. Tris Pharma, Inc. is a privately held, innovation-driven biopharmaceutical commercial-stage company that is applying drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain, and disorders of the central nervous system into advanced, targeted drug delivery. Tris markets a portfolio of best-in-class ADHD products and is developing a robust pipeline of differentiated near-term drug candidates. For more information, visit . Indication DYANAVEL XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older. Limitations of Use The use of DYANAVEL XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage. Important Safety Information WARNING: ABUSE, MISUSE, AND ADDICTION DYANAVEL XR has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including DYANAVEL XR, can result in overdose and death. Before prescribing DYANAVEL XR, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction. DYANAVEL XR is contraindicated: In patients known to be hypersensitive to amphetamine, or other components of DYANAVEL XR. Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported with other amphetamines. In patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of increased risk of hypertensive crisis. Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD doses. Serious cardiovascular effects with overdose may precipitate sudden cardiac death. Prior to treating patients with DYANAVEL XR, assess for the presence of cardiac disease. Avoid DYANAVEL XR use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during DYANAVEL XR treatment. CNS stimulants cause increase in blood pressure (mean increase about 2 to 4 mm Hg) and heart rate (mean increase about 3 to 6 bpm). Monitor all patients for potential tachycardia and hypertension. Use of CNS stimulants may cause exacerbation of pre-existing psychosis and may induce maniac or mixed episode in patients with bipolar disorder. In patients without prior history of psychotic illness or mania, CNS stimulants may cause new psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) at the recommended dosage. Prior to initiating DYANAVEL XR treatment, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing DYANAVEL XR. CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. DYANAVEL XR is not approved for use and is not recommended in pediatric patients below 6 years of age. Closely monitor height and weight in DYANAVEL XR treated pediatric patients treated with CNS stimulants. Treatment may need to be interrupted in children not growing or gaining height or weight as expected. CNS stimulants, including DYANAVEL XR, are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; very rare sequelae include digital ulceration and/or soft tissue breakdown. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for DYANAVEL XR-treated patients who develop signs or symptoms of peripheral vasculopathy. Serotonin syndrome risk is increased when co-administered with serotonergic agents (e.g., SSRIs, SNRIs, triptans), MAOIs, and during overdosage situations. If it occurs, discontinue DYANAVEL XR and any concomitant serotonergic agents immediately, and initiate supportive treatment. CNS stimulants, including amphetamine, have been associated with the onset or exacerbation of motor and verbal tics. Worsening of Tourette’s syndrome has also been reported. Before initiating DYANAVEL XR, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor DYANAVEL XR-treated patients for the emergence or worsening of tics or Tourette’s syndrome and discontinue treatment if clinically appropriate. Most common adverse reactions observed with amphetamine products: dry mouth, anorexia, weight loss, abdominal pain, nausea, insomnia, restlessness, emotional lability, dizziness, and tachycardia. Based on limited experience with DYANAVEL XR in controlled trials, the adverse reaction pro DYANAVEL XR appears similar to other amphetamine extended-release products. The most common (≥2% in the DYANAVEL XR group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 108 patients with ADHD (aged 6 to 12 years) were: epistaxis (DYANAVEL XR 4%, placebo 0%), allergic rhinitis (4%, 0%) and upper abdominal pain (4%, 2%). DYANAVEL XR use during pregnancy may cause fetal harm. To monitor pregnancy outcomes in women exposed to DYANAVEL XR during pregnancy, healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visiting online at . Because of the potential for serious adverse reactions in a breastfed infant, breastfeeding is not recommended during treatment with DYANAVEL XR. To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, Inc. at 1-732-940-0358 or FDA at 1-800-FDA-1088 or . Please see Full Prescribing Information , including Boxed Warning regarding ABUSE, MISUSE, AND ADDICTION DYANAVEL ® and Liqui XR ® are registered trademarks of Tris Pharma, Inc. Contact: Cheryl Patnick Tris Pharma 732-823-4940 Media Contact: Madelin Hawtin LifeSci Communications MHawtin@lifescicomms.com

Phase 3Drug ApprovalClinical Result

14 May 2026

·www.biospace.com

Aytu BioPharma Reports Fiscal 2026 Third Quarter Operational and Financial Results

EXXUA -- with only a partial quarter of full sales force support -- contributed $2.4 million in net revenue supported by rapid monthly compounding script growth rates Total net revenue of $12.4 million Adjusted EBITDA 1 of $(2.8) million, which includes EXXUA ™ (gepirone) extended-release tablets ( " EXXUA " ) launch investments as the Company enters the over $22 billion United States prescription major depressive disorder ( " MDD " ) market $26.7 million cash balance at March 31, 2026 Company to host conference call and webcast today, May 13, 2026, at 4:30 p.m. Eastern time DENVER, CO / ACCESS Newswire / May 13, 2026 / Aytu BioPharma, Inc. (the "Company" or "Aytu") (Nasdaq:AYTU), a pharmaceutical company focused on advancing innovative medicines for complex central nervous system diseases to improve the quality of life for patients, today announced operational and financial results for the fiscal 2026 third quarter. Q3 Fiscal 2026 Highlights Net revenue of $12.4 million versus $18.5 million in Q3 fiscal 2025. EXXUA net revenue was $2.4 million during Q3 fiscal 2026. EXXUA was only made commercially available in mid-December 2025, and more formally launched in mid-January 2026 following the completion of sales force training highlighting strong adoption in the initial weeks of the full launch. ADHD Portfolio, which consists of attention deficit hyperactivity disorder ("ADHD") products, net revenue was $9.1 million versus $15.4 million in Q3 fiscal 2025. The change in net revenue is primarily due to a transition of sales force prioritization toward EXXUA and the recent introduction of generic competition. Pediatric Portfolio, which consists of a line of legacy products, net revenue was $0.9 million versus $3.1 million in Q3 fiscal 2025. Net loss of $5.6 million included a $1.3 million derivative warrant liability loss primarily due to the increase in the Company's stock price, compared to net income of $4.0 million in Q3 fiscal 2025, which included a $2.3 million derivative warrant liability gain. Adjusted EBITDA was $(2.8) million compared to $3.9 million in Q3 fiscal 2025. During Q3 fiscal 2026, the Company made planned investments towards the launch of EXXUA. Cash and cash equivalents were $26.7 million at March 31, 2026. Management Discussion "Although we remain in the very early stages of the EXXUA launch, the initial traction we are seeing is highly encouraging," commented Josh Disbrow, Chief Executive Officer of Aytu. "Since the formal launch in mid-January, we have seen strong month-over-month growth, with more than 1,300 prescriptions written in the quarter by more than 450 unique prescribers. Importantly, the growth we are seeing in titration packs, together with early refill activity, reinforces our belief that EXXUA is beginning to have a meaningful impact for patients and that prescribers are increasingly recognizing its differentiated role in the treatment of MDD. We are also pleased with the execution across our channel partners, as sales of more than 3,200 units demonstrate their preparedness to support the compounding growth trajectory we anticipate as awareness, access and utilization continues to expand. While the first few months of any launch naturally include noise as coverage, gross-to-net dynamics and pharmacy ordering and prescribing patterns settle, the trends we are seeing are quite positive. Overall, we are very pleased with the launch fundamentals to date and remain focused on driving disciplined, efficient commercial execution as we work to build EXXUA into an important treatment option for the millions of Americans living with major depressive disorder." "Our legacy business, including our ADHD and Pediatrics portfolios, continue to provide an important foundation for Aytu as we transition and prioritize resources behind the high-growth EXXUA opportunity," Disbrow continued. "As expected, the decrease in ADHD Portfolio net revenue during the quarter was primarily attributable to that strategic transition of sales force focus toward EXXUA, which started late last summer, as well as the recent introduction of generic competition for Adzenys XR-ODT ® . That said, we continue to believe our ADHD Portfolio will remain a meaningful contributor moving forward and given the level of commercial support currently behind the portfolio, our ADHD Portfolio remains highly profitable on a standalone basis and continues to demonstrate the durability of these brands and the attractive economics of our commercial platform. Our Pediatric Portfolio net revenue decrease is attributable primarily to payor changes that have impacted prescribing and an increase in returns. As we continue to execute the EXXUA commercialization plans, we remain focused on balancing disciplined investment in our highest-growth opportunity with continued profitability and cash generation from our legacy operations." "Looking ahead, we are extremely excited by EXXUA's unique and transformational opportunity, supported by a large $22 billion market, rapid initial adoption, strong refill rates and attractive unit economics. When combined with our effective and efficient launch strategy and the cash flow contribution from our legacy operations, we believe these dynamics position Aytu to drive sustained growth and long-term shareholder value," Disbrow concluded. Net Revenue by Product Portfolio Three Months Ended March 31, 2026 2025 (in thousands) EXXUA $ 2,397 $ - ADHD Portfolio 9,093 15,389 Pediatric Portfolio 921 3,059 Other* - 4 Total net revenue $ 12,411 $ 18,452 ____________________ * Other includes discontinued or deprioritized products. Q3 Fiscal 2026 Financial Results Net revenue for the third quarter of fiscal 2026 was $12.4 million, compared to $18.5 million for the prior year period. EXXUA net revenue was $2.4 million. EXXUA was made commercially available in mid-December 2025, and more formally launched in mid-January 2026 following the completion of sales force training, followed by full sales force deployment in late February. Net revenue is attributable to a combination of scripts written and filled during the quarter, as well as inventory channel stocking to meet prescription growth expectations. The ADHD Portfolio net revenue was $9.1 million in the third quarter of fiscal 2026, compared to $15.4 million in the prior year period. The decrease is attributable to a decrease in total prescriptions primarily due to broader deemphasis in marketing of the ADHD Portfolio as the Company's marketing efforts have shifted towards EXXUA, which is now the centerpiece of its commercial efforts, as well as the introduction of Adzenys XR-ODT ® ("Adzenys") generic competition. The Pediatric Portfolio net revenue was $0.9 million in the third quarter of fiscal 2026, compared to $3.1 million in the prior year period. The change in net revenue is attributable primarily to payor changes impacting prescribing of the Pediatric Portfolio and an increase in returns. Gross profit was $7.6 million, or 61% of net revenue, in the third quarter of fiscal 2026, compared to $12.8 million, or 69% of net revenue, in the same quarter last year. The decrease in gross profit percentage is primarily related to a $6.0 million decrease in net revenue driven by a broader deemphasis in marketing towards the ADHD Portfolio and payor changes affecting the Pediatric Portfolio as our marketing efforts have shifted from the ADHD Portfolio towards EXXUA and a $0.7 million inventory write-down recorded to cost of goods sold primarily resulting from a shift from our Adzenys branded products to the Adzenys generic products. Operating expenses, excluding amortization of intangible assets, were $10.9 million in the third quarter of fiscal 2026 compared to $9.5 million in the prior year period. The increase is primarily a result of increased EXXUA launch investments partially offset by improved operational efficiencies such as reduced facilities expense. Net loss during the third quarter of fiscal 2026 was $5.6 million, or $0.53 net loss per share basic compared to net income of $4.0 million, or $0.65 net income per share basic, in the prior year period. The fiscal 2026 and fiscal 2025 third quarter results were impacted by derivative warrant liability loss of $1.3 million and a gain of $2.3 million, respectively, primarily due to changes in the Company's stock price. Adjusted EBITDA was $(2.8) million for the third quarter of fiscal 2026 compared to $3.9 million in the year ago period. The change primarily relates to planned investments towards the launch of EXXUA. As previously announced, on March 31, 2026, the Company amended and restated certain warrants, which resolved the accounting ambiguity that previously required these warrants to be classified as liabilities rather than equity. As a result, the Company reduced its derivative warrant liabilities by $26.4 million and increased stockholders' equity by that same amount on March 31, 2026, while significantly reducing future non-cash earnings volatility associated with derivative warrant liability gains and losses. As of March 31, 2026, stockholders' equity was $35.1 million compared to $14.2 million at December 31, 2025. As of March 31, 2026, combining both equity classified prefunded warrants and issued and outstanding common shares, there were 19.5 million shares utilized for calculating the basic weighted-average shares outstanding for earnings per share purposes. Cash and cash equivalents were $26.7 million at March 31, 2026, compared to $31.0 million at June 30, 2025. Conference Call Details Date and Time: Wednesday, May 13, 2026, at 4:30 p.m. Eastern time. Call-in Information: Interested parties can access the conference call by dialing (888) 506-0062 for United States callers or +1 (973) 528-0011 for international callers and using the participant access code 273453. Webcast Information: The webcast will be accessible live and archived at , and accessible on the Investors section of the Company's website at under Events & Presentations. Replay: A teleconference replay of the call will be available until May 27, 2026, at (877) 481-4010 for United States callers or +1 (919) 882-2331 for international callers and using replay access code 53861. About Aytu BioPharma Aytu is a pharmaceutical company focused on advancing innovative medicines for complex central nervous system diseases to improve the quality of life for patients. The Company's prescription products include EXXUA ™ (gepirone) extended-release tablets (see Full Prescribing Information, including Boxed WARNING) for the treatment of major depressive disorder (MDD), and treatments for attention deficit-hyperactivity disorder (ADHD). Aytu is committed to delivering the Company's medications through best-in-class patient access programs that help to enable optimal patient outcomes. For more information, please visit aytubio.com or follow us on LinkedIn . About EXXUA EXXUA is a novel oral selective serotonin 5-HT1A receptor agonist indicated for the treatment of major depressive disorder (MDD) in adults. IMPORTANT SAFETY INFORMATION WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increase the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. EXXUA is not approved for use in pediatric patients. INDICATIONS AND USAGE EXXUA is indicated for the treatment of major depressive disorder (MDD) in adults. DOSAGE AND ADMINISTRATION Important Recommendations Prior to Initiating and During Treatment with EXXUA Electrocardiogram and Electrolyte Monitoring Correct electrolyte abnormalities prior to initiating EXXUA. In patients with electrolyte abnormalities, or who are receiving diuretics or glucocorticoids, or who have a history of hypokalemia or hypomagnesemia, also monitor electrolytes during dose titration and periodically during treatment with EXXUA. Perform an electrocardiogram (ECG) prior to initiating EXXUA, during dosage titration, and periodically during treatment. Do not initiate EXXUA if QTc is > 450 msec at baseline. Monitor ECGs more frequently if EXXUA is used: concomitantly with drugs known to prolong the QT interval in patients who develop QTc ≥ 450 msec during treatment in patients with a significant risk of developing torsade de pointes Do not escalate the EXXUA dosage if the QTcF is > 450 msec. Bipolar Disorder, Mania, and Hypomania Screening Screen patients for a personal or family history of bipolar disorder, mania, or hypomania prior to initiating treatment with EXXUA. Important Administration Instructions Take EXXUA orally with food at approximately the same time each day. Swallow tablets whole. Do not split, crush, or chew EXXUA. Recommended Dosage The recommended starting dosage of EXXUA is 18.2 mg once daily. Based on clinical response and tolerability, the dosage may be increased to 36.3 mg orally once daily on Day 4 and further titrated to 54.5 mg orally once daily after Day 7 and to 72.6 mg orally once daily after an additional week. The maximum recommended daily dosage of EXXUA is 72.6 mg once daily. Dosage Recommendations in Geriatric Patients The recommended starting dosage of EXXUA in geriatric patients is 18.2 mg orally once daily. Based on clinical response and tolerability, the dosage may be increased to maximum recommended dosage of 36.3 mg orally once daily after Day 7. Recommended Dosage in Patients with Renal Impairment The recommended starting dosage of EXXUA in patients with creatinine clearance 450 msec at baseline. with congenital long QT syndrome. receiving concomitant strong CYP3A4 inhibitors. with severe hepatic impairment. taking, or within 14 days of stopping, MAOIs due to the risk of serious and possibly fatal drug interactions, including hypertensive crisis and serotonin syndrome. Starting EXXUA in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is also contraindicated. WARNINGS AND PRECAUTIONS Suicidal Thoughts and Behaviors in Adolescents and Young Adults In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients, and 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients aged 24 years and younger was greater than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied. There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with MDD. *EXXUA is not approved for use in pediatric patients. Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing EXXUA, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors. QT Prolongation EXXUA prolongs the QTc interval. EXXUA is contraindicated in patients with congenital long QT syndrome and in patients with severe hepatic impairment or in patients receiving concomitant strong CYP3A4 inhibitors as they increase EXXUA plasma concentrations. Do not initiate EXXUA if QTc is > 450 msec at baseline. Correct electrolyte abnormalities prior to EXXUA initiation. In patients with electrolyte abnormalities, who are receiving diuretics or glucocorticoids, or have a history or hypokalemia or hypomagnesemia, also monitor electrolytes during dose titration and periodically during treatment with EXXUA. Perform an ECG prior to EXXUA initiation, during dosage titration, and periodically during treatment. Monitor patients with ECGs more frequently: If EXXUA is used concomitantly with drugs known to prolong the QT interval. In patients who develop QTc ≥ 450 msec during treatment with EXXUA. Do not escalate the EXXUA dosage if QTcF is > 450 msec. In patients with a significant risk of developing torsade de pointes, including those with uncontrolled or significant cardiac disease, recent myocardial infarction, heart failure, unstable angina, bradyarrhythmias, uncontrolled hypertension, high degree atrioventricular block, severe aortic stenosis, or uncontrolled hypothyroidism. Reduce the EXXUA dosage when used concomitantly with moderate CYP3A4 inhibitors, as they may increase EXXUA concentrations. Serotonin Syndrome Concomitant use of EXXUA with SSRIs or tricyclic antidepressants may cause serotonin syndrome, a potentially life-threatening condition with changes including altered mental status, hypertension, restlessness, myoclonus, hyperthermia, hyperreflexia, diaphoresis, shivering, and tremor. The concomitant use of EXXUA with MAOIs is contraindicated. In addition, do not initiate EXXUA in a patient being treated with MAOIs such as linezolid or intravenous methylene blue. If it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking EXXUA discontinue EXXUA before initiating treatment with the MAOI. If concomitant use of EXXUA with other serotonergic drugs is clinically warranted, inform patients of the increased risk for serotonin syndrome and monitor for symptoms. Discontinue EXXUA and/or concomitant serotonergic drug immediately if the above symptoms occur and initiate supportive symptomatic treatment. Activation of Mania or Hypomania Antidepressant treatment can precipitate a manic, mixed, or hypomanic manic episode. The risk appears to be increased in patients with bipolar disorder or who have risk factors for bipolar disorder. Prior to initiating treatment with EXXUA, screen patients for a history of bipolar disorder and the presence of risk factors for bipolar disorder (e.g., family history of bipolar disorder, suicide, or depression). EXXUA is not approved for use in treating bipolar depression. ADVERSE REACTIONS Most common adverse reactions (incidence of ≥5% and at least twice incidence of placebo) were dizziness, nausea, insomnia, abdominal pain, and dyspepsia. The following adverse reactions are discussed in greater detail in other sections of the labeling: Suicidal Thoughts and Behaviors in Adolescents and Young Adults QT Prolongation Serotonin Syndrome Activation of Mania or Hypomania To report SUSPECTED ADVERSE REACTIONS, contact Aytu BioPharma at 1-855-298-8246 or or FDA at 1-800-FDA-1088 or . USE IN SPECIFIC POPULATIONS Pregnancy The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including EXXUA, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-866-961-2388 or visiting online at . Lactation There is no data on the presence of gepirone in human milk, the effects on the breastfed infant, or the effects on milk production. Gepirone is present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. There are reports of breastfed infants exposed to other serotonergic antidepressants experiencing irritability, restlessness, excessive somnolence, decreased feeding, and weight loss. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for EXXUA and any adverse effects on the breastfed infant from EXXUA or from the underlying maternal condition. OVERDOSAGE In clinical studies, cases of acute ingestions up to 454 mg (6.25 times the maximum recommended dose) of EXXUA alone or in combination with other drugs, were reported. Signs and symptoms reported with overdose of EXXUA at doses up to 454 mg included vomiting and transient incomplete bundle branch block; an unknown dose of EXXUA produced altered level of consciousness and a 60-second convulsion. No specific antidotes for EXXUA are known. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations. Please see Full Prescribing Information for EXXUA. Footnote 1 Aytu uses the term adjusted EBITDA, which is a term not defined under United States generally accepted accounting principles ("U.S. GAAP"). The Company uses this term because it is a widely accepted financial indicator utilized to analyze and compare companies on the basis of operating performance. The Company believes that presenting adjusted EBITDA by certain categories allows investors to evaluate the various performance of these categories. The Company's method of computation of adjusted EBITDA may or may not be comparable to other similarly titled measures used by other companies. The Company believes that net (loss) income is the performance measure calculated and presented in accordance with U.S. GAAP that is most directly comparable to adjusted EBITDA. See below for a reconciliation of net (loss) income to adjusted EBITDA. Forward-Looking Statements This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended ("Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended ("Exchange Act"). All statements other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as "may," "will," "should," "forecast," "could," "expect," "suggest," "believe," "estimate," "continue," "anticipate," "intend," "plan," or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. These statements are predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others, risks associated with: the Company's overall financial and operational performance, potential adverse changes to the Company's financial position or its business, the results of operations, strategy and plans, changes in capital markets and the ability of the Company to finance operations in the manner expected, risks relating to gaining market acceptance of its products, its partners performing their required activities, its anticipated future cash position, regulatory and compliance challenges and future events under current and potential future collaborations. The Company also refers you to (i) the risks described in "Risk Factors" in Part I, Item 1A of the Company's most recent Annual Report on Form 10‑K and in the other reports and documents it files with the United States Securities and Exchange Commission. Contacts for Investors Ryan Selhorn, Chief Financial Officer Aytu BioPharma, Inc. rselhorn@aytubio.com Robert Blum Lytham Partners aytu@lythampartners.com Aytu BioPharma, Inc. Unaudited Consolidated Statements of Operations (in thousands, except share and per share data) Three Months Ended March 31, 2026 2025 Net revenue $ 12,411 $ 18,452 Cost of goods sold 4,812 5,646 Gross profit 7,599 12,806 Operating expenses: Selling and marketing 5,929 5,194 General and administrative 4,973 4,109 Research and development - 162 Amortization of intangible assets 761 920 Total operating expenses 11,663 10,385 (Loss) income from operations (4,064 ) 2,421 Other income, net 149 36 Interest expense (436 ) (900 ) Derivative warrant liabilities (loss) gain (1,257 ) 2,261 (Loss) income from continuing operations before income tax expense (5,608 ) 3,818 Income tax (expense) benefit (10 ) 122 Net (loss) income from continuing operations (5,618 ) 3,940 Net income from discontinued operations, net of tax - 54 Net (loss) income $ (5,618 ) $ 3,994 Basic weighted-average common shares outstanding 10,511,583 6,134,634 Diluted weighted-average common shares outstanding 10,511,583 8,204,453 Net (loss) income per share: Basic - continuing operations $ (0.53 ) $ 0.64 Diluted - continuing operations $ (0.53 ) $ 0.20 Basic - discontinued operations, net of tax $ - $ 0.01 Diluted - discontinued operations, net of tax $ - $ 0.01 Basic - net (loss) income $ (0.53 ) $ 0.65 Diluted - net (loss) income $ (0.53 ) $ 0.21 Aytu BioPharma, Inc. Unaudited Consolidated Balance Sheets (in thousands, except share data) March 31, June 30, 2026 2025 ASSETS Current assets: Cash and cash equivalents $ 26,715 $ 30,952 Accounts receivable, net 24,489 31,155 Inventories 7,460 11,434 Prepaid expenses and other current assets 8,662 5,638 Total current assets 67,326 79,179 Non-current assets: Property and equipment, net 407 532 Operating lease right-of-use assets 910 1,061 Intangible assets, net 42,490 42,201 Other non-current assets 556 1,204 Total non-current assets 44,363 44,998 Total assets $ 111,689 $ 124,177 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 13,214 $ 10,601 Accrued liabilities 34,270 38,164 Revolving credit facility 10,411 9,063 Current portion of debt 1,857 1,857 Other current liabilities 220 3,379 Total current liabilities 59,972 63,064 Non-current liabilities: Debt, net of current portion 9,549 10,895 Derivative warrant liabilities 2,182 26,334 Other non-current liabilities 4,843 4,918 Total non-current liabilities 16,574 42,147 Stockholders' equity: Preferred stock, par value $0.0001; 50,000,000 shares authorized; no shares issued or outstanding - - Common stock, par value $0.0001; 200,000,000 shares authorized; 10,733,208 and 8,976,913 shares issued and outstanding, respectively 1 1 Additional paid-in capital 382,914 352,500 Accumulated deficit (347,772 ) (333,535 ) Total stockholders' equity 35,143 18,966 Total liabilities and stockholders' equity $ 111,689 $ 124,177 Aytu BioPharma, Inc. Unaudited Reconciliation of Net (Loss) Income to Adjusted EBITDA (in thousands) Three Months Ended March 31, 2026 2025 Net (loss) income - GAAP $ (5,618 ) $ 3,994 Interest expense 436 900 Income tax expense (benefit) 10 (122 ) Depreciation and amortization 1,121 1,287 Stock-based compensation expense 148 139 Other income, net (149 ) (36 ) Derivative warrant liabilities loss (gain) 1,257 (2,261 ) Pipeline research and development costs - 96 Net income from discontinued operations, net of tax - (54 ) Adjusted EBITDA - non-GAAP $ (2,795 ) $ 3,943 SOURCE: Aytu BioPharma, Inc. View the original press release on ACCESS Newswire

100 Deals associated with Linezolid

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KEGG	Wiki	ATC	Drug Bank
D00947	Linezolid	J01XX08	DB00601

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Skin and skin structure infections	United States	Hospira, Inc.	18 Jun 2015
Bacteremia	China	Pfizer Inc.	12 Sep 2006
Complicated skin and soft tissue infection	China	Pfizer Inc.	12 Sep 2006
Healthcare-Associated Pneumonia	China	Pfizer Inc.	12 Sep 2006
Pneumonia	China	Pfizer Inc.	12 Sep 2006
Bacterial Infections	China	Pfizer Inc.	12 Sep 2006
Burn infections	Japan	Pfizer Japan, Inc.	20 Apr 2006
Methicillin-Resistant Staphylococcus Epidermidis (MRSE) Infection	Japan	Pfizer Japan, Inc.	20 Apr 2006
Pneumonia, Staphylococcal	Japan	Pfizer Japan, Inc.	20 Apr 2006
Pyoderma	Japan	Pfizer Japan, Inc.	20 Apr 2006
Staphylococcal Skin Infections	Japan	Pfizer Japan, Inc.	20 Apr 2006
Cross Infection	Hong Kong	Pfizer Inc.	31 Oct 2004
Cross Infection	Taiwan Province	Pfizer Inc.	31 Oct 2004
Diabetic Foot	United States	Pfizer Inc.	31 Jul 2003
Staphylococcal Infections	Japan	Pfizer Japan, Inc.	04 Apr 2001
Community Acquired Pneumonia	United States	Pfizer Inc.	18 Apr 2000
Complicated skin and skin structure infection	United States	Pfizer Inc.	18 Apr 2000
Hospital-acquired pneumonia	United States	Pfizer Inc.	18 Apr 2000
Infectious Diseases	United States	Pfizer Inc.	18 Apr 2000
Non-complicated skin and skin structure infection	United States	Pfizer Inc.	18 Apr 2000

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Skin Diseases, Bacterial	Phase 3	-	Cubist Pharmaceuticals LLC	25 Mar 2015
Extensively Drug-Resistant Tuberculosis	Phase 3	South Africa	Global Alliance for TB Drug Development	01 Mar 2015
Infectious Lung Disorder	Phase 3	South Africa	Global Alliance for TB Drug Development	01 Mar 2015
Pulmonary Tuberculosis	Phase 3	South Africa	Global Alliance for TB Drug Development	01 Mar 2015
Optic Nerve Diseases	Phase 3	United States	Pfizer Inc.	01 Nov 2008
Optic Nerve Diseases	Phase 3	Italy	Pfizer Inc.	01 Nov 2008
Optic Nerve Diseases	Phase 3	Sweden	Pfizer Inc.	01 Nov 2008
MRSA - Methicillin resistant Staphylococcus aureus infection	Phase 3	Japan	Pfizer Inc.	01 Jan 2003
Catheter-Related Infections	Phase 3	-	Pfizer Inc.	01 Apr 2002
Febrile Neutropenia	Phase 3	United States	Pfizer Inc.	01 Nov 2001

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00664313 (LiMiT, CTgov)	Phase 1/2	Extensively Drug-Resistant Tuberculosis	36	Linezolid (Linezolid)	ubdlpiuvfq = ywdkyaslxf ztyjvpsjgn (xwgkmctrxp, wnvhnbfpys - byomijmbsv) View more	-	06 Jul 2026
				Placebo (Placebo)	ubdlpiuvfq = ejkyjausuq ztyjvpsjgn (xwgkmctrxp, mdnujalskz - dsbjqaebtl) View more
NCT06058299 (CTgov)	Phase 2	Pulmonary Tuberculosis	309	TBAJ876 (TBAJ876 25 mg)	nmkmpzrpde(rnvbsysanf) = vydjcmacgy kfsesotrjg (ggehmhhfcq, vcbtpnfoti - webednxglu)	-	24 Jun 2026
				TBAJ876 (TBAJ876 50 mg)	nmkmpzrpde(rnvbsysanf) = nfwntizlgk kfsesotrjg (ggehmhhfcq, ryhrscmpph - gcxtnimkqy)
NCT05156437 (OPTIMAL, CTgov)	Phase 4	Endocarditis	5	Cefalexin+Levofloxacin+Amoxycillin+Oxacillin+Ceftriaxone+Dicloxacillin+Rifampicin+Ampicillin+Linezolid+Daptomycin+Vancomycin (Group I (Experimental))	jamwkvsuve(nswaexzelr) = khtrgrqaxj clsxcurclu (qgjzfutcib, rkaqdxbliq - gtpojjkwua) View more	-	05 May 2026
				Oxacillin+Ceftriaxone+Ampicillin+Daptomycin+Vancomycin (Group II (Control Group))	jamwkvsuve(nswaexzelr) = csmxdhewts clsxcurclu (qgjzfutcib, rvlddzztmy - ioonurkyvr) View more
NCT05007821 (CTgov)	Phase 2	Multidrug resistant pulmonary tuberculosis \| Tuberculosis, Multidrug-Resistant	138	Linezolid 600 mg+Bedaquiline 200 mg+Clofazimine 100 mg+Delamanid 300 mg (Arm A)	crppezvtrt(ggnplgrqcu) = umnbiecfro jieuliapkc (uisgfybzid, bcmzwhjwau - khnycthbpf) View more	-	01 May 2026
				Linezolid+Bedaquiline 200 mg+Clofazimine 100 mg+Delamanid 300 mg (Arm B)	crppezvtrt(ggnplgrqcu) = czhbalogax jieuliapkc (uisgfybzid, jcbbfhotvc - smjcfbuski) View more
NCT04238676 (Persica 002, CTgov)	Phase 1/2	Low Back Pain \| Edema	43	PP353	acmahfhrul = yyiepyhfik dpbfhssfgq (xdubqenfqm, pmbjkyqnio - duzhnoistf) View more	-	27 Mar 2026
NCT04238676 (Pubmed \| EClinicalMedicine)	Phase 1	-	40	PP353 (2 intradiscal doses)	jqyxoktest(vqdhxtyadp) = erszzduumh uzhjxwqqhg (ckiytbffae )	Positive	01 Feb 2026
				Placebo (2 sham procedures)	jqyxoktest(vqdhxtyadp) = diyasnedcv uzhjxwqqhg (ckiytbffae )
NCT05977868 (COPAT, CTgov)	Phase 4	Bone and joint infections \| Genitourinary tract infection \| Infection of digestive system ... View more	94	cefalexin+levofloxacin+Amoxicillin+doxycycline+delafloxacin+amoxicillin-clavulanate+linezolid+ciprofloxacin+cefpodoxime+cefadroxil (Group 1 (Experimental))	fagobmhppe = dkbkktfslj wzqwldqaah (fsjmkfimwl, kbyygcymrv - dboemkgbuz) View more	-	26 Aug 2025
				cefazolin+ceftazidime-avibactam+dalbavancin+ampicillin-sulbactam+ceftaroline+ceftazidime+Ampicillin+cefepime+daptomycin+ertapenem (Group 2 (Control))	fagobmhppe = ywgkclzktd wzqwldqaah (fsjmkfimwl, ayqoaigtrg - ialmughcut) View more
NCT03474198 (TRUNCATE-TB, Pubmed \| Lancet Infect Dis)	Phase 2/3	Pulmonary Tuberculosis	675	Standard Treatment (rifampicin, isoniazid, pyrazinamide, and ethambutol)	ezoxjuvtsb(yigvykfmqp) = fwtnowmhal bowrwkijoz (wdboxvaqcw ) View more	Negative	01 May 2025
				High-dose rifampicin and linezolid	ezoxjuvtsb(yigvykfmqp) = oqugqkoywd bowrwkijoz (wdboxvaqcw ) View more
NCT04238676 (GlobeNewswire) Manual	Phase 1	Low Back Pain	44	PP353	aqhaplhqfb(nwwtwzqksc) = dfxdeqqyow foczgvzswz (zugynwqghn ) Met View more	Positive	05 Mar 2025
				Placebo	aqhaplhqfb(nwwtwzqksc) = ffqnutrvqk foczgvzswz (zugynwqghn ) Met View more
NCT02619994 (MDR-END, CTgov)	Phase 2	Tuberculosis, Multidrug-Resistant	214	Locally-used WHO-approved MDR-TB regimen in Korea (Control Arm)	uvylhtbjiu = krjqlkpvlp dwbsgluruk (ojulruvvxs, brswxzdaan - mzuekmfkir) View more	-	03 Jan 2025
				levofloxacin+Linezolid+Delamanid+Pyrazinamide (Experimental Arm)	uvylhtbjiu = lnivztqqpn dwbsgluruk (ojulruvvxs, cpszayikid - cuwdehtcag) View more

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