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AltSonflex1-2-3
AltSonflex1-2-3 is a Sonic hedgehog pathway inhibitor Biologic drug developed by GlaxoSmithKline. It is currently in Phase 2 development for Metastatic basal cell carcinoma. Also known as: GSK's Shigella vaccine.
AltSonflex1-2-3 is a small molecule that modulates the sonic hedgehog signaling pathway.
AltSonflex1-2-3 is a small molecule that modulates the sonic hedgehog signaling pathway. Used for Metastatic basal cell carcinoma.
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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). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies. -
Big-pharma sponsor
+3.0pp
GlaxoSmithKline is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | AltSonflex1-2-3 |
|---|---|
| Also known as | GSK's Shigella vaccine |
| Sponsor | GlaxoSmithKline |
| Drug class | Sonic hedgehog pathway inhibitor |
| Target | Sonic hedgehog receptor |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
The exact mechanism of action of AltSonflex1-2-3 is not well understood, but it is believed to inhibit the activity of the sonic hedgehog pathway, which is involved in the development and progression of certain types of cancer.
Approved indications
- Metastatic basal cell carcinoma
Common side effects
- Fatigue
- Nausea
- Diarrhea
Key clinical trials
- A Study on the Immune Response and Safety of a Multicomponent Shigella Vaccine in Preventing Shigellosis in Infants (PHASE2)
- Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African Children (PHASE2)
- A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants (PHASE1)
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:
- AltSonflex1-2-3 CI brief — competitive landscape report
- AltSonflex1-2-3 updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about AltSonflex1-2-3
What is AltSonflex1-2-3?
How does AltSonflex1-2-3 work?
What is AltSonflex1-2-3 used for?
Who makes AltSonflex1-2-3?
Is AltSonflex1-2-3 also known as anything else?
What drug class is AltSonflex1-2-3 in?
What development phase is AltSonflex1-2-3 in?
What are the side effects of AltSonflex1-2-3?
What does AltSonflex1-2-3 target?
Related
- Drug class: All Sonic hedgehog pathway inhibitor drugs
- Target: All drugs targeting Sonic hedgehog receptor
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic basal cell carcinoma
- Also known as: GSK's Shigella vaccine
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing