What Iterum Therapeutics does

Iterum Therapeutics plc was a clinical-stage and, briefly, commercial-stage pharmaceutical company incorporated in Ireland in 2015 and listed on NASDAQ (ticker ITRM) from May 2018 until its April 2026 delisting. The company developed sulopenem, a novel penem-class anti-infective, culminating in FDA approval of ORLYNVAH (sulopenem etzadroxil and probenecid) in October 2024 for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women with limited or no alternative oral antibacterial options. ORLYNVAH was the first and only oral penem antibiotic approved in the United States and the first new branded product for uUTIs in over 25 years. The underlying technology combines sulopenem etzadroxil with probenecid in a proprietary bilayer tablet designed to deliver potent activity against multidrug-resistant Enterobacterales, including ESBL- and AmpC-producing organisms. An IV formulation of sulopenem and a 510(k)-cleared sulopenem susceptibility test disc (manufactured by Liofilchem) rounded out the technology portfolio.

Iterum generated revenue through direct U.S. sales of ORLYNVAH following its August 2025 commercial launch, with an initial Q3 2025 net product revenue of $0.4 million and 2026 guidance of $5-15 million. The company deployed an outsourced go-to-market model, engaging EVERSANA Life Science Services for sales and commercial operations, McKesson and Cencora for specialty distribution, ACS Dobfar for manufacturing, and rebate agreements with the top three Medicare Part D PBMs providing access to roughly 60+ million insured lives. Target customers were prescribers (infectious disease physicians and community prescribers across seven launch states) treating adult women with resistant uUTIs, with a $25 copay savings program supporting patient access.

Despite regulatory approvals and broad payer coverage, Iterum failed to scale commercial revenue quickly enough to support operations. Following a $5 million registered direct offering in April 2025, a deferral of a $20 million Pfizer milestone obligation to October 2029, and continued cash burn against $11 million in cash as of September 30, 2025, the company filed a winding-up petition in the Irish High Court on March 27, 2026. Joint Provisional Liquidators from Teneo Restructuring were appointed, shares were suspended and delisted from Nasdaq on April 1, 2026, and the company announced plans to cease operations and withdraw ORLYNVAH from the U.S. market.

Name

Iterum Therapeutics

Legal name

Iterum Therapeutics plc

Website

https://iterumtx.com

Company type

Public

Founded year

2015

Operating status

Closed

Headcount range

1–10 employees

Short description

Iterum Therapeutics plc was a clinical-stage pharmaceutical company that developed and commercialized ORLYNVAH, the first FDA-approved oral penem antibiotic for uncomplicated urinary tract infections in adult women with resistant infections. The Irish-domiciled, NASDAQ-listed company filed for winding up in March 2026.

Ownership category

akta.pro rank

Product category

Anti-Infective Pharmaceuticals

NAICS

Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Infectious Disease & Antimicrobials Pharmaceuticals (HLAIAAAG)

Keywords

• Oral antibiotics
• Anti-infective therapeutics
• Penem antibiotics
• Urinary tract infection treatment
• Multi-drug resistant pathogens

Headquarters

HQ city

Dublin

HQ country

Ireland

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Technology or R&D, Marketing or Sales, Operations, Supply Chain

Revenue model

1. ORLYNVAH Product Sales: Iterum generates revenue through direct sales of its FDA-approved antibiotic ORLYNVAH (oral sulopenem) for the treatment of uncomplicated urinary tract infections. The product launched commercially in August 2025 with initial Q3 2025 revenue of $0.4 million. The company projects 2026 net product sales between $5 million and $15 million depending on uptake and payer coverage.

Pricing tiers

Go-to-market motion2 records

Distribution channels4 records

Marketing channels5 records

Core offering

Iterum Therapeutics develops and commercializes ORLYNVAH (sulopenem etzadroxil and probenecid), a novel oral penem antibiotic bilayer tablet approved by the FDA for treating uncomplicated urinary tract infections in adult women with limited or no alternative oral antibacterial treatment options. The company also holds patents and development assets around sulopenem, including IV formulations and a susceptibility test disc for laboratory use.

Product overview

Iterum Therapeutics is a clinical-stage pharmaceutical company that received FDA approval for its single commercial product, ORLYNVAH (sulopenem etzadroxil and probenecid), an oral penem antibiotic. The company also developed an IV formulation of sulopenem, though it remains unapproved. Both oral and IV formulations received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA in seven indications. The company commercialized ORLYNVAH through partnerships with EVERSANA for commercialization services, McKesson and Cencora for specialty distribution, and ACS Dobfar for manufacturing. The company filed for winding up in March 2026 and is in the process of dissolution.

Differentiator

Problem solved

Functional benefit

Brands

• ORLYNVAH: Novel oral penem antibiotic (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated urinary tract infections (uUTIs). The first and only oral penem antibiotic approved in the U.S.

Products and services

• ORLYNVAH (sulopenem etzadroxil and probenecid) Novel oral penem antibiotic combining sulopenem etzadroxil with probenecid in a bilayer tablet, FDA-approved (October 2024) for treating uncomplicated urinary tract infections in adult women with limited or no alternative oral antibacterial treatment options, with potent activity against ESBL- and AmpC-producing Enterobacterales.
• Sulopenem Antimicrobial Susceptibility Test Disc (2 µg)

Quantifiable outcome

• 57% of initial uncomplicated UTI infections were resistant to at least one antibiotic class; 13% were resistant to three or more
• +2 more outcomes

Named customers5 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration3 records

Feature2 records

Partnerships

Seven partnerships are on record, tiered core and minor.

• Teneo Restructuring (Ireland) LimitedcoreOthers · 27 March 2026Appointed as Joint Provisional Liquidators to Iterum Therapeutics plc and Iterum Therapeutics International Limited following High Court order in Ireland. Damien Murran and Jennifer McMahon overseeing company wind-down and dissolution process.
• ACS Dobfar S.p.AcoreImplementation/ SI/ Consulting Partner · 1 July 2025Commercial Manufacturing and Supply Agreement for the manufacture and supply of ORLYNVAH bilayer tablets for commercial supply purposes.
• EVERSANA Life Science Services, LLCcoreChannel Partner/ Reseller/ Distributor · 1 June 2025Product Commercialization Agreement for commercialization of ORLYNVAH in the U.S. EVERSANA provides sales and commercial operations services, marketing, logistics, channel management, regulatory, medical affairs and other services related to commercialization of ORLYNVAH in the United States.
• Pfizer Inc.coreOthersLicensor of sulopenem technology with license agreement requiring royalty payments. In May 2025, Pfizer agreed to extend the deferral term for payment of the $20.0 million regulatory milestone payment until October 25, 2029.
• McKessonminorChannel Partner/ Reseller/ DistributorSpecialty pharmacy distributor for ORLYNVAH allowing certain physicians to procure the product directly through McKesson specialty distribution channel.
• Cencora (formerly AmerisourceBergen)minorChannel Partner/ Reseller/ DistributorSpecialty pharmacy distributor for ORLYNVAH allowing certain physicians to procure the product directly through Cencora specialty distribution channel.
• Top three Medicare Part D Pharmacy Benefit ManagerscoreChannel Partner/ Reseller/ DistributorRebate agreements signed with top three Medicare Part D PBMs providing formulary coverage for ORLYNVAH. Initial agreements covered over 3.5 million lives, expanding to 10+ million lives with Medicare Advantage and Medicare Prescription Drug formularies.

Scale indicators7 records

Recent moves8 records

Expansion highlights5 records

Direct peers

• Spero Therapeutics: Spero is the closest direct competitor, developing oral antibiotics (including tebipenem HBr) for complicated uUTIs caused by resistant pathogens — the same anti-infective / AMR niche as ORLYNVAH.
• Melinta Therapeutics: Melinta is a focused anti-infectives company (Baxdela, Orbactiv, Kimyrsa, Minocin) with hospital-channel infrastructure, comparable in size and therapeutic focus to Iterum at the point of ORLYNVAH's launch.
• Tetraphase Biosciences: Tetraphase developed eravacycline (Xerava) for complicated intra-abdominal infections — a similarly differentiated, smaller-player anti-infective against MDR gram-negatives, now operating under Innoviva.
• Paratek Pharmaceuticals: Paratek developed and commercialized Nuzyra (omadacycline), a differentiated antibiotic for community-acquired bacterial pneumonia and acute skin infections, mirroring Iterum's small-cap anti-infective commercial model.
• Nabriva Therapeutics: Nabriva developed and commercialized lefamulin (Xenleta), a first-in-class pleuromutilin antibiotic for community-acquired bacterial pneumonia — a closely analogous small-cap anti-infective launch with similar commercial-execution challenges.

Broad incumbents

• GSK: GSK received FDA approval for gepotidacin (Blujepa) for uUTIs in 2025, directly competing with ORLYNVAH in the resistant-uUTI space while operating across a much broader infectious disease and vaccines portfolio.
• Shionogi: Shionogi developed Fetroja/cefiderocol for MDR gram-negative infections, the closest large-pharma analog to sulopenem's spectrum; comparable in mechanism intent (siderophore/β-lactam strategy vs. penem strategy) and resistant-pathogen positioning.
• Merck & Co. Merck markets Recarbrio and Zerbaxa for MDR gram-negative infections, providing a comparable large-cap commercial benchmark for what scaled uptake of a hospital/community β-lactam-based franchise looks like in the U.S.

Emerging players

• VenatoRx Pharmaceuticals: VenatoRx is developing cefepime-taniborbactam for MDR gram-negative infections (acquired by GARDP for global rights), directly comparable as a small-cap anti-infective R&D story targeting the same AMR unmet need.

Others

• Pfizer: Pfizer is the licensor of the sulopenem technology and a broader anti-infective incumbent (with established hospital antibiotics), making it the most operationally entangled peer via the deferred $20M milestone and ongoing royalty relationship.

Market position

Strengths3 records

Weaknesses4 records

Competitive moat3 records

Key risks6 records

Key highlights5 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Subsidiaries4 records

Funding overview

Funding rounds8 records

Investors12 records

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M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Iterum Therapeutics