Single-Dose IV Oritavancin Diphosphate

Melinta Therapeutics, Inc. · Phase 3 active Small molecule

Single-Dose IV Oritavancin Diphosphate is a Lipoglycopeptide antibiotic Small molecule drug developed by Melinta Therapeutics, Inc.. It is currently in Phase 3 development for Acute bacterial skin and skin structure infections (ABSSSI). Also known as: Oritavancin Diphosphate.

Oritavancin diphosphate is a lipoglycopeptide antibiotic that inhibits cell wall synthesis in Gram-positive bacteria.

Oritavancin diphosphate is a lipoglycopeptide antibiotic that inhibits cell wall synthesis in Gram-positive bacteria. Used for Acute bacterial skin and skin structure infections (ABSSSI).

Likelihood of approval

60.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

• Baseline phase 3 → approval rate +58.3pp
  Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
• Anti-infectives pathway favourability +2.0pp
  Microbiological endpoints + non-inferiority designs raise approval rates above baseline.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Single-Dose IV Oritavancin Diphosphate
Also known as	Oritavancin Diphosphate
Sponsor	Melinta Therapeutics, Inc.
Drug class	Lipoglycopeptide antibiotic
Target	Lipid II
Modality	Small molecule
Therapeutic area	Infectious Diseases
Phase	Phase 3

Mechanism of action

Oritavancin diphosphate binds to the cell wall precursor lipid II, preventing the incorporation of D-alanyl-D-alanine into the cell wall, ultimately leading to cell lysis and death. This mechanism of action is specific to Gram-positive bacteria, making it effective against a range of pathogens, including MRSA.

Approved indications

• Acute bacterial skin and skin structure infections (ABSSSI)

Common side effects

• Nausea
• Vomiting
• Headache
• Infusion site reaction

Key clinical trials

• Open Label, Dose-finding, Pharmacokinetics, Safety and Tolerability Study of Oritavancin in Pediatric Participants With Suspected or Confirmed Bacterial Infections (PHASE1)
• A Study to Assess the Cardiac Safety of Oritavancin in Healthy Participants (PHASE1)
• Open Label Study Evaluating the Effects of a Single Oritavancin Infusion on Cytochrome P450 in Healthy Volunteers (PHASE1)
• Drug-Drug Interaction Potential of Orbactiv (Oritavancin) Co-Administered With Warfarin in Healthy Subjects (PHASE1)
• Oritavancin Versus IV Vancomycin for the Treatment of Participants With Acute Bacterial Skin and Skin Structure Infection (SOLO I) (PHASE3)
• Oritavancin Versus IV Vancomycin for the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infection (PHASE3)
• Relative Exposure and Safety Study of Kimyrsa in ABSSSI Patients (PHASE1)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Single-Dose IV Oritavancin Diphosphate CI brief — competitive landscape report
• Single-Dose IV Oritavancin Diphosphate updates RSS · CI watch RSS
• Melinta Therapeutics, Inc. portfolio CI

Frequently asked questions about Single-Dose IV Oritavancin Diphosphate

What is Single-Dose IV Oritavancin Diphosphate?

Single-Dose IV Oritavancin Diphosphate is a Lipoglycopeptide antibiotic drug developed by Melinta Therapeutics, Inc., indicated for Acute bacterial skin and skin structure infections (ABSSSI).

How does Single-Dose IV Oritavancin Diphosphate work?

Oritavancin diphosphate is a lipoglycopeptide antibiotic that inhibits cell wall synthesis in Gram-positive bacteria.

What is Single-Dose IV Oritavancin Diphosphate used for?

Single-Dose IV Oritavancin Diphosphate is indicated for Acute bacterial skin and skin structure infections (ABSSSI).

Who makes Single-Dose IV Oritavancin Diphosphate?

Single-Dose IV Oritavancin Diphosphate is developed by Melinta Therapeutics, Inc. (see full Melinta Therapeutics, Inc. pipeline at /company/melinta-therapeutics-inc).

Is Single-Dose IV Oritavancin Diphosphate also known as anything else?

Single-Dose IV Oritavancin Diphosphate is also known as Oritavancin Diphosphate.

What drug class is Single-Dose IV Oritavancin Diphosphate in?

Single-Dose IV Oritavancin Diphosphate belongs to the Lipoglycopeptide antibiotic class. See all Lipoglycopeptide antibiotic drugs at /class/lipoglycopeptide-antibiotic.

What development phase is Single-Dose IV Oritavancin Diphosphate in?

Single-Dose IV Oritavancin Diphosphate is in Phase 3.

What are the side effects of Single-Dose IV Oritavancin Diphosphate?

Common side effects of Single-Dose IV Oritavancin Diphosphate include Nausea, Vomiting, Headache, Infusion site reaction.

What does Single-Dose IV Oritavancin Diphosphate target?

Single-Dose IV Oritavancin Diphosphate targets Lipid II and is a Lipoglycopeptide antibiotic.

Related

• Drug class: All Lipoglycopeptide antibiotic drugs
• Target: All drugs targeting Lipid II
• Manufacturer: Melinta Therapeutics, Inc. — full pipeline
• Therapeutic area: All drugs in Infectious Diseases
• Indication: Drugs for Acute bacterial skin and skin structure infections (ABSSSI)
• Also known as: Oritavancin Diphosphate