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Biomarker and diagnostic research for necrotizing soft tissue infection has been reported in the published literature.
No approved treatments are currently available for necrotizing soft tissue infection. An additional 1 compound holds orphan drug designation.
While no drugs are FDA-approved specifically for necrotizing soft tissue infection, some of the following designated compounds may be used off-label in clinical practice. Treatment decisions should be made in consultation with a specialist familiar with this condition.
The following drugs have received orphan drug designation from the FDA for necrotizing soft tissue infection. Orphan designation reflects regulatory interest and does not indicate approval for treatment.
Brand Name | Generic Name | Sponsor |
|---|
6 clinical trials registered, 3 recruiting. Interventions under study include other interventions, medical devices, and drug therapy. Pipeline includes 1 PHASE4, 2 NA. Research is sponsored by a mix of industry and academic institutions.
NCT ID | Title | Phase | Sponsor | Status |
|---|---|---|---|---|
[NCT07107555](https://clinicaltrials.gov/study/NCT07107555) |
Data assembled from 5 of 12 sources · Last updated Sep 18, 2026, 1:44 PM UTC
European rare disease database
Genetic and Rare Diseases Info Center
Designated
Exclusivity End |
|---|
Designation Status |
|---|
reltecimod | reltecimod | Atox Bio, Inc. | 2011 | — | Designated |
6 trials found
Necrotizing Soft Tissue Infections
— |
European Society for Trauma and Emergency Surgery |
UNKNOWN |
[NCT06857708](https://clinicaltrials.gov/study/NCT06857708) | The Management of Necrotizing Soft Tissue Infection Wounds With Cytal® Wound Matrix and MicroMatrix® | NA | Benjamin T. Miller | RECRUITING |
[NCT05243966](https://clinicaltrials.gov/study/NCT05243966) | Myriad™ Augmented Soft Tissue Reconstruction Registry | — | Aroa Biosurgery Limited | RECRUITING |
[NCT03482245](https://clinicaltrials.gov/study/NCT03482245) | The Role of Circadian Clock Proteins in Innate and Adaptive Immunity | NA | Washington University School of Medicine | RECRUITING |
[NCT07489274](https://clinicaltrials.gov/study/NCT07489274) | Adjunctive Hyperbaric Oxygen Treatment for Patients With Necrotizing Soft-Tissue Infection (HOT-NSTI Trial). | PHASE4 | Ole Hyldegaard | UNKNOWN |
179 publications have been identified in PubMed for necrotizing soft tissue infection. Research spans Case Report / Case Series (58%), Review / Meta-Analysis (15%), and Epidemiology / Natural History (12%).
Research Type | Count | % of Total |
|---|---|---|
Patient case studies | 104 | 58% |
Research summaries | 27 | 15% |
Disease patterns and progression | 21 | 12% |
Testing and diagnosis research | 10 | 6% |
Clinical study results | 10 | 6% |
Laboratory research | 5 | 3% |
Other research | 2 | 1% |
Hemapanpairoa J (2026). [PMID: 42213704](https://pubmed.ncbi.nlm.nih.gov/42213704/). *PLoS Negl Trop Dis*. [Epidemiology / Natural History]
Hayasaka M (2026). [PMID: 41485839](https://pubmed.ncbi.nlm.nih.gov/41485839/). *American journal of obstetrics and gynecology*. [Review / Meta-Analysis]
Yamazaki K (2026). [PMID: 41543271](https://pubmed.ncbi.nlm.nih.gov/41543271/). *mSystems*. [Basic Science / Preclinical]
Wang X (2026). [PMID: 41859062](https://pubmed.ncbi.nlm.nih.gov/41859062/). *Infection and drug resistance*. [Case Report / Case Series]
Alammar A (2026). [PMID: 41720016](https://pubmed.ncbi.nlm.nih.gov/41720016/). *Burns : journal of the International Society for Burn Injuries*. [Review / Meta-Analysis]
Soltau SR (2026). [PMID: 41045841](https://pubmed.ncbi.nlm.nih.gov/41045841/). *Diagnostic microbiology and infectious disease*. [Case Report / Case Series]
Rivet C (2026). [PMID: 41635014](https://pubmed.ncbi.nlm.nih.gov/41635014/). *Surgical infections*. [Case Report / Case Series]
Tinggaard M (2026). [PMID: 41545920](https://pubmed.ncbi.nlm.nih.gov/41545920/). *BMC infectious diseases*. [Other]
Nasu T (2026). [PMID: 41669577](https://pubmed.ncbi.nlm.nih.gov/41669577/). *Cureus*. [Case Report / Case Series]
Tai S (2026). [PMID: 41640918](https://pubmed.ncbi.nlm.nih.gov/41640918/). *Cureus*. [Case Report / Case Series]
AI-curated news mentioning necrotizing soft tissue infection
Updated Jul 14, 2026
A case report details a necrotizing soft tissue infection caused by Haemophilus influenzae type b in a vaccinated 16-month-old Inuit boy. This highlights potential gaps in vaccine efficacy and the need for further research on Hib infections in vaccinated populations.
A multicentre retrospective cohort study identifies key factors associated with in-hospital mortality in necrotising soft tissue infections. This research provides insights that could inform clinical practices and improve patient outcomes.