pentosan polysulfate sodium
Trade name: elmiron
Approved
Sep 26, 1996
Pentosan polysulfate sodium (brand name ELMIRON) is a low molecular weight heparin-like compound. It has anticoagulant and fibrinolytic effects and is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis. The mechanism of action of pentosan polysulfate sodium in interstitial cystitis is not known but was discovered, that it t binds Fibroblast growth factors (FGFs) as well as other heparin-binding growth factors. — NCATS
Clinical trial activity
12 trials · 16 clinical orgs · 1 marketing orgs
Earliest trial started Jun 1, 1999 (NCT00003825)
Timeline
1980s
- Aug 7, 1985
Orphan Drug Designation
1990s
- Sep 26, 1996
Johnson and Johnson — Earliest FDA Approval
- Sep 26, 1996
Johnson and Johnson — NDA Secondary Org
- Sep 26, 1996
Johnson and Johnson — NDA Organization
- Jan 1, 1999
Earliest Phase 3 Sponsor(trial)
2000s
- Jan 1, 2005
Earliest Phase 2 Sponsor(trial)
Indications
Approved for
Studied for
- Bipolar Disorder · Phase 2
- Cystitis · Phase 2/Phase 3
- Cystitis, Interstitial · Phase 4
- Diarrhea · Phase 3
- Enteritis · Phase 3
- Hyperlipoproteinemias · Phase 3
- Leigh Disease · Phase 2
- Lower Urinary Tract Symptoms · Phase 2
- Mycobacterium bovis · Phase 2
- Osteoarthritis, Knee · Phase 3
- Prostatitis · Phase 2
- Psychotic Disorders · Phase 2
- Schizophrenia · Phase 2
- Urinary Bladder Neoplasms · Phase 2
Mechanism of action
- Fibroblast growth factor receptor 1INHIBITOR
FGFR1 inhibitor
Mode of action not fully understood; it seems to provide a protective coating to the bladder wall
- Unspecified targetOTHER
Unknown
Mode of action not fully understood; it seems to provide a protective coating to the bladder wall
- Unspecified targetUnknown
Unknown
Mode of action not fully understood; it seems to provide a protective coating to the bladder wall
Approval history
- approvedSep 26, 1996
Chemistry & pharmacology
SMILES
CC(C)(CO)[C@@H](O)C(=O)NCCC(=O)NCCSSCCNC(=O)CCNC(=O)[C@H](O)C(C)(C)CO- Mol. weight
- 554.73 g/mol
- Lipinski Ro5
- 2 violation(s)
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- Yes
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- WikipediaPentosan polysulfate ↗
- NCATSF59P8B75R4 ↗
- ChEMBLCHEMBL2104786 ↗
- ChEMBLCHEMBL1201516 ↗
Also known as
- bis(n-pantothenylamidoethyl) disulfide
- elmiron
- elmiron
- elmiron
- elmiron
- elmiron
- elmiron
- elmiron
- fibrase
- hemoclar
- hemoclar
- lipodel
- lipodel
- liponet
- obliterol
- pantethine
- pantethine
- pantethine
- pantethine
- pantethine
- pantethine
- pantethine
- pantethine
- pantethine, 14c-labeled cpd
- pantethine, (d)-(+)-isomer
- pantetina
- panthecin
- pantomin
- pantosin
- pentosan
- pentosan
- pentosan polysulfate
- pentosan polysulfate
- pentosan polysulfate sodium
- pentosan polysulfate sodium
- pentosan polysulfate sodium
- pentosan polysulfate sodium
- pentosan polysulfate sodium
- pentosan polysulfate sodium
- pz68
- pz68
- sp54
- sp54
- sp 54
- sp 54
- xylan polysulfate
- xylan sulfate
- xylofuranan sulfate
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06990984 | Phase 2 | Oct 31, 2025 | Thiogenesis Therapeutics, Inc., University of Pennsylvania |
| NCT06917404 | Phase 3 | May 29, 2025 | Paradigm Biopharmaceuticals USA (INC) |
| NCT05245591 | Phase 2/Phase 3 (Phase 3) | Apr 29, 2022 | National Taiwan University |
| NCT04814719 | Phase 3 | Dec 24, 2021 | Northwestern University, Paradigm Biopharmaceuticals USA (INC) |
| NCT04809376 | Phase 2/Phase 3 (Phase 3) | Jun 26, 2021 | Northwestern University, Paradigm Biopharmaceuticals USA (INC) |
| NCT07184827 | Phase 3 | Oct 14, 2020 | Government of Taiwan, TCM Biotech International Corp. |
| NCT03549650 | Phase 2 | Jul 3, 2018 | Cancer Research Network, McGill University |
| NCT02930005 | Phase 2 | Aug 1, 2015 | University of Texas at Houston |
| NCT01811082 | Phase 3 | Jul 1, 2010 | Zhejiang University |
| NCT00236990 | Phase 2 | Oct 7, 2005 | Alza, McNeil |
| NCT00086684 | Phase 4 | Sep 1, 2003 | Johnson and Johnson |
| NCT00003825 | Phase 3 | Jun 1, 1999 | National Cancer Institute (NCI), Radiation Therapy Oncology Group |
Organizations
Research & Development (16)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Paradigm Biopharmaceuticals USA (INC) | For profit | 3 | 3 | 1 | 2021 |
| Northwestern University | Academic/Hospital | 2 | 0 | 1 | 2021 |
| Alza | For profit | 1 | 0 | 1 | 2005 |
| Cancer Research Network | Academic/Hospital | 1 | 0 | 1 | 2018 |
| Government of Taiwan | Government | 1 | 0 | 1 | 2020 |
| Johnson and Johnson | For profit | 1 | 1 | 1 | 2003 |
| McGill University | Academic/Hospital | 1 | 1 | 1 | 2018 |
| McNeil | For profit | 1 | 1 | 1 | 2005 |
| National Cancer Institute (NCI) | Government | 1 | 0 | 1 | 1999 |
| National Taiwan University | Academic/Hospital | 1 | 1 | 1 | 2022 |
| Radiation Therapy Oncology Group | Academic/Hospital | 1 | 1 | 1 | 1999 |
| TCM Biotech International Corp. | For profit | 1 | 1 | 1 | 2020 |
| Thiogenesis Therapeutics, Inc. | For profit | 1 | 1 | 1 | 2025 |
| University of Pennsylvania | Academic/Hospital | 1 | 0 | 1 | 2025 |
| University of Texas at Houston | Academic/Hospital | 1 | 1 | 1 | 2015 |
| Zhejiang University | Academic/Hospital | 1 | 1 | 1 | 2010 |
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Johnson and Johnson | For profit | NDA2 | Sep 26, 1996 |
| Johnson and Johnson | For profit | NDA | Sep 26, 1996 |