sulopenem etzadroxil
Trade name: Orlynvah
Small moleculeapproved
Approved
Oct 25, 2024
Clinical trial activity
14 trials · 6 clinical orgs · 1 marketing orgs
Phase 1
8
Phase 2
5
Phase 3
4
Phase 4
0
Earliest trial started Nov 1, 2008 (NCT00759564)
Timeline
2010s
- Jan 1, 2018
Iterum Therapeutics — Earliest Phase 3 Sponsor(trial)
2020s
- Oct 25, 2024
Iterum Therapeutics — Earliest FDA Approval
- Oct 25, 2024
Iterum Therapeutics — NDA Organization
Indications
Approved for
Studied for
Mechanism of action
- Bacterial penicillin-binding proteinINHIBITOR
Bacterial penicillin-binding protein inhibitor
- D-alanyl-D-alanine carboxypeptidase DacB (dacB) ↗
- Peptidoglycan D,D-transpeptidase FtsI (ftsI) ↗
- Penicillin-binding protein 1A (mrcA) ↗
- Penicillin-binding protein 1B (mrcB) ↗
- D-alanyl-D-alanine carboxypeptidase DacA (dacA) ↗
- Peptidoglycan D,D-transpeptidase MrdA (mrdA) ↗
- D-alanyl-D-alanine carboxypeptidase DacC (dacC) ↗
- Unspecified targetUnclear
unclear
Combination products
orlynvah
with probenecid
Also known as sulopenem etzadroxil, probenecid
Approval history
- approvedOct 25, 2024
Chemistry & pharmacology
Loading structure…
SMILES
CCC(CC)C(=O)OCOC(=O)C1=C(S[C@H]2CC[S@+]([O-])C2)S[C@@H]3[C@@H]([C@@H](C)O)C(=O)N13- Mol. weight
- 477.63 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Availability
- Prescription Only
Oral
No
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL2105663 ↗
- ChEMBLCHEMBL4594246 ↗
- ChEMBLCHEMBL2029184 ↗
- ChEMBLCHEMBL1908305 ↗
Also known as
- cp 70429
- cp-70429
- cp-70429
- cp-70429
- cp-70,429
- cp-70,429
- cp-70,429
- pf-03709270
- pf-03709270
- sulopenem
- sulopenem
- sulopenem
- sulopenem
- sulopenem etzadroxil
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06733675 | Phase 1 | Jan 7, 2025 | Department of Health and Human Services, VenatoRx Pharmaceuticals, Inc. |
| NCT06665555 | Phase 1 | Nov 4, 2024 | National Institute of Allergy and Infectious Diseases (NIAID), VenatoRx Pharmaceuticals, Inc. |
| NCT05584657 | Phase 3 | Oct 18, 2022 | Iterum Therapeutics |
| NCT05488678 | Phase 1 | Oct 12, 2022 | National Institute of Allergy and Infectious Diseases (NIAID), VenatoRx Pharmaceuticals, Inc. |
| NCT05527834 | Phase 1 | Sep 13, 2022 | National Institute of Allergy and Infectious Diseases (NIAID), VenatoRx Pharmaceuticals, Inc. |
| NCT04877379 | Phase 1 | Jun 8, 2021 | National Institute of Allergy and Infectious Diseases (NIAID), VenatoRx Pharmaceuticals, Inc. |
| NCT04700787 | Phase 1 | Jan 21, 2021 | Iterum Therapeutics, University of Bern |
| NCT04243863 | Phase 1 | Jan 20, 2020 | National Institute of Allergy and Infectious Diseases (NIAID), VenatoRx Pharmaceuticals, Inc. |
| NCT03358576 | Phase 3 | Sep 18, 2018 | Iterum Therapeutics |
| NCT03357614 | Phase 3 | Sep 18, 2018 | Iterum Therapeutics |
| NCT03354598 | Phase 3 | Aug 1, 2018 | Iterum Therapeutics |
| NCT00797108 | Phase 2 | Jan 1, 2009 | Pfizer |
| NCT00759564 | Phase 1 | Nov 1, 2008 | Pfizer |
| NCT04682834 | N/A | — | Iterum Therapeutics |
Showing 14 of 14 trials
Page 1 / 1
Organizations
Research & Development (6)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Iterum Therapeutics | For profit | 6 | 6 | 3 | 2018 |
| VenatoRx Pharmaceuticals, Inc. | For profit | 6 | 6 | 1 | 2020 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Government | 5 | 0 | 1 | 2020 |
| Pfizer | For profit | 2 | 2 | 2 | 2008 |
| Department of Health and Human Services | Government | 1 | 0 | 1 | 2025 |
| University of Bern | Academic/Hospital | 1 | 0 | 1 | 2021 |
6 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Iterum Therapeutics | For profit | NDA | Oct 25, 2024 |