How to Access Phage Therapy in the United States: Clinical Trials, Expanded Access and Treatment Centers
Phage therapy is not an FDA-approved treatment in the United States as of October 2026. For a patient with a difficult bacterial infection, access generally follows one of two routes: enrollment in a clinical trial or FDA expanded access, commonly called compassionate use. The second route can allow an individual patient to receive an investigational bacteriophage when the infection is serious or immediately life-threatening, satisfactory alternatives are unavailable, the expected benefit justifies the risk and a suitable phage product can actually be obtained. The process is medical rather than consumer-facing: patients cannot simply order therapeutic phages or file an application themselves. A licensed physician must take responsibility for the treatment and regulatory process.
For most patients, the best first step is therefore not contacting dozens of phage laboratories independently but finding an infectious-disease physician willing to review the case. The physician will need a well-documented bacterial infection, recent cultures and susceptibility data, the treatment history, information on prior surgery or source-control attempts, and evidence explaining why conventional options are inadequate. A current bacterial isolate is particularly valuable because therapeutic phages are highly strain-specific. A laboratory must usually test the patient's bacterium against existing phage collections before anyone knows whether a usable treatment exists.
Clinical trials should normally be considered before compassionate use when an appropriate study is available. Trial participation gives access to a standardized investigational product under a predefined protocol, with manufacturing, dosing, monitoring and safety reporting already organized. Eligibility is usually narrow, however. A trial for chronic Achromobacter infection in adults with cystic fibrosis does not provide a route for a patient with an infected knee prosthesis, even if both patients are seeking phage therapy.
One of the most recent U.S. examples is AchromoPhage, a Phase 1 study that began in 2026 for adults with cystic fibrosis and chronic Achromobacter respiratory infection. The investigational product contains four lytic phages and is being evaluated by inhaled, intravenous and sequential inhaled-plus-intravenous administration. The study is recruiting through the University of Pittsburgh and UC San Diego and is expected to enroll only 12 participants, illustrating both the progress of U.S. clinical phage research and the narrow eligibility typical of early trials.
Another actively recruiting programme is ELIMINATE, the Locus Biosciences Phase 2 study of LBP-EC01 for acute uncomplicated urinary tract infection caused by drug-resistant Escherichia coli. LBP-EC01 is an engineered bacteriophage product, and the study had multiple recruiting sites across the United States in its September 2026 registry update. Unlike personalized compassionate-use treatment, participants receive a defined investigational product under the trial protocol.
A separate Phase 1b study led by Washington University School of Medicine is recruiting adults with spinal cord injury, neurogenic bladder and E. coli bacteriuria. It uses phages selected according to susceptibility testing and administered directly into the bladder. Sites include Washington University in St. Louis and the Michael E. DeBakey VA Medical Center in Houston. Another current programme, SNIPR001, uses genetically modified bacteriophages targeting fluoroquinolone-resistant E. coli in patients undergoing allogeneic hematopoietic stem-cell transplantation; individual participating sites may differ in recruitment status, making the live ClinicalTrials.gov record or site-specific trial page essential before arranging travel.
The U.S. commercial pipeline is also moving toward later-stage development. Armata Pharmaceuticals completed its randomized Phase 1b/2a diSArm study of intravenous AP-SA02 as an adjunct to antibiotics for complicated Staphylococcus aureus bacteremia and received FDA feedback supporting progression to Phase 3. In September 2026, Armata announced another $3.7 million in U.S. government support, bringing cumulative non-dilutive support under the programme to approximately $32.4 million. The company continued to describe Phase 3 initiation as planned for the second half of 2026, but patients should not assume a trial is recruiting until a current registry listing provides sites and enrollment contacts.
The status of older programmes is equally important because internet searches frequently return outdated phage trials. BiomX's inhaled BX004 programme for chronic Pseudomonas aeruginosa infection in cystic fibrosis has been discontinued, despite older hospital and trial pages remaining searchable. Adaptive Phage Therapeutics, once one of the best-known U.S. personalized-phage companies, was being wound down in 2026 after becoming part of BiomX. Patients should therefore verify every trial directly rather than relying on articles or search results several years old.
When no suitable trial exists, individual-patient expanded access becomes the principal U.S. pathway. The FDA updated its expanded-access guidance in April 2026. For a non-emergency individual case, the treating physician typically obtains agreement from the organization supplying the investigational phage, secures a Letter of Authorization when the supplier has an existing IND that can be referenced, submits FDA Form 3926, obtains Institutional Review Board approval and obtains informed consent. Treatment can begin once FDA authorizes it or after the applicable regulatory waiting period, provided the other requirements have been satisfied.
Emergency access is faster when the clinical situation cannot wait for the normal written process. A physician can contact the FDA by telephone or another rapid communication route and, if authorization is granted, treatment may begin immediately. The written Form FDA 3926 submission then follows within 15 business days. If there was insufficient time for prior IRB review, the emergency use must be reported to the IRB within five working days. Emergency expanded access should not be confused with the FDA's Emergency Use Authorization system used during declared public-health emergencies; these are different regulatory mechanisms.
FDA authorization is only one part of the process. A physician still needs an actual phage product suitable for human use. That requires finding one or more phages active against the patient's bacterial isolate, propagating them, performing genomic and biological characterization, purifying the preparation, documenting sterility and other quality parameters, and arranging shipment to the treating institution. This is why a technically eligible patient may still be unable to receive therapy: no active phage may be found, manufacturing capacity may be unavailable or the infection may progress faster than a personalized product can be prepared.
The Center for Innovative Phage Applications and Therapeutics, or IPATH, at UC San Diego remains one of the most established U.S. access points. IPATH prioritizes serious multidrug-resistant or device-associated infections, including life- or limb-threatening infections, complicated urinary tract infections, transplant-related cases and infections involving implanted hardware. Patients already treated within UC San Diego Health can be evaluated there, while outside patients generally remain under the care of their own physician. IPATH acts as a consultant, can help identify laboratories capable of testing and preparing phages and can guide the treating doctor through the FDA process. Its public guidance specifically asks outside patients to have their physician contact the centre rather than expecting IPATH to take over their medical care.
That distinction matters. A patient living in another state does not necessarily need to relocate to San Diego to receive phage therapy. If a suitable phage is found and the regulatory requirements are completed, the preparation may in some circumstances be shipped to the patient's treating hospital. UC San Diego estimates that identifying and preparing personalized phages can take several weeks, although emergency cases and existing products can differ substantially.
The Yale Center for Phage Biology & Therapy in New Haven operates an active compassionate-use programme alongside clinical research. Yale has treated patients with infections involving the lungs, implanted devices and other sites and maintains collections of therapeutic phages. Its public FAQ explicitly invites inquiries concerning multidrug-resistant infections and identifies Benjamin Chan as a contact for phage-therapy questions. Yale's model combines phage discovery, bacterial matching, translational research and clinical collaboration, making it one of the few U.S. academic programmes spanning the route from environmental phage isolation to bedside treatment.
The Pittsburgh Phage Program, or P3, at the University of Pittsburgh and UPMC provides another particularly clear access route. P3 performs phage discovery, manufacturing, compassionate use and clinical trials and works with pathogens including Pseudomonas aeruginosa, Enterococcus, Klebsiella pneumoniae, Achromobacter, Enterobacter and Stenotrophomonas. Physicians can contact P3 directly. UPMC patients can pursue evaluation through their treating team, while non-UPMC patients are asked to have their local physician contact the programme. Importantly, P3 states that outside patients cannot simply transfer their care to UPMC solely to obtain compassionate-use phages; instead, P3 can prepare phages that are administered under the supervision of the patient's local physician. The programme says personalized preparation may require several weeks to several months.
Pittsburgh has expanded considerably during 2026. NIAID established the first coordinated U.S. research network specifically designed to accelerate phage therapeutics against ESKAPE pathogens, and Pitt received one of the programme awards to establish the Pitt Center for Accelerating Phage Therapy. This does not create automatic patient access, but it strengthens the laboratory, pharmacological and manufacturing infrastructure behind future clinical programmes.
At Baylor College of Medicine in Houston, TAILOR — Tailored Antibacterials and Innovative Laboratories for phage Research — has developed personalized phages and has experience supporting compassionate-use treatment. Baylor describes TAILOR as a nonprofit initiative offering at-cost services and an integrated bench-to-bedside development pipeline. However, TAILOR should not be interpreted as a conventional clinic where a patient can book phage treatment directly. The practical route remains collaboration between clinicians, the laboratory and appropriate regulatory authorities.
Baylor's phage programme also illustrates the distinction between an academic centre and a private biotechnology company. PHIOGEN, founded in 2023 to commercialize technology originating from TAILOR, is developing population-level phage therapeutics, including PHI-UI-01 for recurrent urinary tract infection. As of October 2026, PHIOGEN describes itself as preclinical. Its collaboration with Baylor and LillixBio announced on October 8 is investigating immune responses generated after phage-mediated bacterial lysis, but PHIOGEN is not currently a walk-in treatment clinic for patients seeking compassionate phage therapy.
The Mayo Clinic Phage Therapy Program in Rochester, Minnesota, has treated patients and maintains a dedicated phage registry and biobank led by Gina Suh. Its NCT05314426 observational programme follows people who have received or are scheduled to receive phage therapy and collects clinical and biological samples. The important practical limitation is that this biobank is enrollment-by-invitation and should not be mistaken for an open national application portal for phage treatment. Patients interested in Mayo should pursue evaluation through Mayo's clinical system and confirm current capacity directly rather than assuming that participation in the biobank provides access to therapy.
The Center for Phage Technology at Texas A&M University is also frequently included in lists of major American phage centres and has a long history of phage discovery, genomics and collaboration, including contributions to early U.S. emergency treatments. It is primarily a research centre, however, rather than a general clinical treatment service. For patients, that difference is crucial: an institution possessing phage expertise or a phage library is not necessarily authorized or equipped to become the treating medical centre.
Private companies play a different role again. Armata Pharmaceuticals develops standardized clinical products such as AP-SA02 and AP-PA02 and operates its own phage manufacturing capabilities. Locus Biosciences develops engineered phages, including LBP-EC01, through formal clinical trials. Intralytix maintains therapeutic research programmes and phage manufacturing expertise, including EcoActive targeting adherent-invasive E. coli in Crohn's disease. These companies usually provide access through sponsored trials, collaborations or formal expanded-access arrangements rather than selling individualized treatment directly to patients.
This distinction between academic centres and private developers is one of the easiest parts of U.S. access to misunderstand. Academic programmes such as IPATH, Yale or P3 may help physicians evaluate individual difficult cases and search multiple phage sources. Pharmaceutical companies are generally trying to develop reproducible products for regulatory approval in defined patient populations. A patient with an unusual resistant infection may therefore be more relevant to a personalized academic programme, while someone meeting the eligibility criteria for a standardized investigational product may be better served through a company-sponsored clinical trial.
Patients should also be cautious about any U.S. organization advertising phage therapy as an ordinary commercial medical service. Because no therapeutic bacteriophage product is currently FDA-approved for routine treatment of bacterial infections, human administration outside a legitimate clinical trial generally requires an appropriate investigational regulatory pathway. A clinic should be able to explain who the treating physician is, which IND or protocol authorizes the product, who manufactured the phage, what quality testing was performed and what IRB oversight applies.
The bacterial isolate is often the practical starting point for personalized access. A patient should ask the treating infectious-disease specialist whether a recent isolate is available and whether the microbiology laboratory can preserve it for shipment. Medical records should ideally document the organism, antibiotic susceptibility profile, dates and results of cultures, previous antimicrobial regimens, surgical procedures, allergies, relevant imaging and why standard treatment has failed or is unsuitable. Sending an incomplete case to a phage centre can delay assessment considerably.
Not every difficult infection is a good candidate. UC San Diego specifically warns that situations involving several different bacteria over time can be difficult because it may be unclear which organism is driving the disease and finding separate phages for multiple potential pathogens can be impractical. Likewise, an organism being antibiotic-resistant does not automatically make it phage-susceptible.
Costs are another practical consideration. Expanded access does not mean that every element of treatment is free. Some academic programmes provide phages without a commercial drug charge, while laboratories may charge at-cost fees for searching, purification, testing or preparation. Hospital pharmacy work, shipping, bacterial cultures, phage-specific laboratory tests, infusion or inhalation procedures, inpatient care and follow-up may create additional costs. Insurance may cover ordinary medical care while not covering experimental-product preparation, so patients should obtain written estimates from both the phage provider and treating hospital before assuming a particular financial arrangement.
For a U.S. patient seeking phage therapy in 2026, the most efficient pathway is therefore relatively clear. Start with a physician experienced in complex infection, determine whether a currently recruiting clinical trial matches the disease, preserve a recent bacterial isolate, and use an established phage programme when individualized treatment is necessary. The physician — not the patient alone — then works with the phage supplier, FDA and IRB to determine whether expanded access can proceed.
The landscape is changing quickly. AchromoPhage entered human testing in 2026, Locus continues recruiting its large UTI study, personalized urinary phage trials are underway, and Armata is preparing what could become the first Phase 3 programme for a systemic bacteriophage product in the United States. At the same time, older programmes such as BX004 and Adaptive Phage Therapeutics demonstrate why patients should always verify current status before contacting a centre or arranging travel.
For a continuously updated directory of hospitals, research programmes and phage-treatment resources, readers can also consult Phage Healthcare. The directory should be used as a starting point rather than a guarantee of treatment: eligibility ultimately depends on the infection, bacterial isolate, available phages, physician involvement, manufacturing capacity and the applicable FDA pathway.
Sources :
U.S. Food and Drug Administration — Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers, revised April 2026. The guidance defines the current criteria and pathways for individual-patient, intermediate-size and treatment expanded access. U.S. Food and Drug Administration
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/expanded-access-investigational-drugs-treatment-use-questions-and-answers
U.S. Food and Drug Administration — How to Submit an Expanded Access Request. Includes the current process for Form FDA 3926, Letters of Authorization, IRB review, informed consent and emergency access. U.S. Food and Drug Administration
https://www.fda.gov/news-events/expanded-access/expanded-access-how-submit-request-forms
U.S. Food and Drug Administration — How Physicians Request Single-Patient Expanded Access. FDA states that more than 99% of single-patient expanded-access requests are allowed to proceed. U.S. Food and Drug Administration
https://www.fda.gov/drugs/investigational-new-drug-application-ind/physicians-how-request-single-patient-expanded-access-compassionate-use
UC San Diego — IPATH Phage Therapy FAQ. Provides current eligibility priorities, physician-referral process, expanded-access guidance, phage-search timelines and financial considerations. idgph.ucsd.edu
https://idgph.ucsd.edu/research/center-innovative-phage-applications-and-therapeutics/clinical-trial/faq-phage-therapy.html
Yale University — Center for Phage Biology & Therapy. Yale confirms an active compassionate-use programme and ongoing clinical deployment of therapeutic phages. Center for Phage Biology & Therapy
https://phage.yale.edu/
University of Pittsburgh / UPMC — Pittsburgh Phage Program. Details P3's expanded-access process, physician contacts, outside-patient policy, production timelines and cost model. Médecine Pitt
https://dom.pitt.edu/id/research/phage/
Baylor College of Medicine — TAILOR. Describes Baylor's nonprofit personalized-phage programme and its at-cost laboratory model. Baylor College of Medicine
https://www.bcm.edu/research/research-centers/tailor
Mayo Clinic — Mayo Clinic Phage Program Biobank, NCT05314426. The programme follows people receiving phage therapy but is currently listed as enrollment by invitation. Mayo Clinic
https://www.mayo.edu/research/clinical-trials/cls-20531162
University of Pittsburgh / NIAID — NIH Funds First Coordinated U.S. Research Network for Phage Therapeutics, May 2026. NIAID funded three Centers for Accelerating Phage Therapy to Combat ESKAPE Pathogens. Médecine Pitt
https://dom.pitt.edu/nih-funds-first-coordinated-u-s-research-network-for-phage-therapeutics/
Clinical trial NCT07275905 — AchromoPhage, Phase 1 study in adults with cystic fibrosis and chronic Achromobacter infection. Recruiting in 2026. Essais Cliniques
https://clinicaltrials.gov/study/NCT07275905
Clinical trial NCT05488340 — ELIMINATE, Locus Biosciences Phase 2 study of LBP-EC01 for drug-resistant E. coli urinary tract infection. Registry information remained recruiting in September–October 2026. deltatrials
https://clinicaltrials.gov/study/NCT05488340
Clinical trial NCT06559618 — Bacteriophage Therapy in Spinal Cord Injury Patients With Bacteriuria. Recruiting Phase 1b study at Washington University and the Michael E. DeBakey VA Medical Center. Eichor
https://clinicaltrials.gov/study/NCT06559618
MD Anderson Cancer Center — SNIPR001 clinical study, genetically modified bacteriophages targeting fluoroquinolone-resistant E. coli before allogeneic transplantation. UT MD Anderson
https://clinicaltrials.gov/study/NCT06938867
Armata Pharmaceuticals — AP-SA02 Phase 3 development. In September 2026 Armata received an additional $3.7 million in non-dilutive funding, bringing cumulative support under the U.S. government award to approximately $32.4 million; Phase 3 initiation remained planned for the second half of 2026. SEC
https://www.armatapharma.com/pipeline/ap-sa02/
Cystic Fibrosis Foundation — BX004-A status. The BiomX inhaled Pseudomonas phage programme is listed as discontinued. CFF
https://apps.cff.org/Trials/Pipeline/details/10190/BX004-A
BiomX / SEC — Adaptive Phage Therapeutics status. BiomX reported in 2026 that APT was being wound down and preparing for Chapter 7 proceedings, an important caution when consulting older personalized-phage resources. SEC
Intralytix — Clinical phage programmes and compassionate-use activities. Intralytix, Inc.
https://www.intralytix.com/
PHIOGEN / Baylor College of Medicine — Current preclinical development emerging from Baylor's TAILOR technology. Phiogen
https://www.phiogenpharma.com/
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