Last reviewed · How we verify
Hibiscus Sabdariffa
Hibiscus Sabdariffa is a Biologic drug developed by Ain Shams University. It is currently in Phase 1 development.
Hibiscus sabdariffa is being studied as a potential intervention for reducing emotional eating, as well as for its effects on overweight or obesity, hormonal changes, and food cravings. The beverage form of Hibiscus sabdariffa is being compared to a placebo in clinical trials to assess its efficacy.
-
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 | Hibiscus Sabdariffa |
|---|---|
| Sponsor | Ain Shams University |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- CoHort of Patients to Identify Biological and Imaging markerS of CardiovascUlar Outcomes in Stroke - HIBISCUS-STROKE II (NA)
- Evaluation of a Nutritional Intervention With Dietary Supplements in People Who Have Recently Lost Weight: Effects on Body Composition, Emotional Health, and Gut Microbiota (NA)
- Postprandial Effect of Isocaloric Challenge Meals Enriched With Indigenous Fruits and Vegetables on Glucose Metabolism in Individuals With Type 2 Diabetes in Wakiso District, Uganda (NA)
- A Study of Etavopivat in Adults and Adolescents With Sickle Cell Disease (HIBISCUS) (PHASE3)
- Pilot Trial of Hibiscus Drink During Pregnancy (PTHDDP) (NA)
- Effects of Coffee Versus Hibiscus Tea Consumption During Prolonged Sitting on Blood Pressure and Heart Rate (NA)
- Cranberry, Hibiscus, and Vitamin C Extracts Versus Placebo in Latency of Premature Rupture of Membranes. (NA)
- Efficacy of Satisens® in Reducing Emotional Eating (NA)
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:
- Hibiscus Sabdariffa CI brief — competitive landscape report
- Hibiscus Sabdariffa updates RSS · CI watch RSS
- Ain Shams University portfolio CI
Frequently asked questions about Hibiscus Sabdariffa
What is Hibiscus Sabdariffa?
Who makes Hibiscus Sabdariffa?
What development phase is Hibiscus Sabdariffa in?
Related
- Manufacturer: Ain Shams University — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing