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Kothala Himbutu Biscuit
Kothala Himbutu Biscuit is a Herbal alpha-glucosidase inhibitor Small molecule drug developed by Rajarata University, Sri Lanka. It is currently in Phase 3 development for Type 2 diabetes mellitus, Impaired fasting glucose / prediabetes. Also known as: Biscuit contining Salacia reticulata extract, Kothala Himbutu Biscuit manufactured by Ceylon Biscuits Ltd, Munchee Kothala Himbutu biscuit.
Kothala Himbutu (Salacia reticulata) extract in biscuit form modulates postprandial glucose levels and may improve insulin sensitivity through inhibition of intestinal alpha-glucosidase enzymes.
Kothala Himbutu (Salacia reticulata) extract in biscuit form modulates postprandial glucose levels and may improve insulin sensitivity through inhibition of intestinal alpha-glucosidase enzymes. Used for Type 2 diabetes mellitus, Impaired fasting glucose / prediabetes.
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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 | Kothala Himbutu Biscuit |
|---|---|
| Also known as | Biscuit contining Salacia reticulata extract, Kothala Himbutu Biscuit manufactured by Ceylon Biscuits Ltd, Munchee Kothala Himbutu biscuit |
| Sponsor | Rajarata University, Sri Lanka |
| Drug class | Herbal alpha-glucosidase inhibitor |
| Target | Alpha-glucosidase; possibly GLP-1 pathway |
| Modality | Small molecule |
| Therapeutic area | Endocrinology / Diabetes |
| Phase | Phase 3 |
Mechanism of action
Kothala Himbutu is a traditional Ayurvedic plant whose active constituents (salacinol and related compounds) inhibit alpha-glucosidase and other carbohydrate-metabolizing enzymes in the small intestine, slowing glucose absorption and reducing postprandial blood glucose spikes. This mechanism may also enhance insulin secretion and improve overall glycemic control in metabolic disorders.
Approved indications
- Type 2 diabetes mellitus
- Impaired fasting glucose / prediabetes
Common side effects
- Gastrointestinal disturbance (bloating, flatulence, diarrhea)
- Abdominal discomfort
Key clinical trials
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:
- Kothala Himbutu Biscuit CI brief — competitive landscape report
- Kothala Himbutu Biscuit updates RSS · CI watch RSS
- Rajarata University, Sri Lanka portfolio CI
Frequently asked questions about Kothala Himbutu Biscuit
What is Kothala Himbutu Biscuit?
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What is Kothala Himbutu Biscuit used for?
Who makes Kothala Himbutu Biscuit?
Is Kothala Himbutu Biscuit also known as anything else?
What drug class is Kothala Himbutu Biscuit in?
What development phase is Kothala Himbutu Biscuit in?
What are the side effects of Kothala Himbutu Biscuit?
What does Kothala Himbutu Biscuit target?
Related
- Drug class: All Herbal alpha-glucosidase inhibitor drugs
- Target: All drugs targeting Alpha-glucosidase; possibly GLP-1 pathway
- Manufacturer: Rajarata University, Sri Lanka — full pipeline
- Therapeutic area: All drugs in Endocrinology / Diabetes
- Indication: Drugs for Type 2 diabetes mellitus
- Indication: Drugs for Impaired fasting glucose / prediabetes
- Also known as: Biscuit contining Salacia reticulata extract, Kothala Himbutu Biscuit manufactured by Ceylon Biscuits Ltd, Munchee Kothala Himbutu biscuit
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing