IBD Research Resource Center

Drug ID:	Drug11
Drug Name:	Berberine
CID:	2353
DrugBank ID:	DB04115
Modality:	Small Molecule
Groups:	experimental
US Approved:	NO
Other Approved:	NO
Identifier:	NCT02962245
Molecular Formula:	C20H18NO4+
Molecular Weight:	336.4 g/mol
Isomeric SMILES:	COC1=C(C2=C[N+]3=C(C=C2C=C1)C4=CC5=C(C=C4CC3)OCO5)OC
Synonyms:	berberine; 2086-83-1; Umbellatine; Berberin; Berbericine; Majarine; Thalsine; Umbellatin; Berberone; Benzo[g]-1,3-benzodioxolo[5,6-a]quinolizinium, 5,6-dihydro-9,10-dimethoxy-
Phase 0:	2
Phase 1:	4
Phase 2:	15
Phase 3:	15
Phase 4:	21
Description:	An alkaloid from Hydrastis canadensis L., Berberidaceae. It is also found in many other plants. It is relatively toxic parenterally, but has been used orally for various parasitic and fungal infections and as antidiarrheal. [PubChem]

Molecular Structure

Knowledge Graph

dtID	CID	Compound Name	Gene ID	Gene Name	Species	PubMed IDs	Action
dt90	2353	Berberine	7124	TNF	Rattus norvegicus (Norway rat)	25600690	Berberine inhibits the reaction [mercuric chloride results in increased expression of TNF protein]
dt91	2353	Berberine	7150	TOP1	Homo sapiens (human)	23747414	Berberine results in decreased activity of TOP1 protein
dt92	2353	Berberine	7153	TOP2A	Homo sapiens (human)	23747414	TOP2A protein affects the susceptibility to berberine\|top2a protein affects the reaction [berberine results in increased expression of H2AX protein modified form]
dt93	2353	Berberine	7157	TP53	Homo sapiens (human)	26712469	Berberine results in increased phosphorylation of and results in increased acetylation of TP53 protein\|[berberine co-treated with niacinamide] results in increased expression of and results in increased acetylation of TP53 protein
dt94	2353	Berberine	7157	TP53	Homo sapiens (human)	20656010	Berberine results in increased expression of TP53 mrna\|berberine results in increased expression of TP53 protein
dt95	2353	Berberine	7186	TRAF2	Mus musculus (house mouse)	30240693	Berberine inhibits the reaction [[lipopolysaccharide, escherichia coli O111 B4 co-treated with TNF protein] results in increased secretion of TRAF2 protein]\|berberine inhibits the reaction [[lipopolysaccharide, escherichia coli O111 B4 co-treated with TNF
dt96	2353	Berberine	6737	TRIM21	Homo sapiens (human)	36822301	Berberine promotes the reaction [IGF2BP3 protein binds to TRIM21 protein]
dt97	2353	Berberine	100131187	TSTD1	Homo sapiens (human)	27311644	Berberine results in increased expression of TSTD1 mRNA
dt98	2353	Berberine	7319	UBE2A	Homo sapiens (human)	27311644	Berberine results in decreased expression of UBE2A mRNA
dt99	2353	Berberine	7320	UBE2B	Homo sapiens (human)	27311644	Berberine results in decreased expression of UBE2B mRNA

No data available

Phase Distribution

Phase Description

Phase 0: Exploratory trials to assess drug behavior in humans
Phase 1: Safety trials to determine safe dosage range
Phase 2: Efficacy trials to evaluate therapeutic effects
Phase 3: Large-scale trials to confirm efficacy and safety
Phase 4: Post-marketing surveillance for long-term safety and efficacy

Trial ID	Title	Phase	Status	Sponsor	Indications	Interventions
NCT02962245	Efficacy of Treatment With Berberine to Maintain Remission in Ulcerative Colitis	PHASE4	WITHDRAWN	Xijing Hospital of Digestive Diseases	Ulcerative Colitis	DRUG: berberine\|DRUG: regular treatment	Details
ChiCTR2400083224	A clinical trial to evaluate the relationship between nitric oxide content in type 3 natural lymphocytes and severity of enteritis and response to drug intervention in patients with inflammatory bowel disease	Not Available	Not Recruiting	Peking University Third Hospital	Inflammatory Bowel Disease	Trial group:Berberine hydrochloride tablets mesa…	Details
NCT02365480	Berberine Chloride in Preventing Colorectal Cancer in Patients With Ulcerative Colitis in Remission	PHASE1	COMPLETED	National Cancer Institute (NCI)	Ulcerative Colitis	DRUG: Berberine Chloride\|OTHER: Laboratory Biomar…	Details
NCT04985968	The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis	PHASE3	TERMINATED	InDex Pharmaceuticals	Ulcerative Colitis	DRUG: Cobitolimod 250 mg\|DRUG: Cobitolimod 500 mg…	Details
NCT06681181	A First-time in Human (FTIH) Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK4528287 in Healthy Participants	PHASE1	RECRUITING	GlaxoSmithKline	Colitis, Ulcerative	DRUG: GSK4528287\|DRUG: Placebo	Details
NCT05992142	ChAracterizing the Remission Status in Patients With Ulcerative Colitis Treated by 5-ASA	PHASE4	COMPLETED	Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW	Ulcerative Colitis	DRUG: 5-ASA	Details
NCT00787202	A Study To Investigate The Safety And Efficacy Of CP- 690,550 In Patients With Moderate And Severe Ulcerative Colitis.	PHASE2	COMPLETED	Pfizer	Ulcerative Colitis	DRUG: CP- 690 550\|DRUG: CP- 690 550\|DRUG: CP- 690…	Details
NCT06321887	EffiCacy and sAfEty of Low doSe orAl iRon for Anaemia in IBD	PHASE3	RECRUITING	Liverpool University Hospitals NHS Foundation Trust	Inflammatory Bowel Disease\|Iron Deficiency Anemia	DRUG: Ferrous fumarate syrup 2.5ml/70mg (22.5mg e…	Details
NCT00207688	A Long Term Safety Study of Infliximab (Remicade) in in Ulcerative Colitis Patients	None	COMPLETED	Janssen Research & Development, LLC	Ulcerative Colitis	DRUG: Infliximab 5 mg/kg\|DRUG: Infliximab 10 mg/k…	Details
NCT04677179	A Study of LY3471851 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC)	PHASE2	TERMINATED	Nektar Therapeutics	Colitis, Ulcerative	DRUG: LY3471851\|DRUG: Placebo	Details
NCT02958865	Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis	PHASE2	COMPLETED	Pfizer	Ulcerative Colitis	DRUG: PF-06651600 or Placebo\|DRUG: PF-06700841 or…	Details
NCT03943550	Double-Blinded, Placebo-Controlled Phase 1b Study for Safety, PK, Efficacy, PD of RO7049665 in Participants With Ulcerative Colitis (UC)	PHASE1	TERMINATED	Hoffmann-La Roche	Ulcerative Colitis	DRUG: RO7049665\|DRUG: Placebo	Details
NCT02840721	Safety, Efficacy, and Tolerability Study of PF-06480605 in Subjects With Moderate to Severe Ulcerative Colitis.	PHASE2	COMPLETED	Telavant, Inc.	Colitis, Ulcerative	DRUG: PF-06480605	Details
NCT04133194	Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis	PHASE4	RECRUITING	Flemming Bendtsen	Ulcerative Colitis	DRUG: Mesalazine\|DRUG: Mesalazine	Details
NCT01465763	A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe Ulcerative Colitis	PHASE3	COMPLETED	Pfizer	Ulcerative Colitis	DRUG: tofacitinib\|DRUG: Placebo	Details
NCT06636656	A Study to Test Whether BI 3032950 Helps People With Ulcerative Colitis	PHASE2	RECRUITING	Boehringer Ingelheim	Ulcerative Colitis	DRUG: BI 3032950 intravenous (Part A)\|DRUG: BI 30…	Details
NCT04996797	A Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Moderately to Severely Active Ulcerative Colitis (MK-7240-005)	PHASE2	ACTIVE_NOT_RECRUITING	Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	Ulcerative Colitis	DRUG: Tulisokibart\|DEVICE: Companion Diagnostic (…	Details
NCT01458951	A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis	PHASE3	COMPLETED	Pfizer	Ulcerative Colitis	DRUG: tofacitinib\|DRUG: Placebo	Details
NCT04499495	Assessment of 5-Aminosalicylic Acid Prescription Patterns and Treatment Outcomes in Patients With Ulcerative Colitis in Korea	None	COMPLETED	Ferring Pharmaceuticals	Ulcerative Colitis	OTHER: PENTASA (mesalamine/ 5-Aminosalicylic acid…	Details
NCT01959282	A Study of Safety and Effectiveness of JNJ-54781532 in Patients With Moderately to Severely Active Ulcerative Colitis	PHASE2	COMPLETED	Janssen Research & Development, LLC	Colitis, Ulcerative	DRUG: Placebo\|DRUG: JNJ-54781532 25 mg once daily…	Details

Disease ID	Disease Name	Definition	Category	Related Drugs	Mechanism
No data available

Strategy ID	Therapeutic Strategy	Synonyms	Related Drugs	Mechanism
S01	Anti-inflammatory	inflammatory	5-Aminosalicylates (5-ASAs); corticosteroids	Crohn's disease and ulcerative colitis are the two main com…	Details
S06	Anti-fibrosis	fibrosis; tissue remodelling	GS-5745; STNM01	Tissue remodelling and destruction in patients with IBD is …	Details
S07	Blockade of cytokine	Cytokine signalling	apremilast; roflumilast; filgotinib; tofacitinib; ABT494; ABT-874; ustekinumab; isankizumab; LY-2525623; AMG139; MEDI2079; guselkumab	Various T-cell subsets, their differentiation pathways and …	Details