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Sodium Stibogluconate (SSG)
Sodium Stibogluconate (SSG) is a Antiparasitic agent Small molecule drug developed by U.S. Army Medical Research and Development Command. It is currently in Phase 3 development for Visceral leishmaniasis, Cutaneous leishmaniasis, Mucocutaneous leishmaniasis. Also known as: Pentostam (GlaxoSmithKline).
Sodium stibogluconate is a pentavalent antimony compound that kills Leishmania parasites by generating reactive oxygen species and inhibiting their glycolytic enzymes.
Sodium Stibogluconate (SSG) is a small molecule used to treat various conditions, including Cutaneous Leishmaniasis, Primary Visceral Leishmaniasis, and Myelodysplastic Syndromes. It is also being studied in clinical trials for its potential use in treating Cancer.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Sodium Stibogluconate (SSG) |
|---|---|
| Also known as | Pentostam (GlaxoSmithKline) |
| Sponsor | U.S. Army Medical Research and Development Command |
| Drug class | Antiparasitic agent |
| Target | Leishmania glycolytic enzymes; reactive oxygen species generation |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
The drug is converted intracellularly to trivalent antimony, which disrupts the parasite's energy metabolism and generates oxidative stress leading to parasite death. It has been the first-line treatment for leishmaniasis for decades, though the exact molecular mechanism remains incompletely understood. The compound accumulates in infected macrophages where Leishmania resides.
Approved indications
- Visceral leishmaniasis
- Cutaneous leishmaniasis
- Mucocutaneous leishmaniasis
Common side effects
- Arthralgia and myalgia
- Pancreatitis
- Cardiotoxicity (QT prolongation)
- Elevated liver enzymes
- Renal impairment
- Injection site reactions
Key clinical trials
- Effects of Blood Flow Restriction and Small-Sided Games on Soccer Passing and Dribbling Stability Under Fatigue (NA)
- Study Comparing Several Drugs to Understand Which Work Against Cutaneous Leishmaniasis (CL) (PHASE3)
- LXE408 for Treatment of Visceral Leishmaniasis in Ethiopia, a Proof of Concept Study (PHASE2)
- Ciprofloxacin Intralesional Injection for the Treatment of Cutaneous Leishmaniasis Compared to Sodium Stibogluconate (PHASE2)
- A Study to Assess Immune Response Status in Patients Before and After Treatment for Visceral Leishmaniasis
- Documentation of Patient Outcomes for SSG/Allopurinol Combination Treatment in Ethiopia
- Miltefosine/Paromomycin Phase III Trial for Treatment of Primary Visceral Leishmaniasis (VL) Patients in Eastern Africa (PHASE3)
- Compassionate Use of Sodium Stibogluconate (Pentostam) for Cutaneous and Mucocutaneous New World Leishmaniasis
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Sodium Stibogluconate (SSG) CI brief — competitive landscape report
- Sodium Stibogluconate (SSG) updates RSS · CI watch RSS
- U.S. Army Medical Research and Development Command portfolio CI
Frequently asked questions about Sodium Stibogluconate (SSG)
What is Sodium Stibogluconate (SSG)?
How does Sodium Stibogluconate (SSG) work?
What is Sodium Stibogluconate (SSG) used for?
Who makes Sodium Stibogluconate (SSG)?
Is Sodium Stibogluconate (SSG) also known as anything else?
What drug class is Sodium Stibogluconate (SSG) in?
What development phase is Sodium Stibogluconate (SSG) in?
What are the side effects of Sodium Stibogluconate (SSG)?
What does Sodium Stibogluconate (SSG) target?
Related
- Drug class: All Antiparasitic agent drugs
- Target: All drugs targeting Leishmania glycolytic enzymes; reactive oxygen species generation
- Manufacturer: U.S. Army Medical Research and Development Command — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Visceral leishmaniasis
- Indication: Drugs for Cutaneous leishmaniasis
- Indication: Drugs for Mucocutaneous leishmaniasis
- Also known as: Pentostam (GlaxoSmithKline)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing