18 and older, any sex, with Skin and Subcutaneous Tissue Bacterial Infections or Gram-Positive Bacterial Infections. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Early Clinical Response at the Early Assessment (EA) Visit in the Intent-to-Treat (ITT) PopulationPrimary· 48 to 72 hours after the first dose of study treatment
Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment vis
Responder
Group
Value
95% CI
TNP-2092
61
Vancomycin
27
Nonresponder
Group
Value
95% CI
TNP-2092
4
Vancomycin
3
Indeterminate
Group
Value
95% CI
TNP-2092
15
Vancomycin
10
Early Clinical Response at the Early Assessment Visit in the Modified Intent-to-Treat (mITT) PopulationPrimary· 48 to 72 hours after the first dose of study treatment
Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment vis
Responder
Group
Value
95% CI
TNP-2092
60
Vancomycin
27
Nonresponder
Group
Value
95% CI
TNP-2092
4
Vancomycin
3
Indeterminate
Group
Value
95% CI
TNP-2092
14
Vancomycin
10
Early Clinical Response at the Early Assessment Visit in the Micro-Intent-to-Treat (Micro-ITT) PopulationPrimary· 48 to 72 hours after the first dose of study treatment
Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment vis
Responder
Group
Value
95% CI
TNP-2092
41
Vancomycin
19
Nonresponder
Group
Value
95% CI
TNP-2092
3
Vancomycin
2
Indeterminate
Group
Value
95% CI
TNP-2092
7
Vancomycin
8
Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the mITT PopulationSecondary· 7 to 14 days after the end of study treatment
At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) partici
Group
Value
95% CI
TNP-2092
62
Vancomycin
31
TNP-2092
2
Vancomycin
3
TNP-2092
14
Vancomycin
6
Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the Micro-ITT PopulationSecondary· 7 to 14 days after the end of study treatment
At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) partici
Group
Value
95% CI
TNP-2092
40
Vancomycin
23
TNP-2092
2
Vancomycin
1
TNP-2092
9
Vancomycin
5
Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the mITT PopulationSecondary· After a minimum of 7 days up to 14 days of study treatment
At the EOT Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) partici
Group
Value
95% CI
TNP-2092
68
Vancomycin
31
TNP-2092
2
Vancomycin
3
TNP-2092
8
Vancomycin
6
Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the Micro-ITT PopulationSecondary· After a minimum of 7 days up to 14 days of study treatment
At the EOT Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) partici
Group
Value
95% CI
TNP-2092
45
Vancomycin
23
TNP-2092
2
Vancomycin
1
TNP-2092
4
Vancomycin
5
AUC0-12h After First InfusionSecondary· 0 to 12 hours post-dose
Partial area under the concentration versus time curve from time zero to time 12 hours.
Group
Value
95% CI
TNP-2092
135000
± 38200
AUC0-12h After Last InfusionSecondary· 0 to 12 hours post-dose
Partial area under the concentration versus time curve from time zero to time 12 hours
Group
Value
95% CI
TNP-2092
159000
± 74200
Cmax After Last InfusionSecondary· 57 to 60 minutes, 1.5 to 3 hours, 4 to 6 hours, 12 hours, after the last infusion
Maximum observed concentration
Group
Value
95% CI
TNP-2092
38500
± 13400
Cmax After First InfusionSecondary· 57 to 60 minutes, 1.5 to 3 hours, 4 to 6 hours, 12 hours, after the first infusion
Maximum observed concentration
Group
Value
95% CI
TNP-2092
37500
± 13500
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were assessed from the first day of study treatment (day 1) to long-term follow-up visit(20 to 25 days after end of treatment), A Serious Adverse event (SAE) will be followed until resolution, stabilization, the event is otherwise explained, or the participant is lost to follow-up..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to evaluate safety, tolerability, pharmacokinetic characteristics and efficacy of TNP-2092 in adults with ABSSSI suspected or confirmed to be caused by gram-positive pathogens.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04294862 — Tissue Distribution, Pharmacokinetics, Safety, and Tolerability After a Single Dose of TNP-2092 in Participants Undergoi
· Phase 1
· completed
Other TenNor Therapeutics Limited trials
Trials by the same sponsor.
NCT05074134 — Absorption, Metabolism, and Excretion Study of [14C]-TNP-2092
· Phase 1
· completed
NCT04294862 — Tissue Distribution, Pharmacokinetics, Safety, and Tolerability After a Single Dose of TNP-2092 in Participants Undergoi
· Phase 1
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by TenNor Therapeutics Limited
Last refreshed: 1 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03964493.