Drugs / UPLEGANAN
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT04865393 | Jun → Dec 2021 | impaired renal function disease | Spero Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT04868292 | Jun → Sep 2021 | — | Spero Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT03792308 | Dec 2018 → Dec 2019 | — | Spero Therapeutics | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2024-02-28 | Sperotx | Regulatory Spero Therapeutics Announces Clearance of IND for SPR206 to Treat MDR Gram-negative Bacterial Infections sperotx.com ↗ |
| 2022-02-16 | Sperotx | Results Spero Therapeutics Announces Positive Topline Results from Phase 1 Bronchoalveolar Lavage Clinical Trial of SPR206, A Novel Intravenous Next Generation Polymyxin Antibiotic for the Treatment of Multi-drug Resistant Gram-Negative Infections in the Hospital Setting sperotx.com ↗
Results showed that SPR206 was generally well-tolerated with a mean lung epithelial lining fluid (ELF) to plasma concentration ratio of 0.264, with area under the curve (AUC) from 0-8 hours used to estimate the total uptake of SPR206. |
| 2020-01-13 | Sperotx | Results Spero Reports Preliminary Findings from Phase 1 Clinical Trial of SPR206 and Plans to Advance Program with Alliance Partners Everest Medicines and the Department of Defense sperotx.com ↗
Analysis of preliminary, blinded data from the Phase 1 double-blind, placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial in healthy adult volunteers suggests that SPR206 is well-tolerated at doses that are likely to be within a therapeutic range for target MDR Gram-negative bacterial infections and has a safety profile that Spero believes supports the further development of SPR206. |
| 2018-10-11 | Sperotx | Regulatory Spero Therapeutics Receives QIDP Designation from the U.S. FDA for the Development of SPR206 sperotx.com ↗
Spero Therapeutics, Inc. (Nasdaq:SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multidrug-resistant bacterial infections, announced today that SPR206, a product candidate within Spero's Potentiator Platform, has been granted Qualified Infectious Disease Product (QIDP) designation by the U.S. Food and Drug Administration for the treatment of complicated urinary tract infections (cUTI) and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP). |
| 2018-05-23 | Sperotx | Results Spero Therapeutics Announces Positive Top-Line Data for Two Product Candidates from its Potentiator Platform sperotx.com ↗
Spero also announced results today from the IND-enabling studies of SPR206, its second product candidate from the platform, that demonstrate the potential for this agent to achieve wide therapeutic margins in the treatment of serious Gram-negative infections and are supportive of advancement into clinical development. |
All press releases naming this drug 12 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | UPLEGANAN | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314491 ↗ |
| Known as | SPR206 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03792308 ↗ |
| Modality | Other / unclassified | “SPR206 is a novel polymyxin derivative” PMID 34339267 ↗ Aug 2021 |
| Route | Intravenous | “single and multiple intravenous doses of SPR206” NCT03792308 ↗ |