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Drugs in development · updated 5 November 2026

Congenital syphilis: drugs in development

Rare diseasePrevalence 1-9 / 100 000 according to Orphanet · ORPHA:499009

What it is

A rare teratologic disease caused by vertical transmission of the spirochete Treponema pallidum from an infected mother to the fetus, characterized by early congenital syphilis during the first two years of life (maculopapular rash progressing to desquamation, hepatosplenomegaly, osteochondritis, snuffles, and iritis), followed by late congenital syphilis with the classic Hutchinson's triad of Hutchinson's teeth, interstitial keratitis, and eighth nerve deafness. Additional signs may include saddle nose, saber shins, seizures, and mental retardation. Congenital syphilis can also result in stillbirth, neonatal death, and nonimmune hydrops.

Source: Orphanet, “Congenital syphilis” (ORPHA:499009), www.orpha.net · licence CC BY 4.0 · Orphadata data of 23 June 2026.

As of 5 November 2026 there are 2 active clinical trials (recruiting or ongoing, phases I–III) on 3 drugs for congenital syphilis. 0 are experimental, that is not yet approved in the United States.

2Active trials
0Experimental drugs
0Experimental, in phase III

Summary updated every week · data as of 5 November 2026. In Phuturdex you get the full detail of every drug and an email when an alert is published on the ones you follow.

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Approved drugs in new trials

Approved by the US FDA for at least one indication, not necessarily this disease, and now in active trials on it.

DrugMost advanced phaseActive trialsReference trial
AmoxicillinAmoxycillin, Moxatag®II1NCT06921213
Benzathine penicillinII1NCT07189208
LinezolidLinezolid In Sodium Chloride 0.9% In Plastic Container®, Zyvox®II1NCT06921213

Sorted by most advanced phase and number of active trials.

All 3 drugs, with the details

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Broader categories

Source: Phuturdex analysis of ClinicalTrials.gov data (U.S. National Library of Medicine), updated 5 November 2026. Active trials = recruiting or ongoing, phases I–III, with at least one identified drug; phase and sites refer to the trials on this disease. Disease name: Wikidata; NLM MeSH term: D013590 “Syphilis, Congenital”. Prevalence: Orphanet.

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