Durlobactam
As of the edition of 20 October 2026, Durlobactam is a small molecule: marketed, first approved in 2023 (US); US protection ends in 2033.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2023
- Kind
- Small molecule
- Brand name
- Xacduro (copackaged)
- First approved
- 23 May 2023 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Entasis Therapeutics
- Registered trials
- 9, 0 stopped early
- Disease areas
- Infections; Lungs and airways
US protection
US protection ends in 2033.
The last listed US exclusivity ends in 2033. The application that gives this date is held by Entasis Therapeutics.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
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Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 1 | 0 |
| Phase 1 | 5 | 4 | 1 | 0 |
| Phase 2 | 2 | 1 | 1 | 0 |
| Phase 3 | 1 | 1 | 0 | 0 |
| All trials | 9 |
Who ran its trials
| Company | Role | Years |
|---|---|---|
| Entasis Therapeutics | Lead sponsor of trials | 2016 to now |