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GLA-SE adjuvant
GLA-SE adjuvant is a Biologic drug developed by National Institute of Allergy and Infectious Diseases (NIAID). It is currently in Phase 1 development. Also known as: glucopyranosyl lipid adjuvant-stable emulsion.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | GLA-SE adjuvant |
|---|---|
| Also known as | glucopyranosyl lipid adjuvant-stable emulsion |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
- Any Event in SOC
- Haemoglobin decreased
- Diarrhoea
- Upper respiratory tract infection
- Neutrophil count decreased
- Rash
- Underweight
- Gastroenteritis
- Cough
- Nasal congestion
- Vomiting
- Lower respiratory tract infection
Key clinical trials
- Evaluating the Safety and Immunogenicity of EnvSeq-1 and CH505 M5 gp120 Envs Adjuvanted With GLA-SE in Healthy, HIV-Uninfected Adults (PHASE1)
- Efficacy of Na-GST-1/Alhydrogel Hookworm Vaccine Assessed by Controlled Challenge Infection (PHASE2)
- A Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Sm-p80 + GLA-SE (SchistoShield®) Candidate Vaccine in Healthy Adults in Burkina Faso and Madagascar (PHASE1)
- Evaluating Safety and Immune Response to the HIV-1 CH505 Transmitted/Founder gp120 Adjuvanted With GLA-SE in Healthy, HIV-exposed Uninfected Infants (PHASE1)
- Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of HIV-1 Chimp Adenovirus Vaccines Expressing Clade C gp140 & CH505TF gp120 Protein Boost in HIV-uninfected Adult. (PHASE1)
- ID93/GLA-SE Vaccination + BCG Challenge (NA)
- Combination of MK3475 and Metronomic Cyclophosphamide in Patients With Advanced Sarcomas : Multicentre Phase II Trial (PHASE2)
- Safety and Immunogenicity of Recombinant Pichia Pastoris AMA1-DiCo Candidate Malaria Vaccine With GLA-SE and Alhydrogel ® as Adjuvant in Healthy Malaria Non-Exposed European and Malaria Exposed African Adults (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:
- GLA-SE adjuvant CI brief — competitive landscape report
- GLA-SE adjuvant updates RSS · CI watch RSS
- National Institute of Allergy and Infectious Diseases (NIAID) portfolio CI
Frequently asked questions about GLA-SE adjuvant
What is GLA-SE adjuvant?
Who makes GLA-SE adjuvant?
Is GLA-SE adjuvant also known as anything else?
What development phase is GLA-SE adjuvant in?
What are the side effects of GLA-SE adjuvant?
Related
- Manufacturer: National Institute of Allergy and Infectious Diseases (NIAID) — full pipeline
- Also known as: glucopyranosyl lipid adjuvant-stable emulsion
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing