Last reviewed · How we verify
LingZhi capsule
LingZhi capsule is a Herbal immunomodulator Small molecule drug developed by The University of Hong Kong. It is currently in Phase 3 development for Cancer supportive care and immunomodulation (Phase 3 indication under investigation). Also known as: Ganoderma lucidum.
LingZhi capsule is a traditional Chinese medicine-derived immunomodulatory agent that enhances immune function and promotes anti-tumor activity.
LingZhi capsule is a traditional Chinese medicine-derived immunomodulatory agent that enhances immune function and promotes anti-tumor activity. Used for Cancer supportive care and immunomodulation (Phase 3 indication under investigation).
-
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). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| 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 | LingZhi capsule |
|---|---|
| Also known as | Ganoderma lucidum |
| Sponsor | The University of Hong Kong |
| Drug class | Herbal immunomodulator |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
LingZhi (Ganoderma lucidum, reishi mushroom) contains bioactive polysaccharides and triterpenes that stimulate natural killer cells, macrophages, and T-cell responses. The preparation is believed to work through multiple immune pathways to support anti-cancer effects and improve quality of life in cancer patients.
Approved indications
- Cancer supportive care and immunomodulation (Phase 3 indication under investigation)
Common side effects
- Gastrointestinal disturbance
- Allergic reactions
- Headache
Key clinical trials
- A Clinical Trial to Investigate the Safety and Efficacy of Papillex® on Abnormal Cervical Cells Caused by HPV. (NA)
- Assessing the Impact of Herbal Supplement on Fatigue and Disease Activity in SLE: Results From an 8-Week Randomized Trial (NA)
- PsP Ganoderma Lucidum Supplementation and Biomarker Changes in Smokers (NA)
- Clinical Trial: Rapid Immune Modulating Effects (NA)
- Effects of Botanical Microglia Modulators in Gulf War Illness (NA)
- RCT of Efficacy and Safety of CP003 on CFS/ME or Post-COVID Fatigue (PHASE2, PHASE3)
- Mushrooms, Mood and Mental Wellbeing in Gen Z Women (NA)
- Tumor Nutritional Therapy in the First-line Treatment of Stage IV NSCLC (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:
- LingZhi capsule CI brief — competitive landscape report
- LingZhi capsule updates RSS · CI watch RSS
- The University of Hong Kong portfolio CI
Frequently asked questions about LingZhi capsule
What is LingZhi capsule?
How does LingZhi capsule work?
What is LingZhi capsule used for?
Who makes LingZhi capsule?
Is LingZhi capsule also known as anything else?
What drug class is LingZhi capsule in?
What development phase is LingZhi capsule in?
What are the side effects of LingZhi capsule?
Related
- Drug class: All Herbal immunomodulator drugs
- Manufacturer: The University of Hong Kong — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Cancer supportive care and immunomodulation (Phase 3 indication under investigation)
- Also known as: Ganoderma lucidum
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing