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Pentostam
Pentostam is a Small molecule drug developed by Sheba Medical Center. It is currently in Phase 2 development for Leishmaniasis. Also known as: Pentavalent antimonials.
Pentostam, also known as sodium stibogluconate, is a medication used to treat leishmaniasis, including cutaneous, visceral, and mucosal types. It is administered by injection.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Pentostam |
|---|---|
| Also known as | Pentavalent antimonials |
| Sponsor | Sheba Medical Center |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
- Leishmaniasis
Common side effects
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:
- Pentostam CI brief — competitive landscape report
- Pentostam updates RSS · CI watch RSS
- Sheba Medical Center portfolio CI
Frequently asked questions about Pentostam
What is Pentostam?
What is Pentostam used for?
Who makes Pentostam?
Is Pentostam also known as anything else?
What development phase is Pentostam in?
Related
- Manufacturer: Sheba Medical Center — full pipeline
- Therapeutic area: All drugs in Other
- Indication: Drugs for Leishmaniasis
- Also known as: Pentavalent antimonials
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing