Overview
Bisacodyl, a diphenylmethane derivative, is a commonly used over the counter stimulant laxative for occasional constipation. Both bisacodyl and picosulfate are metabolized to the same active metabolite bis-(p-hydroxyphenyl)-pyridyl-2-methane (BHPM). Bisacodyl was patented on 25 September 1956 but has been used as a laxative since 1952.
Background
Bisacodyl, a diphenylmethane derivative, is a commonly used over the counter stimulant laxative for occasional constipation. Both bisacodyl and picosulfate are metabolized to the same active metabolite bis-(p-hydroxyphenyl)-pyridyl-2-methane (BHPM). Bisacodyl was patented on 25 September 1956 but has been used as a laxative since 1952.
Indication
Bisacodyl is indicated to relieve occasional constipation and irregularity.
Associated Conditions
- Bowel movement irregularity
- Constipation
- Occasional Constipation
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/06/08 | Phase 1 | Completed | |||
2021/12/03 | Phase 3 | Completed | |||
2021/09/02 | Not Applicable | Completed | Parc Taulí Hospital Universitari | ||
2021/06/18 | N/A | Withdrawn | |||
2021/05/26 | Not Applicable | Suspended | |||
2019/10/21 | Phase 4 | Completed | |||
2019/10/17 | Phase 4 | Completed | |||
2019/02/21 | Not Applicable | Completed | |||
2017/09/12 | Phase 4 | Completed | University Hospital, Gasthuisberg | ||
2017/07/21 | Not Applicable | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Better Living Brands, LLC | 21130-827 | ORAL | 5 mg in 1 1 | 4/29/2025 | |
| Strive Pharmaceuticals Inc. | 70692-761 | ORAL | 5 mg in 1 1 | 4/25/2025 | |
| C.B. Fleet Company, Inc. | 0132-0703 | RECTAL | 10 mg in 30 mL | 6/23/2025 | |
| TOPCO ASSOCIATES LLC | 76162-676 | ORAL | 5 mg in 1 1 | 4/26/2025 | |
| Bryant Ranch Prepack | 71335-2010 | ORAL | 5 mg in 1 1 | 3/31/2025 | |
| Meijer Distribution, Inc. | 79481-6760 | ORAL | 5 mg in 1 1 | 3/24/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| SUNNY LAXATIVE PILL | SIN06590P | ENTERIC COATED TABLET | 5 mg | 9/23/1991 | |
| DULCOLAX TABLET 5 mg | SIN02669P | ENTERIC COATED TABLET | 5.0000mg | 4/28/1989 | |
| S.L. LAXATIVE TABLET 5 mg | SIN02689P | ENTERIC COATED TABLET | 5 mg | 4/28/1989 | |
| UNILAX TABLET 5 mg | SIN03319P | ENTERIC COATED TABLET | 5 mg | 6/8/1989 | |
| BISACODYL SUPPOSITORIES 10 mg | SIN10948P | SUPPOSITORY | 10 mg | 5/25/1999 | |
| BISACODYL TABLET 5 mg | SIN03615P | ENTERIC COATED TABLET | 5 mg | 7/15/1989 | |
| DULCOLAX SUPPOSITORY 10 mg | SIN02663P | SUPPOSITORY | 10 mg | 4/28/1989 | |
| BIOLAX TABLET 5 mg | SIN08243P | ENTERIC COATED TABLET | 5 mg | 7/4/1995 | |
| BISACODYL SUPPOSITORIES 5MG | SIN14002P | SUPPOSITORY | 5.0mg | 8/22/2011 | |
| DILAX PILLS 5 mg | SIN06102P | ENTERIC COATED TABLET | 5 mg | 6/12/1991 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Bisacodyl Tablets | 国药准字H34021898 | 化学药品 | 片剂(肠溶) | 7/3/2020 | |
| Bisacodyl Enteric-coated Tablets | 国药准字H10880043 | 化学药品 | 片剂 | 5/19/2020 | |
| Bisacodyl Enteric-coated Tablets | 国药准字H13022092 | 化学药品 | 片剂 | 5/25/2020 | |
| Bisacodyl Enteric-coated Tablets | 国药准字H37022712 | 化学药品 | 片剂 | 11/9/2021 | |
| Bisacodyl Enteric-coated Tablets | 国药准字H37023011 | 化学药品 | 片剂 | 1/9/2020 | |
| Bisacodyl Enteric-coated Tablets | 国药准字H20057029 | 化学药品 | 片剂 | 4/7/2020 | |
| Bisacodyl Suppositories | 国药准字H20074197 | 化学药品 | 栓剂 | 11/1/2022 | |
| Bisacodyl Suppositories | 国药准字H20020271 | 化学药品 | 栓剂 | 2/8/2020 | |
| Bisacodyl Suppositories | 国药准字H20065455 | 化学药品 | 栓剂 | 4/15/2021 | |
| Bisacodyl Suppositories | 国药准字H19991396 | 化学药品 | 栓剂 | 5/19/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| DULCOLAX ENTERIC-COATED TAB 5MG | N/A | N/A | N/A | 12/8/1978 | |
| TINOLAX ENTERIC-COATED TABLETS 5MG | N/A | hitpharm pharmaceutical co ltd | N/A | N/A | 8/1/2017 |
| BISOLAX 5 TAB 5MG (ENTERIC COATED) | N/A | star medical supplies ltd | N/A | N/A | 7/3/1998 |
| SYNILAX SUPPOSITORY 10MG | N/A | synco (h.k.) limited | N/A | N/A | 11/14/2014 |
| SURULAC-S ENTERIC-COATED TABLETS | N/A | N/A | N/A | 1/21/2013 | |
| BISACODYL FU YUAN GASTRO-RESISTANT TABLETS 5MG | N/A | N/A | N/A | 12/9/2024 | |
| SPILAX GASTRO-RESISTANT TABLETS 5MG | N/A | N/A | N/A | 5/27/2025 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| DULCOLAX bisacodyl 10 mg suppository strip pack | 17926 | Medicine | A | 9/26/1991 | |
| BISACODYL SUPPOSITORIES 10 mg strip pack | 46400 | Medicine | A | 9/3/1993 | |
| Lax-Tab Bisacodyl 5mg tablet blister pack | 119125 | Medicine | A | 5/6/2005 | |
| NEO BISACODYL 5mg tablets blister pack | 360021 | Medicine | A | 4/7/2021 | |
| APOHEALTH BISACODYL LAXATIVE bisacodyl 5 mg tablet blister pack | 267256 | Medicine | A | 1/18/2016 | |
| CHEMISTS' OWN LAXATIVE FOR CONSTIPATION RELIEF bisacodyl 5 mg tablet blister pack | 300565 | Medicine | A | 3/8/2018 | |
| PHARMACY HEALTH BISACODYL LAXATIVE 5 mg enteric coated tablet blister pack | 292358 | Medicine | A | 8/2/2017 | |
| DULCOLAX bisacodyl 5 mg tablet blister pack | 155405 | Medicine | A | 9/25/2008 | |
| LAXACTIVE bisacodyl 5 mg tablet blister pack | 466447 | Medicine | A | 10/30/2024 | |
| BISALAX bisacodyl 5mg enteric coated tablet bottle | 231318 | Medicine | A | 12/3/2014 |