The study aimed to conduct a randomized, non-inferiority controlled trial to compare the short- and medium-term efficacy and safety of two antibiotic dosage regimens in cardiac implantable electronic devices (CIED) infections with multidrug-resistant Gram-positive cocci: 1) single-dose therapy with a long-half-life antibiotic (oritavancin) vs. standard 7-14 days of therapy with a short-half-life antibiotic (vancomycin) for CIED surgical incision site or pocket infection; and 2) fractionated therapy with a long-half-life antibiotic (oritavancin) at seven-day intervals compared to standard therapy with a short-half-life antibiotic (vancomycin) fractionated in 2-3 daily doses in cases of lead-related infectious endocarditis.

Start Date01 Jun 2025

Sponsor / Collaborator

Medical University of Silesia

[+1]

NCT05521880

/ TerminatedPhase 4IIT

Anchoring Intermittent Long Acting Antimicrobials to Medication for Opioid Use Disorder Treatment to Facilitate Structured Transitions of Care for People Who Use Drugs Admitted to the Hospital With Invasive Infections

Standard of care for patients with opioid use disorder and complicated infections is discharge to subacute nursing facilities on IV antibiotics until completion of treatment course. We aim to determine the efficacy of an alternative strategy using intermittent outpatient oritavancin therapy dosed weekly combined with initiation and continuation of medication assisted treatment for opioid use disorder for completion of antimicrobial therapy in a 12 week prospective, open-label study. Patients hospitalized for a drug use related infection and thought to need prolonged parenteral antimicrobial therapy will be assessed by a substance use consultant and Infectious Diseases service. If they are not on Medication for Opioid Use Disorder (MOUD), they will be assessed for initiation of MOUD. A collaborative multidisciplinary discharge planning process will be initiated and will involve linkage to care. If they have an infection with a gram positive organism, and are thought to be clinically stable for hospital discharge, they will be assessed for appropriateness for oritavancin and first dose will be administered prior to discharge. They will have an intake into an opioid treatment program where they can access collocated services and will be discharged with linkage to care through a peer recovery coach. They will be assessed in this collocated clinic post discharge for optimization of MOUD and progress of infection and subsequent dose/s of oritavancin will be administered. Patients will be followed for 12 weeks for cure/completion of therapy and MOUD outcomes.

Start Date15 Jul 2024

Sponsor / Collaborator

University of Maryland Baltimore

NCT05599295

/ CompletedPhase 2

A Multicenter, Open-Label, Evaluator-Blinded, Randomized Study to Evaluate the Safety and Tolerability of Single-Dose Intravenous Oritavancin for the Treatment of Pediatric Subjects With Acute Bacterial Skin and Skin Structure Infections

This protocol describes a randomized, open-label study to evaluate the safety and tolerability of 2 formulations of single-dose intravenous (IV) oritavancin diphosphate (Orbactiv and Kimyrsa) for the treatment of pediatric participants with acute bacterial skin and skin structure infections (ABSSSIs).
This study involves 2 oritavancin products, Orbactiv and Kimyrsa. Oritavancin is the active drug substance in both Orbactiv and Kimyrsa. This study protocol distinguishes the differences between Orbactiv and Kimyrsa by providing product-specific data, and information and guidance for Investigators. "Oritavancin" is used to describe drug product data and information and guidance that is not specific to Orbactiv or Kimyrsa (that is, applies to both).
The study involves pharmacokinetic sampling and will evaluate clinical outcome assessments. The study was designed to capture adequate data while minimizing the impact to participants and their caregivers.

Start Date15 Jun 2023

Sponsor / Collaborator

Melinta Therapeutics, Inc.

100 Clinical Results associated with Oritavancin Diphosphate

100 Translational Medicine associated with Oritavancin Diphosphate

100 Patents (Medical) associated with Oritavancin Diphosphate

366

Literatures (Medical) associated with Oritavancin Diphosphate

01 Apr 2026·BIOCHIMICA ET BIOPHYSICA ACTA-BIOMEMBRANES

Mechanistic insight into the role of lipoglycopeptide drugs in hepatotoxicity

Article

Author: Subramaniyan, Vetriselvan ; Kumar, Ashutosh ; Saha, Arabinda ; Gupta, Raj ; Jha, Akash Kumar

Understanding how antibiotics interact with membranes is crucial for predicting their off-target effects, particularly hepatotoxicity. This work compares two clinically important glycopeptide antibiotics, Teicoplanin and Oritavancin, using an integrative approach that combines in vivo pathology, lipid biophysics, drug-lipid interactions by NMR spectroscopy, and molecular dynamics simulations. Despite causing little direct disruption to lipid membranes, Teicoplanin produced significant hepatotoxicity, including increased liver enzymes and histopathological loss. Teicoplanin localises at the membrane-aqueous interface, where it forms stable surface-level interactions that have the potential to periodically disrupt membrane-associated processes. On the other hand, due to its deep insertion into the bilayer core, Oritavancin exhibited a more benign hepatic profile, despite causing stronger membrane perturbation. Long-term cellular stress is probably mitigated by this embedded configuration, which facilitates less interaction with membrane receptors. These findings demonstrate that glycopeptide-induced hepatotoxicity is governed by the topology and duration of membrane interactions rather than simply by their magnitude. The study promotes a lipid-centric framework for the logical development of safer, membrane-active treatments and emphasises the value of lipid membrane models and atomistic simulations as predictive tools in early-stage drug evaluation.

19 Jan 2026·JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY

Long-acting glycopeptides: what are the barriers to access in patients who need them most, and how can they be overcome?

Article

Author: MacPhail, Aleece ; Attwood, Lucy O ; Rogers, Benjamin A

Abstract:

Long-acting glycopeptide antibiotics (LGPs), such as dalbavancin and oritavancin, are a novel class of antibiotic agents effective in the treatment of Gram-positive infections. The long half-life and relative ease of administration of LGPs make them a valuable treatment option for patients experiencing barriers to healthcare access. However, challenges for effective use remain, and disproportionately affect patients who would most benefit. These include high upfront costs, cost siloing, impractical and inconsistent medication approval processes and limited integration into existing multidisciplinary models of care. There is a clear need to improve funding arrangements, institutional workflows and models of care to promote safe and equitable access to LGPs, in line with processes developed for other high-cost medications.

01 Dec 2025·INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES

Medical source control with oritavancin in complicated gram-positive bacterial infections: A case series

Article

Author: Scabini, Silvia ; De Rosa, Francesco Giuseppe ; Corcione, Silvia ; De Benedetto, Ilaria ; Marena, Saverio ; Lupia, Tommaso ; Molino, Francesca ; Canta, Francesca ; Curtoni, Antonio ; Fornari, Valentina ; Viglianti, Rita ; Pinna, Simone Mornese

OBJECTIVES:

This retrospective observational case series describes a population with complicated gram-positive infections treated with oritavancin as part of a highly individualized strategy.

DESIGN/METHODS:

We conducted a retrospective observational case series of 10 patients with complicated gram-positive infections treated with oritavancin at a tertiary care center.

RESULTS:

Most patients had multiple comorbidities and previous antibiotic toxicities. Oritavancin was well tolerated, with no reported adverse events. All patients achieved clinical cure, and no relapses were observed during a follow-up of up to 24 months.

CONCLUSIONS:

These findings suggest it may serve as an effective medical alternative to source control in frail, difficult-to-treat populations.

News (Medical) associated with Oritavancin Diphosphate

02 Feb 2026

·cormedix.com

CORMEDIX THERAPEUTICS ANNOUNCES SHARE REPURCHASE PROGRAM

Berkeley Heights, NJ – February 2, 2026 – CorMedix Therapeutics (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced its Board of Directors has approved a share repurchase program, which authorizes the Company to repurchase up to $75 million of the Company’s outstanding common stock. The repurchase program is authorized through December 31, 2027. “With a strong balance sheet, solid operating performance, and expected ongoing cash flow generation, we believe we are well positioned to execute this share repurchase program while continuing to advance our growth strategy,” said Joseph Todisco, Chairman & CEO of CorMedix Therapeutics. “The program provides a disciplined way to return value to shareholders while preserving the financial flexibility to invest in our business, including potential inorganic opportunities. We remain confident in our long-term outlook and in the potential of our late-stage clinical programs to deliver meaningful benefits for patients.” CorMedix expects to begin repurchasing shares as early as Q1 2026 and had approximately $150 million in cash and cash equivalents, and 79.3 million common shares outstanding as of December 31, 2025. Repurchases may be made at management’s discretion from time to time in privately negotiated transactions, through block trades, pursuant to open market purchases or pursuant to trading plans as permitted under applicable securities laws. In addition, any repurchases under the authorization will be subject to prevailing market conditions, liquidity and cash flow considerations, applicable securities laws and regulations, and other factors. The share repurchase program does not require CorMedix Therapeutics to acquire any amount of shares, and may be suspended or discontinued at any time. About CorMedix CorMedix Therapeutics is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. CorMedix is commercializing DefenCath® (taurolidine and heparin) for the prevention of catheter-related bloodstream infections in adult patients undergoing hemodialysis via a central venous catheter. Following its August 2025 acquisition of Melinta Therapeutics LLC, CorMedix is also commercializing a portfolio of anti-infective products, including MINOCIN® (minocycline) for Injection, REZZAYO® (rezafungin for injection), VABOMERE® (meropenem and vaborbactam), ORBACTIV™ (oritavancin), BAXDELA® (delafloxacin), and KIMYRSA® (oritavancin), as well as TOPROL-XL® (metoprolol succinate). CorMedix has ongoing clinical studies for DefenCath in Total Parenteral Nutrition (TPN) and Pediatric Hemodialysis populations and also intends to develop DefenCath as a catheter lock solution for use in other patient populations. REZZAYO is currently approved for the treatment of candidemia and invasive candidiasis in adults, with an ongoing Phase III study for the prophylaxis of IFD in adult patients undergoing allogeneic BMT. Topline results of the Phase III study for REZZAYO are expected in Q2 2026. For more information visit: www.cormedix.com or www.melinta.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are subject to risks and uncertainties. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements including, but not limited to statements regarding financial and operating results, cash flow, shareholder return, outlook of the business, expectations regarding timing, execution and impact of the share repurchase program, expectations and timing regarding clinical studies and development and expectations of CorMedix’s product pipeline, expectations regarding implementation and perceived benefits of CorMedix’s products. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its most recent Annual Report on Form 10-K, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. Investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law. Investor Contact: Dan Ferry Managing Director LifeSci Advisors daniel@lifesciadvisors.com (617) 430-7576

Phase 3AcquisitionDrug Approval

02 Feb 2026

·www.biospace.com

CorMedix Therapeutics Announces Share Repurchase Program

BERKELEY HEIGHTS, N.J., Feb. 02, 2026 (GLOBE NEWSWIRE) -- CorMedix Therapeutics (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced its Board of Directors has approved a share repurchase program, which authorizes the Company to repurchase up to $75 million of the Company’s outstanding common stock. The repurchase program is authorized through December 31, 2027. “With a strong balance sheet, solid operating performance, and expected ongoing cash flow generation, we believe we are well positioned to execute this share repurchase program while continuing to advance our growth strategy,” said Joseph Todisco, Chairman & CEO of CorMedix Therapeutics. “The program provides a disciplined way to return value to shareholders while preserving the financial flexibility to invest in our business, including potential inorganic opportunities. We remain confident in our long-term outlook and in the potential of our late-stage clinical programs to deliver meaningful benefits for patients.” CorMedix expects to begin repurchasing shares as early as Q1 2026 and had approximately $150 million in cash and cash equivalents, and 79.3 million common shares outstanding as of December 31, 2025. Repurchases may be made at management’s discretion from time to time in privately negotiated transactions, through block trades, pursuant to open market purchases or pursuant to trading plans as permitted under applicable securities laws. In addition, any repurchases under the authorization will be subject to prevailing market conditions, liquidity and cash flow considerations, applicable securities laws and regulations, and other factors. The share repurchase program does not require CorMedix Therapeutics to acquire any amount of shares, and may be suspended or discontinued at any time. About CorMedix CorMedix Therapeutics is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. CorMedix is commercializing DefenCath ® (taurolidine and heparin) for the prevention of catheter-related bloodstream infections in adult patients undergoing hemodialysis via a central venous catheter. Following its August 2025 acquisition of Melinta Therapeutics LLC, CorMedix is also commercializing a portfolio of anti-infective products, including MINOCIN ® (minocycline) for Injection, REZZAYO ® (rezafungin for injection), VABOMERE ® (meropenem and vaborbactam), ORBACTIV ™ (oritavancin), BAXDELA ® (delafloxacin), and KIMYRSA ® (oritavancin), as well as TOPROL-XL ® (metoprolol succinate). CorMedix has ongoing clinical studies for DefenCath in Total Parenteral Nutrition (TPN) and Pediatric Hemodialysis populations and also intends to develop DefenCath as a catheter lock solution for use in other patient populations. REZZAYO is currently approved for the treatment of candidemia and invasive candidiasis in adults, with an ongoing Phase III study for the prophylaxis of IFD in adult patients undergoing allogeneic BMT. Topline results of the Phase III study for REZZAYO are expected in Q2 2026. For more information visit: or . Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are subject to risks and uncertainties. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements including, but not limited to statements regarding financial and operating results, cash flow, shareholder return, outlook of the business, expectations regarding timing, execution and impact of the share repurchase program, expectations and timing regarding clinical studies and development and expectations of CorMedix’s product pipeline, expectations regarding implementation and perceived benefits of CorMedix’s products. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its most recent Annual Report on Form 10-K, copies of which are available free of charge at the SEC’s website at or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. Investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law. Investor Contact: Dan Ferry Managing Director LifeSci Advisors daniel@lifesciadvisors.com (617) 430-7576

Phase 3AcquisitionDrug Approval

08 Jan 2026

·www.biospace.com

CorMedix Therapeutics Announces Preliminary Fourth Quarter and Full Year 2025 Results and Provides Business Updates

‒ Q4 2025 Unaudited Net Revenue of Approximately $127 million ‒ ‒ FY 2025 Unaudited Pro Forma Net Revenue of Approximately $400 million ‒ ‒ Expects Q4 Adjusted EBITDA of Between $77 million and $81 million ‒ ‒ Unaudited Cash and Short-term Investments of Approximately $148 million ‒ BERKELEY HEIGHTS, N.J., Jan. 08, 2026 (GLOBE NEWSWIRE) -- CorMedix Therapeutics (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announces its preliminary unaudited fourth quarter 2025 and full-year 2025 results, and provides guidance and an update on its business. These include the following key updates: CorMedix announces preliminary, unaudited financial results for Q4 and FY 2025, including net revenue of approximately $127 million and $310 million, for Q4 2025 and FY 2025, respectively, FY 2025 Pro Forma net revenue (1) of approximately $400 million, and Q4 2025 adjusted EBITDA ( 2 ) in the range of $77 million to $81 million. The Company reports preliminary unaudited cash and short-term investments, as of December 31, 2025, of approximately $148 million. CorMedix expects clinical data from the Phase 3 ReSPECT study of REZZAYO® (rezafungin for injection) in the prophylaxis of invasive fungal infection in adult patients undergoing allogeneic blood and marrow transplant in Q2 2026. In addition, the ongoing Phase 3 study of taurolidine/heparin catheter lock solution in TPN patients continues to enroll patients with targeted completion in early 2027. The Company continues to see strong utilization and patient growth for DefenCath® (taurolidine and heparin) by its outpatient dialysis organization customers. On July 1, 2026, DefenCath’s TDAPA reimbursement transitions into a post-TDAPA Add-On Adjustment, the calculation of which is determined by CMS. As a result of the methodology utilized by CMS, the level of reimbursement provided to institutions treating dialysis patients will significantly decline, and as a result, CorMedix expects a corresponding reduction to its net pricing for DefenCath in Q3 and Q4 of 2026. If CMS utilizes the same methodology to calculate the 2027 post-TDAPA Add-On Adjustment, which will be effective on January 1, 2027, CorMedix estimates the value of the Add-On Adjustment will be 3x – 5x higher than that granted for Q3 and Q4 of 2026, which the Company expects would result in higher DefenCath sales prices in 2027 relative to H2 2026. CorMedix is introducing FY 2026 Revenue guidance of $300 million to $320 million, which includes $150 million to $170 million for DefenCath. 2026 DefenCath revenue guidance is heavily weighted toward H1 2026 and assumes modest utilization growth, which the Company expects will offset some of the price erosion over the course of the year. Based on the assumption of a higher net selling price in 2027 relative to H2 2026, the Company currently estimates full-year 2027 DefenCath sales in the range of $100 million to $140 million. DefenCath guidance for 2026 and 2027 assumes the maintenance of its current outpatient dialysis utilization run-rate with existing customers, and excludes any potential upside from new outpatient dialysis customers, increased utilization due to anticipated Medicare Advantage contracting, or any change in reimbursement due to pending TDAPA legislation. In addition, management has operationalized synergies of approximately $35 million, on a full-year run rate basis, related to the acquisition of Melinta and is now focused on driving growth strategies for the business. The Company is estimating FY 2026 operating expenses of $145 million to $160 million, excluding non-cash items and one-time expenses, with the upper end of the spending range contingent upon positive Phase 3 data related to the ReSPECT study and a potential acceleration of enrollment in the DefenCath TPN study. Based on these estimates, CorMedix estimates FY 2026 Adjusted EBITDA in the range of $100 million to $125 million. CorMedix is excited to announce that it will hold an Analyst Day on February 10, 2026, during which it will provide significant background on the medical need and the market potential for its key pipeline assets of REZZAYO in prophylaxis and DefenCath in TPN, as well as insights on the future strategic direction for the business. Details will be forthcoming. Joseph Todisco, CorMedix Therapeutics CEO, commented, “I’m proud to announce our preliminary Q4 and FY 2025 results today, including surpassing our guidance for 2025. 2025 was a transformational year for CorMedix, as we evolved beyond a single-product company to an organization with multiple growth drivers and pipeline assets. We closed 2025 in a strong cash position, which we expect to further bolster over the coming year, providing the Company with financial flexibility to drive value for shareholders. With our new leadership team in place and multiple near-term pipeline catalysts, I am excited about the long-term potential for CorMedix Therapeutics.” The preliminary financial information presented in this press release is based on CorMedix’s current expectations and may be adjusted as a result of, among other things, the completion of our internal review process and the completion of customary annual audit procedures. (1) FY 2025 Unaudited Pro Forma Net Revenue was prepared by combining the estimated financial results and for CorMedix and Melinta for the full fiscal year ended December 31, 2025, without further adjustment, as if the transaction had closed on January 1, 2025. (2) Adjusted EBITDA is a non-GAAP financial measure and excludes non-cash items such as depreciation, amortization and stock-based compensation, and certain non-recurring items. The Company expects to provide a reconciliation of Adjusted EBITDA to the most comparable GAAP measure in its earnings release relating to the fourth quarter and full year 2025 financial results. Such reconciliation is not included in this release because CorMedix is currently finalizing certain amounts that would be required to be included in the U.S. GAAP measure or the individual adjustments for such reconciliation. About CorMedix CorMedix Therapeutics is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. CorMedix is commercializing DefenCath ® (taurolidine and heparin) for the prevention of catheter-related bloodstream infections in adult patients undergoing hemodialysis via a central venous catheter. Following its August 2025 acquisition of Melinta Therapeutics LLC, CorMedix is also commercializing a portfolio of anti-infective products, including MINOCIN ® (minocycline) for Injection, REZZAYO ® (rezafungin), VABOMERE ® (meropenem and vaborbactam), ORBACTIV ™ (oritavancin), BAXDELA ® (delafloxacin), and KIMYRSA ® (oritavancin), as well as TOPROL-XL ® (metoprolol succinate). CorMedix has ongoing clinical studies for DefenCath in Total Parenteral Nutrition (TPN) and Pediatric Hemodialysis populations and also intends to develop DefenCath as a catheter lock solution for use in other patient populations. REZZAYO is currently approved for the treatment of candidemia and invasive candidiasis in adults, with an ongoing Phase III study for the prophylaxis of IFD in adult patients undergoing allogeneic BMT. Topline results of the Phase III study for REZZAYO are expected in Q2 2026. For more information visit: or . Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act, and Section 21E of the Exchange, as amended (the “Exchange Act”), that are subject to risks and uncertainties. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “will,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements including, but not limited to statements regarding financial guidance, sales, revenue and operating expense estimates, expectations regarding product utilization, product reimbursement rates, synergy estimates and timing, expectations and timing regarding clinical studies and development and expectations of CorMedix’s product pipeline, results of the real-world study, expectations regarding implementation and perceived benefits of CorMedix’s products. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its most recent Annual Report on Form 10-K, copies of which are available free of charge at the SEC’s website at or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. Investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law. Investor Contact: Dan Ferry Managing Director LifeSci Advisors daniel@lifesciadvisors.com (617) 430-7576

Phase 3AcquisitionDrug ApprovalFinancial Statement

100 Deals associated with Oritavancin Diphosphate

External Link

KEGG	Wiki	ATC	Drug Bank
D05271	Oritavancin Diphosphate	J01XA05	DB04911

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Skin and skin structure infections	United States	Melinta Therapeutics, Inc.	06 Aug 2014

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Bacterial Infections	NDA/BLA	Canada	Xediton Pharmaceuticals, Inc.	01 Aug 2024
Staphylococcal Skin Infections	Phase 3	United Kingdom	The Medicines Co.	08 Feb 2011
Subcutaneous Abscess	Phase 3	United Kingdom	The Medicines Co.	08 Feb 2011
Abscess	Phase 3	United States	Melinta Therapeutics, Inc.	01 Dec 2010
Cellulitis	Phase 3	United States	Melinta Therapeutics, Inc.	01 Dec 2010
Wound Infection	Phase 3	United States	Melinta Therapeutics, Inc.	01 Dec 2010
Erysipelas	Phase 2	United States	Melinta Therapeutics, Inc.	15 Jun 2023
Erysipelas	Phase 2	Bulgaria	Melinta Therapeutics, Inc.	15 Jun 2023
Erysipelas	Phase 2	Greece	Melinta Therapeutics, Inc.	15 Jun 2023
Erysipelas	Phase 2	Latvia	Melinta Therapeutics, Inc.	15 Jun 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02925416 (CTgov)	Phase 4	Skin Diseases, Bacterial \| Erysipelas	22	Oritavancin (Oritavancin/Oritavancin)	zcsgewytip = iftattdlvy gwovelkzmz (uhczrhodcu, nrmftqzgou - wugcjwezig) View more	-	01 Feb 2024
				Placebo (D5W)+Oritavancin (Oritavancin/Placebo)	zcsgewytip = sxfusshcwq gwovelkzmz (uhczrhodcu, hrinkapctq - nbwkqoraoa) View more
NCT02452918 (CTgov)	Phase 4	Skin and skin structure infections \| Erysipelas \| Cellulitis	17	Oritavancin (Oritavancin 1200 mg Without Concomitant Warfarin Therapy)	hvizzbnvpe = tcxqfsgerm qeiducgymr (kstbzmvgcp, klpbamxkrm - mczkodqboy) View more	-	20 Dec 2023
				Warfarin+Oritavancin (Oritavancin 1200 mg With Concomitant Warfarin Therapy)	hvizzbnvpe = nbduyvagjx qeiducgymr (kstbzmvgcp, egmwswwkxw - ocnzzzdfxk) View more
NCT01252719 (SOLO I and SOLO II \| SOLO I, CTgov)	Phase 3	Abscess \| Cellulitis \| Wound Infection	968	Oritavancin (Single-Dose 1200 mg Oritavancin)	wcshffndtd = vpykjjfpqj ajipqkwjbf (qoszcdofwg, abyacybpkf - ylmcwvkzfe) View more	-	01 Aug 2022
				Vancomycin (Vancomycin)	wcshffndtd = tybhjasstq ajipqkwjbf (qoszcdofwg, jqhsgzrhny - nwbrbfxqec) View more
NCT03873987 (CTgov)	Phase 1	Skin and skin structure infections \| Erysipelas \| Cellulitis	102	Kimyrsa	dtlimkelcm = pklhqxhrov aqjvgaaehg (nyojhsecew, psvszxgbtb - onqofzvpuz)	-	13 Apr 2021
NCT01252732 (SOLO I and SOLO II \| SOLO II, CTgov)	Phase 3	Abscess \| Cellulitis \| Wound Infection	1,019	Oritavancin (Single-Dose 1200 mg Oritavancin)	biyiyreaee = mfuddiiygr rmjowohnuy (kkecjovvst, aurozxqoge - gefsyahzik) View more	-	13 Apr 2021
				Vancomycin (Vancomycin)	biyiyreaee = xxedeerfly rmjowohnuy (kkecjovvst, dcphlrkjyi - omiskawxmx) View more
NCT01252719 \| NCT01252732 (SOLO II \| SOLO I, Pubmed) Manual	Phase 3	Skin and skin structure infections	792	Oritavancin	xkxmhkxjtn(dqhtblzgwk) = gytrkysywa rwdkbzyvvd (awltetcmhx ) View more	Positive	19 Jan 2017
				Vancomycin	xkxmhkxjtn(dqhtblzgwk) = gwrnitsuuc rwdkbzyvvd (awltetcmhx ) View more
NCT01252732 (SOLO II, Pubmed \| Clin Infect Dis) Manual	Phase 3	Gram-Positive Bacterial Infections	1,005	oritavancin	eqtbbfbyuy(ugvynakdmq) = zhgmdosmzt khdovijwzv (njasamqrxj ) View more	Non-inferior	15 Jan 2015
				vancomycin	eqtbbfbyuy(ugvynakdmq) = ofsbvkppsn khdovijwzv (njasamqrxj ) View more
NCT01252719 (SOLO I, Pubmed \| N Engl J Med)	Phase 3	Skin Diseases, Bacterial	475	Oritavancin 1200 mg	wzpoxbibri(tspqdnrrko) = nausea was more common among those treated with oritavancin qfwfjohyzh (donzbenqin )	Positive	05 Jun 2014
				Vancomycin
NCT00514527 (SIMPLIFI, Pubmed \| Antimicrob Agents Chemother)	Phase 2	Abscess \| Streptococcal Infections \| Skin and skin structure infections ... View more	302	Daily-dose group	ufuypjnjoi(neyqbncfio) = bjjyfwizvt elibedtaqv (elhyhyidgk ) View more	Positive	01 Jul 2011
				1,200-mg-single-dose group	ufuypjnjoi(neyqbncfio) = stfutdfvta elibedtaqv (elhyhyidgk ) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis