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Condition (MeSH)

Lyme Disease

ClinicalTrials.gov lists 114 trials for Lyme Disease or a narrower condition beneath it. National Institute of Allergy and Infectious Diseases (NIAID) has the most among industry and government lead sponsors, with 12.

MeSH D008193 Infections C01 Listed by Orphanet as a rare disease
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Phase 1 Phase 1 5 Phase 1/2 Phase 1/2 7 Phase 2 Phase 2 8 Phase 2/3 Phase 2/3 1 Phase 3 Phase 3 12 Phase 4 Phase 4 5 Not applicable Not applicable 31 Observational Observational 44 Phase 1 Phase 1 5 Phase 1/2 Phase 1/2 7 Phase 2 Phase 2 8 Phase 2/3 Phase 2/3 1 Phase 3 Phase 3 12 Phase 4 Phase 4 5 Not applicable Not applicable 31 Observational Observational 44

Trials per phase (log scale)

1 more section with rows

93 of the 114 trials are tagged with Lyme Disease itself; the rest are tagged with a narrower condition beneath it.

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The PDF carries up to 50 rows of each section, where the page shows the first few, with the sources listed. Enter a work email and confirm it from the message we send, and the report follows by email.

When did Lyme Disease trials start? (27)

Shown in this order: most recent first, 1990 onwards. 2026 is partial: trials registered with a 2026 start date so far, not a full year. 1 trial is registered to start in 2027 or later, and not listed here.

Trials over time, by phase

  • Phase 1
  • Phase 1/2
  • Phase 2
  • Phase 2/3
  • Phase 3
  • Phase 4
  • Not applicable
  • Observational
  • Other (Unknown)

Top of scale: 12

1996: 1 trials (Observational 1) 1997: 1 trials (Phase 3 1) 1999: 1 trials (Phase 2 1) 2002: 1 trials (Observational 1) 2004: 2 trials (Not applicable 1, Phase 3 1) 2005: 1 trials (Observational 1) 2006: 3 trials (Observational 2, Not applicable 1) 2007: 1 trials (Observational 1) 2008: 3 trials (Observational 2, Phase 3 1) 2009: 3 trials (Not applicable 3) 2010: 5 trials (Observational 1, Not applicable 1, Phase 4 1, Phase 1/2 1, Phase 1 1) 2011: 2 trials (Observational 1, Phase 4 1) 2012: 1 trials (Phase 4 1) 2013: 3 trials (Not applicable 3) 2014: 1 trials (Observational 1) 2015: 4 trials (Observational 1, Not applicable 2, Phase 3 1) 2016: 2 trials (Not applicable 2) 2017: 5 trials (Observational 2, Not applicable 2, Phase 1 1) 2018: 6 trials (Observational 3, Not applicable 2, Phase 2 1) 2019: 12 trials (Observational 4, Not applicable 3, Phase 3 1, Phase 2/3 1, Phase 2 1, Phase 1/2 2) 2020: 5 trials (Observational 4, Not applicable 1) 2021: 9 trials (Observational 4, Not applicable 3, Phase 2 1, Phase 1 1) 2022: 7 trials (Other 1, Phase 3 2, Phase 2 2, Phase 1/2 1, Phase 1 1) 2023: 9 trials (Observational 6, Not applicable 2, Phase 1/2 1) 2024: 7 trials (Observational 4, Not applicable 2, Phase 1/2 1) 2025: 8 trials (Observational 2, Not applicable 3, Phase 4 1, Phase 3 1, Phase 1 1)

Trials registered with a start date in each year, 1990 onward, stacked by phase (complete years only; the current partial year is in the table's notes). The table below lists the same counts, most recent years first.

Trials started per year
Year Trials started
2026 (partial year) 7
2025 8
2024 7
2023 9
2022 7
2021 9
2020 5
2019 12
2018 6
2017 5

Showing 10 of 27 earlier years.

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Forecast of the full-year count, planned starts included, not rows of this table: about 8 trials starting in 2026 and about 8 in 2027, the average of the 24 months through September, counted as registered and carried forward. The rows of this table count trials registered so far with a start date in the year, planned starts included; the forecast looks ahead to the count for the whole year, so it is not the same measure. In backtests on conditions of this size, forecasts made part-way through the year were typically off by about 28 percent and ran about 20 percent low against the count later registered; forecasts made before the year began were off by about 39 percent and ran about 37 percent low against the count later registered. These figures rest on a few years of history (target years from 2018 to 2025, varying by figure), place each condition as it is mapped today rather than as it was then, and score against a count for the newest year that was still being revised. Only condition series were scored.

Prediction, not a registry value: median of 29 months from start to primary completion across 12 trials still running at the 2026-10-09 snapshot; registered median of 23 months across 52 trials with a primary completion typed Actual. Source: ClinicalTrials.gov / AACT (CTTI), public domain.

What phase are Lyme Disease trials in? (9)

Shown in this order: phase order.

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Trials by phase
Phase Trials
Phase 1 5
Phase 1/2 7
Phase 2 8
Phase 2/3 1
Phase 3 12
Phase 4 5
Not applicable 31
Observational 44
Unknown 1

How many Lyme Disease trials are recruiting? (9)

Shown in this order: the order a trial moves through, from not yet recruiting to unknown.

Trials by recruitment status
Status Trials
Not yet recruiting 7
Recruiting 21
Enrolling by invitation 1
Active, not recruiting 4
Completed 48

Showing 5 of 9 statuses.

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Status as registered on ClinicalTrials.gov. Each trial is counted once.

Which lead sponsors run the most Lyme Disease trials? (4)

Shown in this order: most trials first. Lead sponsors the registry classes as industry, NIH, US federal, other government or network. A hospital or university the registry files as government can appear here. Sponsors it classes as academic or other are shown on the full page, because that class cannot separate an institution from a named investigator.

Lead sponsors
Sponsor Trials
National Institute of Allergy and Infectious Diseases (NIAID) 12
Pfizer 8
ModernaTX, Inc. 2
National Institute of Neurological Disorders and Stroke (NINDS) 2

Interventions as named in the registry (15)

Shown in this order: most trials first.

Interventions as named in the registry
Drug Trials
Doxycline 13
Ceftriaxone 4g/ 24h 10
VLA15 7
Controls without a history of lyme disease. 2
mRNA-1982 2

Showing 5 of 15 interventions.

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These are the names sponsors entered on ClinicalTrials.gov that we have not matched to a single molecule. Some are drugs under a brand or code name; others are procedures, doses or arm labels.

Which serious adverse events do Lyme Disease trials report? (10)

Shown in this order: most subjects affected first. Subjects affected summed across trials, a cross-trial signal, not a rate.

Serious adverse events in this condition's trials
Adverse event Subjects affected Trials
Gastrointestinal symptoms, Photosensitivity 56 1
Appendicitis 12 4
Suicidal ideation 12 2
Type 1 diabetes mellitus 10 2
Depression 6 1

Showing 5 of 10 adverse events.

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Which publications cover Lyme Disease? (70)

Shown in this order: major-topic papers first, then newest, then most linked to trials.

Publications
Publication Journal Year Major topic
Borrelia burgdorferi infections in children and adolescents in Switzerland - a seroprevalence study 2023/2024 (BOBUINCA). Infection 2025 Yes
Detection of Borrelia burgdorferi sensu lato by proteomics: a complementary diagnosis tool on erythema migrans biopsies. Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases 2025 Yes
Immunogenicity and safety of different immunisation schedules of the VLA15 Lyme borreliosis vaccine candidate in adults, adolescents, and children: a randomised, observer-blind, placebo-controlled, phase 2 trial. The Lancet. Infectious diseases 2025 Yes
Optimisation of dose level and vaccination schedule for the VLA15 Lyme borreliosis vaccine candidate among healthy adults: two randomised, observer-blind, placebo-controlled, multicentre, phase 2 studies. The Lancet. Infectious diseases 2024 Yes
Identification of reactive <i>Borrelia burgdorferi</i> peptides associated with Lyme disease. mBio 2024 Yes

Showing 5 of 70 publications.

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Prevalence (21)

Shown in this order: jurisdiction, then disease name. Orphanet observation for the mapped ORPHA concept; the mapping relation column says whether that concept is exactly this condition or broader or narrower.

Prevalence
Orphanet disease Type Class Geography Jurisdiction Mapping relation
Lyme disease Annual incidence >1 / 1000 United States US Exact
Lyme disease Annual incidence >1 / 1000 United States US Unspecified
Lyme disease Annual incidence >1 / 1000 United States US Exact
Lyme disease Annual incidence >1 / 1000 Europe Not stated Unspecified
Lyme disease Annual incidence 1-5 / 10 000 France Not stated Unspecified

Showing 5 of 21 prevalence observations.

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Rare-disease identity (2)

Shown in this order: exact, broader, narrower, other.

Rare-disease identity
Orphanet disease ORPHA code Relation Source
Lyme disease 91546 Exact Orphadata Science knowledge files, Product 1
Lyme disease 91546 Exact Orphanet Rare Disease Ontology (ORDO)

Sub-conditions in MeSH (3)

MeSH descendants one level down with at least one trial, most trials first.

Not on this page

Not measured: delivery record.

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