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Aluminum Adjuvant
Aluminum Adjuvant is a Biologic drug developed by Xiamen University. It is currently in Phase 3 development.
Aluminum hydroxide is a small molecule used as an antacid, and it has been studied in various clinical trials for conditions such as COVID-19, Shigellosis, and vaccine-preventable diseases. These trials have investigated its safety and immunogenicity in healthy individuals and those with certain diseases, including HIV/AIDS and COVID-19.
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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).
| 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 | Aluminum Adjuvant |
|---|---|
| Sponsor | Xiamen University |
| Modality | Biologic |
| Phase | Phase 3 |
Approved indications
Common side effects
- Injection site pain
- Fatigue
- Injection site erythema
- Injection site swelling
- Myalgia
- Headache
- Irritability
- Somnolence
- Decreased appetite
- Pyrexia
- Injection site induration
- Arthralgia
Key clinical trials
- A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes (PHASE1)
- A Safety and Immunogenicity Study of CHIKV VLP Vaccine in Children. (PHASE3)
- An Efficacy, Safety, and Immunogenicity Study of CHIKV VLP Vaccine for the Prevention of Chikungunya Disease in Adolescents and Adults (PHASE3)
- Evaluating the Safety and Immunogenicity of Stabilized CH505 TF chTrimer in Healthy, HIV-uninfected Adult Participants. (PHASE1)
- Evaluating Safety and Immune Response of Janssen, Moderna, Pfizer/BNT, and Novavax COVID-19 Vaccines for Same and Mixed Boosters in Adolescents and Adults Aged 12-64 With and Without HIV in Kenya, DRC, and Rwanda (PHASE2)
- Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy (PHASE1)
- A Study on the Safety and Immune Response of AS37 Together With Hepatitis B Antigen in Adults Aged 18-45 Years (PHASE1)
- Opportunistic Pneumococcal Immunisation Trial in MALnutrition (PHASE4)
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:
- Aluminum Adjuvant CI brief — competitive landscape report
- Aluminum Adjuvant updates RSS · CI watch RSS
- Xiamen University portfolio CI
Frequently asked questions about Aluminum Adjuvant
What is Aluminum Adjuvant?
Who makes Aluminum Adjuvant?
What development phase is Aluminum Adjuvant in?
What are the side effects of Aluminum Adjuvant?
Related
- Manufacturer: Xiamen University — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing