Last reviewed 2026-06-02 · How we verify

Berberine plus Bezafibrate

University of Guadalajara · Phase 3 active Small molecule Under review Quality 0/100

Berberine plus Bezafibrate is a Combination therapy: alkaloid + fibrate Small molecule drug developed by University of Guadalajara. It is currently in Phase 3 development for Dyslipidemia with metabolic dysfunction, Type 2 diabetes with lipid abnormalities. Also known as: Berberine, bezafibrate.

Berberine and bezafibrate work together to improve lipid metabolism and glucose control through alkaloid and fibrate mechanisms.

Berberine plus Bezafibrate has been studied in a clinical trial for the treatment of mixed dyslipidemia. Berberine and Bezafibrate both act as small molecule agonists of the peroxisome proliferator-activated receptor.

Likelihood of approval

56.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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).
Cardiovascular Phase 3 risk -2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	Berberine plus Bezafibrate
Also known as	Berberine, bezafibrate
Sponsor	University of Guadalajara
Drug class	Combination therapy: alkaloid + fibrate
Target	AMPK (berberine); PPAR-α/γ (bezafibrate)
Modality	Small molecule
Therapeutic area	Cardiovascular, Metabolic/Endocrinology
Phase	Phase 3

Mechanism of action

Berberine is a plant alkaloid that activates AMP-activated protein kinase (AMPK) and improves insulin sensitivity and lipid profiles. Bezafibrate is a peroxisome proliferator-activated receptor (PPAR) agonist that reduces triglycerides and improves HDL cholesterol. The combination targets multiple metabolic pathways to address dyslipidemia and glucose dysregulation.

Approved indications

Dyslipidemia with metabolic dysfunction
Type 2 diabetes with lipid abnormalities

Common side effects

Gastrointestinal disturbance (berberine)
Myalgia or muscle pain (fibrate)
Elevated liver enzymes
Hyperuricemia (fibrate)

Key clinical trials

Bezafibrate Plus Berberine in Mixed Dyslipidemia (PHASE3)

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:

Berberine plus Bezafibrate CI brief — competitive landscape report
Berberine plus Bezafibrate updates RSS · CI watch RSS
University of Guadalajara portfolio CI

Frequently asked questions about Berberine plus Bezafibrate

What is Berberine plus Bezafibrate?

Berberine plus Bezafibrate is a Combination therapy: alkaloid + fibrate drug developed by University of Guadalajara, indicated for Dyslipidemia with metabolic dysfunction, Type 2 diabetes with lipid abnormalities.

How does Berberine plus Bezafibrate work?

Berberine and bezafibrate work together to improve lipid metabolism and glucose control through alkaloid and fibrate mechanisms.

What is Berberine plus Bezafibrate used for?

Berberine plus Bezafibrate is indicated for Dyslipidemia with metabolic dysfunction, Type 2 diabetes with lipid abnormalities.

Who makes Berberine plus Bezafibrate?

Berberine plus Bezafibrate is developed by University of Guadalajara (see full University of Guadalajara pipeline at /company/university-of-guadalajara).

Is Berberine plus Bezafibrate also known as anything else?

Berberine plus Bezafibrate is also known as Berberine, bezafibrate.

What drug class is Berberine plus Bezafibrate in?

Berberine plus Bezafibrate belongs to the Combination therapy: alkaloid + fibrate class. See all Combination therapy: alkaloid + fibrate drugs at /class/combination-therapy-alkaloid-fibrate.

What development phase is Berberine plus Bezafibrate in?

Berberine plus Bezafibrate is in Phase 3.

What are the side effects of Berberine plus Bezafibrate?

Common side effects of Berberine plus Bezafibrate include Gastrointestinal disturbance (berberine), Myalgia or muscle pain (fibrate), Elevated liver enzymes, Hyperuricemia (fibrate).

What does Berberine plus Bezafibrate target?

Berberine plus Bezafibrate targets AMPK (berberine); PPAR-α/γ (bezafibrate) and is a Combination therapy: alkaloid + fibrate.

Drug class: All Combination therapy: alkaloid + fibrate drugs
Target: All drugs targeting AMPK (berberine); PPAR-α/γ (bezafibrate)
Manufacturer: University of Guadalajara — full pipeline
Therapeutic area: All drugs in Cardiovascular, Metabolic/Endocrinology
Indication: Drugs for Dyslipidemia with metabolic dysfunction
Indication: Drugs for Type 2 diabetes with lipid abnormalities
Also known as: Berberine, bezafibrate

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing