Drugs / XTMAB-16
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04971395 | Jun 2021 → Mar 2022 | — | Xentria, Inc. | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT07680166 | Oct 2026 → Oct 2029 expected | pulmonary sarcoidosis | Xentria, Inc. | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT05890729 | Nov 2023 → May 2029 expected | pulmonary sarcoidosis | Xentria, Inc. | Recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06169397 | Mar 2024 → Jan 2029 expected | pulmonary sarcoidosis | Xentria, Inc. | Enrolling by invitation | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2026-07-15 | Xentria, Inc. | Results Steroid-Sparing and Pulmonary Stability Across XTMAB-16 Dose Regimens in Pulmonary Sarcoidosis: Cohort-Level Findings from XTMAB-16-201 Part A xentria.com ↗
During corticosteroid withdrawal, XTMAB-16-treated participants more consistently maintained FVC stability, whereas placebo-treated participants showed FVC declines during tapering. |
| 2026-05-15 | Xentria, Inc. | Results XTMAB-16 in Sarcoidosis: First-in-Patient Study Results xentria.com ↗
In this phase 1b/2a MAD study, XTMAB-16 demonstrated a favorable safety and tolerability profile in patients with pulmonary sarcoidosis, without unexpected TNF-inhibitor class effects. |
| 2026-05-15 | Xentria, Inc. | Results Targeting TNF-α to Preserve Lung Function in Pulmonary Sarcoidosis: Results from a Phase 1b/2a Multiple-Ascending-Dose Trial of XTMAB-16 xentria.com ↗
XTMAB-16 demonstrated a favorable safety and tolerability profile in patients with pulmonary sarcoidosis. |
| 2025-05-16 | Xentria, Inc. | Results Delivering Adaptive Approaches to Pulmonary Sarcoidosis xentria.com ↗
XTMAB-16 showed a superior dose effect to the standard of care, corticosteroids, at doses comparable to therapeutic and supra-therapeutic doses; with supra-therapeutic dose of steroids being toxic and infeasible |
| 2023-11-15 | Xentria, Inc. | Regulatory Xentria's XTMAB-16 Receives Orphan Drug Designation from European Medicines Agency as First Patient Is Enrolled in Study xentria.com ↗
Xentria, Inc., a clinical-stage biotherapeutics company focused on developing therapeutics to address unmet clinical needs, today announced that its lead candidate, XTMAB-16, has been granted Orphan Drug Designation by the European Medicines Agency (EMA). |
| 2022-06-24 | Xentria, Inc. | Results Xentria Shares Initial Findings of Novel Biologic XTMAB-16’s Potential to Reduce Sarcoidosis Granuloma xentria.com ↗ |
| 2022-05-13 | Xentria, Inc. | Results XTMAB-16 Attenuates Granuloma Formation in a Human In Vitro Sarcoidosis Model xentria.com ↗
Data derived from ten consecutive patients showed that pretreatment with XTMAB-16 significantly, and dose-dependently, reduces granuloma formation in an in vitro model within the range of 1 μg/ml and 40 μg/ml. |
| 2022-03-08 | Xentria, Inc. | Results Xentria to Present Initial Preclinical Findings of XTMAB-16 at ATS 2022 International Conference xentria.com ↗
Data derived from sarcoidosis patients demonstrates XTMAB-16’s potential ability to suppress granuloma formation in the in vitro model in a dose-dependent fashion. |
| 2021-06-22 | Xentria, Inc. | Regulatory Xentria Initiates Clinical Trial for XTMAB-16 for the Treatment of Sarcoidosis xentria.com ↗ |
| 2021-03-03 | Xentria, Inc. | Regulatory Xentria Submits IND Application for XTMAB-16 in the Treatment of Sarcoidosis xentria.com ↗
Xentria Inc., a biopharmaceutical company focused on developing novel biologics and biosimilars to address unmet clinical needs, today announced that it submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) on February 26, 2021. |
| 2020-12-15 | Xentria, Inc. | Regulatory Xentria Announces FDA Orphan Drug Designation for XTMAB-16 in Sarcoidosis xentria.com ↗ |
All press releases naming this drug 14 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | XTMAB-16 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06169397 ↗ |
| Known as | KBMAB-16 | “single intravenous (IV) infusion of XTMAB-16 (formerly referred to as KBMAB-16) in normal healthy male and female participants.” NCT04971395 ↗ |
| Route | Intravenous | “single intravenous (IV) infusion of XTMAB-16 (formerly referred to as KBMAB-16) in normal healthy male and female participants.” NCT04971395 ↗ |