Drugs / TNX-1500
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial · 1 met primary | ||||||
| Phase 1 | NCT07473752 | Jul 2023 → Feb 2024 | — | Tonix Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 21 trial | ||||||
| Phase 2 | NCT07204080 | Jul 2026 → Sep 2028 expected | chronic transplant rejection, disease related to solid organ transplantation, immunodeficiency disease | Ayman Al Jurdi, MD | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2026-05-27 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Announces Publication of Phase 1 Clinical Data of TNX-1500, an Fc-Modified anti-CD40L (CD154) Monoclonal Antibody, in the Peer-Reviewed Journal of Clinical Immunology tonixpharma.com ↗
Phase 1 data support TNX-1500 as a potentially first-in-class, best-in-class, third-generation anti-CD40L monoclonal antibody for the prevention of kidney transplant rejection |
| 2025-10-14 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Presented an Update on Fc-modified anti-CD40L mAb, TNX-1500, at the 61st Annual Congress of the Japan Society for Transplantation tonixpharma.com ↗ |
| 2025-05-12 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Reports First Quarter 2025 Financial Results and Operational Highlights tonixpharma.com ↗
Announced positive topline results from Phase 1 study of TNX-1500, a next generation anti-CD40L mAb candidate in development for prevention of kidney transplant rejection and treatment of autoimmune disorders |
| 2025-03-18 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results and Operational Highlights tonixpharma.com ↗
Announced positive topline results from Phase 1 study of TNX-1500, a next generation anti-CD40L mAb candidate for prevention of kidney transplant rejection and treatment of autoimmune diseases |
| 2025-02-06 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Announces Positive Topline Results from Phase 1 Trial for TNX-1500, a Next Generation anti-CD40L mAb Candidate for Prevention of Kidney Transplant Rejection and Treatment of Autoimmune Diseases tonixpharma.com ↗
TNX-1500 was generally well-tolerated with a favorable safety profile |
| 2024-06-06 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Announces Two Oral Presentations and One Poster Presentation Involving TNX-1500 (Fc-modified humanized anti-CD40L mAb) at the American Transplant Congress 2024 tonixpharma.com ↗
TNX-1500 displays potential as a monotherapy or combination therapy to prevent rejection in organ transplantation in allograft and xenograft animal models |
| 2024-03-05 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Announces Translation of Preclinical Pharmacokinetic Parameters of TNX-1500 (Fc-modified humanized anti-CD40L mAb) Supports Monthly i.v. Dosing in Humans tonixpharma.com ↗
The predicted human half-life for TNX 1500 is 23.8 days (range of 18.3 to 27.6 days) which supports monthly dosing. |
| 2023-10-30 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Announces New Data Involving TNX-1500 (Fc-modified dimeric anti-CD40L mAb) in Heart Xenotransplantation in Animal Models at the ACS Clinical Congress and IPITA-IXA-CTRMS Joint Congress tonixpharma.com ↗ |
| 2023-10-18 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Announces Publication of Data in the Journal Nature Involving TNX-1500 (Fc-modified dimeric anti-CD40L mAb) for the Prevention of Rejection in Kidney Xenotransplantation in Animal Models tonixpharma.com ↗ |
| 2023-06-07 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Announces Data Presentations Involving TNX-1500 (anti-CD40L mAb) for the Prevention of Rejection in Kidney and Heart Allograft Transplantation in Animal Models at the 2023 American Transplant Congress tonixpharma.com ↗
The oral presentations titled, “ Fc-Modified anti-CD154 Mab Induced Long Term Renal Allograft Survival without Thromboembolic Complications ” by Dr. Ryo Otsuka et al. and “ Efficacy of CD154 Blockade with TNX-1500 to prevent heart allograft immune injury ” by Dr. Ikechukwu Ileka et al ., and the poster presentation titled “ anti-CD154 mAb (TNX-1500) Alone, or in Combination with Rapamycin, MMF, or anti-CD28 mAb (VEL-101) Prolongs Cynomolgus Cardiac Allograft Survival ” by Dr. Kohei Kinoshita et al. include data demonstrating that TNX-1500 showed activity in preventing organ rejection and was well tolerated in non-human primates. |
| 2023-05-04 | Tonix Pharmaceuticals, Inc. | Regulatory Tonix Pharmaceuticals Announces IND Clearance for TNX-1500 (anti-CD40L mAb) for the Prevention of Organ Rejection in Patients Receiving a Kidney Transplant tonixpharma.com ↗
CHATHAM, N.J., May 04, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to support a Phase 1 clinical trial with TNX-1500 (anti-CD40L monoclonal antibody [mAb]). |
| 2023-04-17 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Announces Two Publications of Data in American Journal of Transplantation Showing TNX-1500 (anti-CD40L mAb) Prolongs Nonhuman Primate Renal and Heart Allograft Survival tonixpharma.com ↗
The publications include data demonstrating that TNX-1500 showed activity in preventing organ rejection and was well tolerated in non-human primates. |
| 2022-09-15 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Announces Data Presentations Involving TNX-1500 (Fc-Modified Anti-CD40L mAb) for the Prevention of Rejection in Allograft and Xenograft Transplantation in Animal Models at the International Congress of The Transplantation Society (TTS 2022) tonixpharma.com ↗
Blockade of CD40L with TNX-1500 monotherapy consistently and safely prevented pathologic alloimmunity in non-human primate cardiac and kidney allograft models without clinical thrombosis. |
| 2022-06-09 | Tonix Pharmaceuticals, Inc. | Results Tonix Pharmaceuticals Announces Data Presentations Involving TNX-1500 (Fc-modified anti-CD40L mAb) for the Prevention of Rejection in Kidney and Heart Allograft Transplantation in Animal Models at the 2022 American Transplant Congress tonixpharma.com ↗
The presentations titled, “ Long-Term Rejection Free Renal Allograft Survival with Fc-Modified Anti-CD154 Antibody Monotherapy in Nonhuman Primates ,” “ TNX-1500, an Fc-modified Anti-CD154 Antibody, Prolongs Nonhuman Primate Cardiac Allograft Survival ,” and “ Novel Targetable Pathways in Costimulation Pathway Blockade ” include data demonstrating that TNX-1500 showed activity in preventing organ rejection and was well tolerated in non-human primates. |
All press releases naming this drug 27 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TNX-1500 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07473752 ↗ |
| Action | Inhibit | “anti-CD154” NCT07473752 ↗ |
| Modality | Monoclonal antibody | “TNX-1500, an FC-modified anti-CD154 mAb” NCT07204080 ↗ |