Market atlas / AMPK / biguanide / Berberine

Berberine (AMPK activator)

traditional-to-validatedsmall-moleculeampk-activationmetabolic● hba1c● ldl

Stage by geography

signalpreclinfirst-in-humanRCTapprovedreal-worldconsumerUSCNIL+1 stages

MarketsUS United States FDAUK United Kingdom MHRA / NICECN China NMPAIN India CDSCOJP Japan PMDACH Switzerland SwissmedicSG Singapore HSAIL Israel Ministry of HealthKR South Korea MFDS

What each market approved it for

Market	Stage	Since	Indication / class / form
US	consumer	not dated	not published
CN	approved	2025-08-05	not published
IL	RCT	not dated	not published

China registers · NMPA

What each NMPA register actually approved. Reference approval NMPA H43021886. Domestic generics vs imported originator.

809domestic approvals

Forms listed: 1
Product: Berberine Hydrochloride and Trimethoprim Tablets
Form: tablet
Strength: per tablet: berberine hydrochloride0.1g,trimethoprim0.05g
Holder: Hunan Zhengqing Pharmaceutical Group
Origin: China
Approved: 2025-08-05
Approval no: NMPA H43021886

Biomarker trends

no biomarker readings yet

Studies

The studies on Berberine, what they found, in whom and how strongly, are on its evidence page, each linked to its source.

What the trials measure

Registered primary outcomes this development's trials are powered on, commonest first (ClinicalTrials.gov). What is measured, across markets.

Registered primary endpoint	Markets measuring it
Change in LDL Cholesterol	US
Change in Hemoglobin A1c	US
Number of Participants With Clinical Toxicity Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse…	US
Number of Participants With Organ Toxicity Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse…	US
Berberine	US
Dihydroberberine 200	US
Dihydroberberine 100	US
Glucose	US
Insulin	US
Percentage of patients reaching clinical response after initiation of therapy.	IL

Connections

Trajectory

2016

MarketUS: first-in-human (early clinical (phase 1))

NCT02365480 · machine-extracted

2017

Relatedshares a mechanism with Metformin

NCT03281096 · machine-extracted

2017

ProfileBerberine (AMPK activator)

NCT03281096 · machine-extracted

2025

MarketCN: approved-other (NMPA-approved (domestic))

NMPA:NMPA H43021886 · machine-extracted

2026

MarketUS: consumer (US dietary supplement (DSHEA), not FDA-approved as a drug)

DSLD:333404 · machine-extracted

2026

MarketIL: rct (clinical trials (highest phase 2))

NCT05596214 · machine-extracted

Get into the weeds: raw observations + provenance

berb_us_trial  2026-06-29  kind=geography_stage  verify=M
   Berberine: US early-phase trials [NCT02365480]
   source NCT02365480  https://clinicaltrials.gov/study/NCT02365480

berb_edge_metf  2026-06-29  kind=edge  verify=M
   both AMPK activators (berberine is often called plant-derived metformin)
   source NCT03281096  https://clinicaltrials.gov/study/NCT03281096

berb_facets  2026-06-29  kind=facets  verify=M
   Berberine facets
   source NCT03281096  https://clinicaltrials.gov/study/NCT03281096

berb_cn  2026-06-29  kind=geography_stage  verify=M
   NMPA-approved in China (berberine): 809 domestic approval(s) (e.g. Berberine Hydrochloride and Trimethoprim Tablets, per tablet: berberine hydrochloride0.1g,trimethoprim0.05g, Hunan Zhengqing Pharmaceutical Group, China). Reference NMPA H43021886.
   source NMPA:NMPA H43021886  https://www.nmpa.gov.cn/datasearch/home-index.html

berb_us_consumer  2026-06-29  kind=geography_stage  verify=M
   Berberine sold as a US dietary supplement
   source DSLD:333404  https://dsld.od.nih.gov/label/333404

ctsearch__IL__dev_berberine  2026-07-10  kind=geography_stage  verify=M
   berberine: 1 registered trial(s) in IL, highest phase 2 [NCT05596214]
   source NCT05596214  https://clinicaltrials.gov/study/NCT05596214