Last reviewed · How we verify
Monosialoganglioside
Monosialoganglioside is a Small molecule drug developed by Qilu Pharmaceutical Co., Ltd.. It is currently in Phase 3 development. Also known as: GM1, Monosialotetrahexosylganglioside Sodium Injection.
Monosialoganglioside is being studied as a potential treatment for various conditions, including neurotoxicity, acute ischemic stroke, early breast cancer, non-small cell lung cancer, and stroke. It is being investigated in clinical trials as a possible intervention to prevent or treat these conditions, with some trials comparing its effects to a placebo.
-
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).
| 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 | Monosialoganglioside |
|---|---|
| Also known as | GM1, Monosialotetrahexosylganglioside Sodium Injection |
| Sponsor | Qilu Pharmaceutical Co., Ltd. |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Monosialoganglioside in Acute Ischemic Stroke: a Randomized, Blinded and Multicenter Confirmatory Study (PHASE3)
- GM1 in the Treatment of Neurotoxicity Induced by Albumin-bound Paclitaxel (PHASE2)
- An Exploratory Study of Ganglioside GM1 in Acute Ischemic Stroke (PHASE4)
- Monosialoganglioside Ganglioside in Cerebral Radiation Necrosis (PHASE2)
- Monosialoganglioside(GM1) Preventing Neurotoxicity Induced by Cisplatin Contained Chemotherapy in NSCLC Patients (PHASE3)
- Monosialoganglioside Preventing Neurotoxicity Induced by Albumin-bound Paclitaxel Chemotherapy in Lung Cancer Patients (PHASE2)
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:
- Monosialoganglioside CI brief — competitive landscape report
- Monosialoganglioside updates RSS · CI watch RSS
- Qilu Pharmaceutical Co., Ltd. portfolio CI
Frequently asked questions about Monosialoganglioside
What is Monosialoganglioside?
Who makes Monosialoganglioside?
Is Monosialoganglioside also known as anything else?
What development phase is Monosialoganglioside in?
Related
- Manufacturer: Qilu Pharmaceutical Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: GM1, Monosialotetrahexosylganglioside Sodium Injection
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing