Last reviewed · How we verify
Vaccae
Vaccae is a Small molecule drug developed by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.. It is currently in Phase 3 development. Also known as: Mycobacterium vaccae for Injection.
Mycobacterium Vaccae, also known as Vaccae, is an injection used in clinical trials to study its safety, efficacy, and immunogenicity in treating Latent Tuberculosis Infection, Tuberculosis, and HIV Infections. It has been tested in a Phase IV clinical trial, NCT05680415, conducted by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
-
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 | Vaccae |
|---|---|
| Also known as | Mycobacterium vaccae for Injection |
| Sponsor | Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Clinical Trial of Mica (PHASE4)
- TB Immunotherapy Trial With Heat-killed M. Vaccae (PHASE3)
- Phase III Clinical Study of Efficacy and Safety of Vaccae™ to Prevent Tuberculosis (PHASE3)
- Investigational Vaccine for the Prevention of Disseminated Tuberculosis in HIV Infected People (PHASE2, PHASE3)
- Tuberculosis (TB) Immunotherapy Phase 2 Study (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:
- Vaccae CI brief — competitive landscape report
- Vaccae updates RSS · CI watch RSS
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. portfolio CI
Frequently asked questions about Vaccae
What is Vaccae?
Who makes Vaccae?
Is Vaccae also known as anything else?
What development phase is Vaccae in?
Related
- Manufacturer: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Mycobacterium vaccae for Injection
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing