pivmecillinam
Small moleculeapproved
Approved
Apr 24, 2024
Pivmecillinam (INN), or amdinocillin pivoxil (USAN), sold under the brand name Selexid and Pivya among others, is an orally active prodrug of mecillinam, an extended-spectrum penicillin antibiotic. Pivmecillinam is the pivaloyloxymethyl ester of mecillinam. — Wikipedia
Clinical trial activity
7 trials · 16 clinical orgs · 1 marketing orgs
Phase 1
0
Phase 2
3
Phase 3
2
Phase 4
4
Earliest trial started Mar 1, 2014 (NCT02083276)
Timeline
2010s
- Jan 1, 2014
Earliest Phase 2 Sponsor(trial)
2020s
- Jan 1, 2022
Earliest Phase 3 Sponsor(trial)
- Apr 24, 2024
UTILITY THERAP — Earliest FDA Approval
- Apr 24, 2024
UTILITY THERAP — NDA Organization
Indications
Approved for
Mechanism of action
- Penicillin-binding protein 2INHIBITOR
Q53724 inhibitor
Bacterial penicillin-binding protein 2 inhibitor
Approval history
- approvedPriority reviewApr 24, 2024
Chemistry & pharmacology
Loading structure…
SMILES
CC(C)(C)C(=O)OCOC(=O)[C@@H]1N2C(=O)[C@@H](/N=C/N3CCCCCC3)[C@H]2SC1(C)C- Mol. weight
- 439.58 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Discontinued
Oral
Yes
Parenteral
No
Topical
No
Prodrug
Sources
- WikipediaPivmecillinam ↗
- ChEMBLCHEMBL1650818 ↗
Also known as
- amdinocillin, pivaloyloxymethyl ester
- amdinocillin, pivaloyloxymethyl ester
- amdinocillin pivoxil
- amdinocillin pivoxil
- amdinocillin pivoxil
- amdinocillin pivoxil
- coactabs
- coactabs
- pivamdinocillin
- pivmecilinamo
- pivmecilinamo
- pivmecillinam
- pivmecillinam
- pivmecillinam
- pivmecillinam
- pivmecillinam
- pivmecillinam
- pivmecillinam
- pivmecillinam
- pivmecillinam hcl
- pivmecillinam hcl
- pivmecillinam hcl
- pivmecillinam hydrochloride
- pivmecillinam hydrochloride
- pivmecillinamum
- pivmecillinamum
- ro-109071
- ro-109071
- selexid
- selexid
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07236944 | Phase 4 | Nov 30, 2025 | The Swedish Research Council, Uppsala University |
| NCT05224401 | Phase 3 | Jan 10, 2023 | Lund University |
| NCT05545137 | Phase 3 | Dec 30, 2022 | Greenpine Pharma Group Co.,Ltd., Shandong University |
| NCT04959331 | Phase 4 | Nov 2, 2021 | Balearic Islands Health Service (Ibsalut), Gerencia de Atención Primaria, Madrid, Instituto de Investigación Sanitaria Aragón, Jordi Gol i Gurina Foundation |
| NCT03228108 | Phase 4 | Oct 31, 2017 | Radboud University, ZonMw: The Netherlands Organisation for Health Research and Development |
| NCT03282006 | Phase 4 | Sep 29, 2017 | Sykehuset i Vestfold HF, The Hospital of Vestfold, University of Oslo |
| NCT02083276 | Phase 2 | Mar 1, 2014 | Helse Møre og Romsdal HF, Osaka University, University of Oslo |
Showing 7 of 7 trials
Page 1 / 1
Organizations
Research & Development (16)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| University of Oslo | Academic/Hospital | 2 | 0 | 2 | 2014 |
| Balearic Islands Health Service (Ibsalut) | Academic/Hospital | 1 | 0 | 1 | 2021 |
| Gerencia de Atención Primaria, Madrid | Academic/Hospital | 1 | 0 | 1 | 2021 |
| Greenpine Pharma Group Co.,Ltd. | For profit | 1 | 1 | 1 | 2022 |
| Helse Møre og Romsdal HF | Academic/Hospital | 1 | 0 | 1 | 2014 |
| Instituto de Investigación Sanitaria Aragón | Academic/Hospital | 1 | 0 | 1 | 2021 |
| Jordi Gol i Gurina Foundation | Academic/Hospital | 1 | 1 | 1 | 2021 |
| Lund University | Academic/Hospital | 1 | 1 | 1 | 2023 |
| Osaka University | Academic/Hospital | 1 | 1 | 1 | 2014 |
| Radboud University | Academic/Hospital | 1 | 1 | 1 | 2017 |
| Shandong University | Academic/Hospital | 1 | 0 | 1 | 2022 |
| Sykehuset i Vestfold HF | Academic/Hospital | 1 | 1 | 1 | 2017 |
| The Hospital of Vestfold | Academic/Hospital | 1 | 0 | 1 | 2017 |
| The Swedish Research Council | Academic/Hospital | 1 | 0 | 1 | 2025 |
| Uppsala University | Academic/Hospital | 1 | 1 | 1 | 2025 |
| ZonMw: The Netherlands Organisation for Health Research and Development | Academic/Hospital | 1 | 0 | 1 | 2017 |
16 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| UTILITY THERAP | For profit | NDA | Apr 24, 2024 |