Drugs / Thymosin Beta 4
Thymosin Beta 4
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial · 1 met primary | ||||||
| Phase 2 | NCT01393132 | Mar 2011 → Dec 2012 | Sjogren syndrome, dry eye syndrome, graft versus host disease | Michigan Cornea Consultants, PC | Completed | Met primary |
| Comparator or background therapy7 trials | ||||||
| Phase 1 | NCT00743769 Comparator | Apr 2008 → Jan 2017 | myocardial infarction, myocardial ischemia | RegeneRx Biopharmaceuticals, Inc. | Withdrawn | No outcome recorded |
| Phase 2 | NCT01311518 Comparator | Jul 2019 → Jul 2020 | ST-elevation myocardial infarction | RegeneRx Biopharmaceuticals, Inc. | Withdrawn | No outcome recorded |
| Phase 2 | NCT01387347 Comparator | Aug → Oct 2011 | dry eye syndrome | ReGenTree, LLC | Completed | No outcome recorded |
| Phase 2 | NCT00598871 Comparator | Dec 2007 → Feb 2009 | diabetes mellitus | ReGenTree, LLC | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00832091 Comparator | Jul 2006 → Jan 2009 | ulcer of lower limbs | RegeneRx Biopharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00382174 Comparator | May 2006 → Dec 2008 | decubitus ulcer | RegeneRx Biopharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00311766 Comparator | Feb 2006 → Jul 2010 | epidermolysis bullosa | RegeneRx Biopharmaceuticals, Inc. | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 53
| Date | Issuer | Release |
|---|---|---|
| 2023-01-03 | RegeneRx Biopharmaceuticals, Inc. | Results Publication of RGN-259 Phase 3 Clinical Trial Results in Patients with Neurotrophic Keratopathy regenerx.com ↗
The study determined the efficacy and safety of RGN-259 in promoting the healing of persistent epithelial defects in patients with Stage 2 and Stage 3 NK. |
| 2022-10-24 | RegeneRx Biopharmaceuticals, Inc. | Regulatory RegeneRx Licensee Submits Special Protocol Assessment to FDA for 4th Phase 3 Clinical Trial for Dry Eye Disease regenerx.com ↗ |
| 2022-09-27 | RegeneRx Biopharmaceuticals, Inc. | Regulatory RegeneRx Partner Submits Phase 3 Protocol for Neurotrophic Keratopathy (NK) regenerx.com ↗ |
| 2022-01-25 | RegeneRx Biopharmaceuticals, Inc. | Results Researchers Confirm Thymosin Beta 4's Ability to Protect Eyes From Ethanol Injury regenerx.com ↗
RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("RegeneRx"), a clinical-stage drug development company focused on tissue protection, repair, and regeneration), today announced that Chinese researchers confirmed the ability of Thymosin beta 4 (Tβ4) to protect corneal stromal cells from damage due to ethanol exposure and significantly promote wound healing. |
| 2021-12-17 | RegeneRx Biopharmaceuticals, Inc. | Regulatory RegeneRx Joint Venture Will Hold Pre-BLA Meeting with FDA on February 28, 2022 regenerx.com ↗ |
| 2021-10-29 | RegeneRx Biopharmaceuticals, Inc. | Results Clinical Results of RGN-259 for the Treatment of Neurotrophic Keratitis to be Presented at 2021 American Ophthalmology Association Meeting regenerx.com ↗
Six out of 10 patients in the RGN-259-treated group and 1 out of 8 patients in the placebo-treated group achieved complete corneal healing in 4 weeks. |
| 2021-10-05 | RegeneRx Biopharmaceuticals, Inc. | Results New Research Demonstrates Thymosin Beta 4's Potential Positive Effects on Alzheimer's Disease regenerx.com ↗
According to the researchers, among other findings, Tβ4 over-expression in the mouse models alone showed less amyloid beta peptide, or amyloid deposits, which correlates with the clinical status of the patient. |
| 2021-05-14 | RegeneRx Biopharmaceuticals, Inc. | Results RegeneRx Joint Venture Reports Positive Results from ARISE-3 Clinical Trial Using RGN-259 to Treat Dry Eye Syndrome regenerx.com ↗
RGN-259 also confirmed its consistent safety and tolerance profile. |
| 2021-03-18 | RegeneRx Biopharmaceuticals, Inc. | Results RegeneRx Reports Topline Results of ARISE-3 Dry Eye Trial regenerx.com ↗ |
| 2020-09-08 | RegeneRx Biopharmaceuticals, Inc. | Results New Research Paper Suggests RegeneRx's Thymosin Beta 4 May be Useful in Treating COVID-19 regenerx.com ↗
According to the scientific team, an increase of fibrinolysis could be achieved by increasing ACE, or by administering Tβ4. |
| 2020-05-27 | RegeneRx Biopharmaceuticals, Inc. | Regulatory RegeneRx Advisory on Reclassification of Thymosin Beta 4 from Drug to Biologic regenerx.com ↗ |
| 2020-05-14 | RegeneRx Biopharmaceuticals, Inc. | Results RegeneRx Joint Venture Announces Efficacy Results of Neurotrophic Keratopathy Phase 3 Clinical Trial with RGN-259 regenerx.com ↗
Six out of 10 patients in the RGN-259 treated group and 1 out of 8 patients in the placebo treated group achieved complete corneal healing in 4 weeks. |
| 2020-04-02 | RegeneRx Biopharmaceuticals, Inc. | Results New Publication Describes Mechanism of Action for Tβ4 in Corneal Wound Healing and Regeneration regenerx.com ↗
The results of this study suggest that Tβ4-mediated HCEC proliferation and migration are associated with increased ATP levels, P2X7 R-mediated Ca2+ influx, and the ERK1/2 signaling pathway, which describes one of the mechanisms of action for Tβ4-mediated corneal healing and regeneration. |
| 2019-11-18 | RegeneRx Biopharmaceuticals, Inc. | Results RegeneRx's Tβ4 Significantly Reduces Damage in Ischemic Acute Kidney Injury Model regenerx.com ↗
In this study, researchers reported that administration of Tβ4 to animals with induced kidney injury significantly reduced ischemic acute kidney injury. |
| 2019-11-14 | RegeneRx Biopharmaceuticals, Inc. | Results RegeneRx's Tβ4 Promotes Autophagy and Repair in Chronic Granulomatous Disease Model regenerx.com ↗ |
| 2018-09-06 | RegeneRx Biopharmaceuticals, Inc. | Regulatory World Health Organization Recommends INN for Thymosin Beta 4 as "timbetasin" regenerx.com ↗
RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("the Company" or "RegeneRx"), a clinical-stage drug development company focused on tissue protection, repair and regeneration, today announced that the recommended INN (International Nonproprietary Name) for Thymosin Beta 4 is timbetasin, as published by the World Health Organization (WHO). |
| 2018-07-16 | RegeneRx Biopharmaceuticals, Inc. | Results RGN-259 (Tβ4) Improves Clinically Important Dry Eye Efficacies in Comparison with Prescription Drugs in Dry Eye Model regenerx.com ↗
In the study, researchers demonstrated that after ten days of treatment RGN-259 performed equal to or better than cyclosporine A (Restasis®), lifitegrast (Xiidra®), and diquafosol (Diquas®). |
| 2018-05-02 | RegeneRx Biopharmaceuticals, Inc. | Results ReGenTree Presents Results of a Comparison Study of RGN-259 and Approved Prescription Drugs for Dry Eye Syndrome in a Mouse Model at ARVO regenerx.com ↗
The study found that RGN-259 treatment promoted recovery of mucins and goblet cells, improved corneal integrity, increased tears, and reduced inflammation in a dry eye mouse model. |
| 2018-04-25 | RegeneRx Biopharmaceuticals, Inc. | Results GtreeBNT Discloses Preliminary Observations from Seventeen NK Patients Treated with RGN-259 Eye Drops regenerx.com ↗
GtreeBNT, its joint venture partner for development of RGN-259 in the U.S., has disclosed that 7 of 17 patients enrolled in an orphan Phase 3 clinical trial for neurotrophic keratopathy (NK) have completely healed. |
| 2018-04-09 | RegeneRx Biopharmaceuticals, Inc. | Regulatory RegeneRx Announces Outcome of FDA Discussions for Development of RGN-259 for Dry Eye Syndrome regenerx.com ↗
ReGenTree is now planning to initiate the ARISE-3 trial this year, |
| 2018-03-12 | RegeneRx Biopharmaceuticals, Inc. | Regulatory RegeneRx Receives "Decision to Grant" European Patent For Treatment of Peripheral Neuropathy regenerx.com ↗ |
| 2017-11-16 | RegeneRx Biopharmaceuticals, Inc. | Results Tβ4's Role in Treatment of Eye Diseases Showcased at 5th International Thymosin Symposium regenerx.com ↗
In his talk, Dr. Sosne presented data demonstrating Tβ4's important role in corneal wound healing at the benchtop and in his clinical experiences. |
| 2017-10-31 | RegeneRx Biopharmaceuticals, Inc. | Results RegeneRx JV Announces Results of ARISE-2 Dry Eye Trial regenerx.com ↗
The ARISE-2 study, which was conducted together with Ora, Inc., demonstrated a number of statistically significant improvements in both signs and symptoms of dry eye syndrome with 0.1% RGN-259 versus placebo, while showing excellent safety, comfort, and tolerability profiles. |
| 2017-09-13 | RegeneRx Biopharmaceuticals, Inc. | Regulatory RegeneRx Receives Notice of Allowance for Key Dry Eye Patent in U.S. regenerx.com ↗ |
| 2017-05-09 | RegeneRx Biopharmaceuticals, Inc. | Results RegeneRx JV Presents Results of Phase 2b/3 (ARISE-1) Dry Eye Trial at ARVO 2017 regenerx.com ↗
As previously reported, the double-masked, placebo-controlled trial in 317 patients with dry eye syndrome demonstrated that after 28 days of treatment, RGN-259 was safe and significantly reduced ocular discomfort both during and after exposure to a controlled adverse environment (CAE®). |
| 2016-11-02 | RegeneRx Biopharmaceuticals, Inc. | Regulatory RegeneRx Receives Notice of Allowance for Patent for Tβ4 Eye Drop Formulation regenerx.com ↗ |
| 2016-08-29 | RegeneRx Biopharmaceuticals, Inc. | Regulatory RegeneRx Receives Notice of Intent to Grant Patent for the Treatment of Patients with Multiple Sclerosis in EU regenerx.com ↗
RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("the Company" or "RegeneRx"), a clinical-stage drug development company focused on tissue protection, repair and regeneration, today announced that it has received notice of Intent to Grant a patent from the European Patent Office for the treatment of patients with MS. |
| 2016-08-24 | RegeneRx Biopharmaceuticals, Inc. | Regulatory RegeneRx Joint Venture to Begin Second Phase 3 Study Of RGN-259 for Dry Eye Syndrome in 3rd Quarter regenerx.com ↗
ROCKVILLE, Md., Aug. 24, 2016 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("the Company" or "RegeneRx"), a clinical-stage drug development company focused on tissue protection, repair and regeneration, today announced that its U.S. joint venture, ReGenTree, LLC, has received permission from the U.S. FDA to proceed with a second Phase 3 clinical trial using RGN-259 to treat patients with dry eye syndrome (DES). |
| 2016-08-03 | RegeneRx Biopharmaceuticals, Inc. | Regulatory RegeneRx Receives Notice of Allowance for Key U.S. Patent That Expands and Extends Exclusivity of Company's Product Candidates regenerx.com ↗ |
| 2016-06-14 | RegeneRx Biopharmaceuticals, Inc. | Results Thymosin Beta 4 Effective in Treatment of Heart Attack Patients regenerx.com ↗
today announced a publication of a pilot clinical trial demonstrating that Thymosin beta 4 (Tβ4) was effective in the treatment of patients after an acute ST segment elevation myocardial infarction (STEMI), or heart attack |
| 2016-05-17 | RegeneRx Biopharmaceuticals, Inc. | Results RegeneRx Releases Letter to Stockholders regenerx.com ↗
Overall the results were very positive and accomplished much of what we and our partner, GtreeBNT, set out to accomplish. |
| 2016-05-06 | RegeneRx Biopharmaceuticals, Inc. | Results RGN-259 Confirms Efficacy in Signs and Symptoms of Dry Eye regenerx.com ↗
The 317-patient Phase 2/3 trial (ClinicalTrials.gov Identifier: NCT02597803) demonstrated statistically significant improvements in both signs and symptoms of dry eye with 0.05% and 0.1% RGN-259 compared to placebo in a dose dependent manner during a 28-day dosing period. |
| 2016-04-06 | RegeneRx Biopharmaceuticals, Inc. | Regulatory RegeneRx to Receive EU Patent for Use of Tb4 in Preventing And Treating Damage Associated with Reperfusion Injury regenerx.com ↗ |
| 2016-01-27 | RegeneRx Biopharmaceuticals, Inc. | Results RegeneRx's TB4 Shown to Promote Regeneration and Repair of Damaged Central Nervous System Cells regenerx.com ↗ |
| 2015-12-23 | RegeneRx Biopharmaceuticals, Inc. | Results RegeneRx Joint Venture Posts Results of Severe Dry Eye Trial On ClinicalTrials.gov regenerx.com ↗
The data demonstrated statistically significant improvements of corneal damage and ocular discomfort (signs and symptoms) in patients with severe dry eye, meeting the trial's key efficacy objectives. |
| 2015-12-04 | RegeneRx Biopharmaceuticals, Inc. | Regulatory RegeneRx Receives Chinese Patent for Key TB4 Peptide Fragment regenerx.com ↗ |
| 2015-10-23 | RegeneRx Biopharmaceuticals, Inc. | Regulatory RegeneRx Updates on Asian Ophthalmic Clinical Trials regenerx.com ↗
G-treeBNT, RegeneRx's licensee in Korea, Australia, Japan and a number of other countries in Asia, recently received permission from the Korean Ministry of Food and Drug Safety (MFDS) to begin its Phase 2b/3 clinical trial for dry eye syndrome in Korea. |
| 2015-10-20 | RegeneRx Biopharmaceuticals, Inc. | Results RegeneRx's TB4 Shown to Significantly Limit Brain Damage After Stroke by Upregulating microRNA-200a regenerx.com ↗
The authors found that miR-200a, a very short and specific piece of RNA, is increased in the presence of TB4 in an in vitro stroke model, as well as when TB4 is administered systemically in a similar model. |
| 2015-08-12 | RegeneRx Biopharmaceuticals, Inc. | Results New Publication Elaborates on TB4's Effects on Dry Eye Syndrome and Other Potential Ophthalmic Disorders regenerx.com ↗ |
| 2015-08-06 | RegeneRx Biopharmaceuticals, Inc. | Regulatory RegeneRx Provides Update on Clinical Trials in U.S., Korea and China regenerx.com ↗
G-treeBNT recently received permission from the Korean Ministry of Food and Drug Safety (MFDS) to begin its Phase IIb/III clinical trial for dry eye syndrome in Korea. |
| 2015-07-22 | RegeneRx Biopharmaceuticals, Inc. | Regulatory RegeneRx Receives Notice of Acceptance for Australian Patent for Key TB4 Peptide Fragment regenerx.com ↗ |
| 2015-07-17 | RegeneRx Biopharmaceuticals, Inc. | Regulatory RegeneRx Korean Licensee Receives Government Approval to Conduct Phase 2b/3 Clinical Trial in Patients with Dry Eye Syndrome regenerx.com ↗ |
| 2015-07-14 | RegeneRx Biopharmaceuticals, Inc. | Regulatory U.S. PTO Issues Notice of Allowance for Patent using TB4 for Improving Neurological Outcomes After Injury and Neurodegenerative Disease regenerx.com ↗ |
| 2015-06-02 | RegeneRx Biopharmaceuticals, Inc. | Results Clinical Trial Demonstrates Elevated Thymosin Beta 4 Plasma Levels are Associated with Improvement of Symptoms After Stem Cell Therapy in Patients with Ischemic Heart Failure regenerx.com ↗
There was a significant increase in circulating levels of TB4 [in the stem cell-injected responder group only] 24 hours after intracardiac injection, which was directly associated with improvement in cardiac symptoms 6 months post-treatment. |
| 2015-05-22 | RegeneRx Biopharmaceuticals, Inc. | Results Complete Data from RegeneRx Phase II Dry Eye Trial Published in Current Issue of Clinical Ophthalmology regenerx.com ↗ |
| 2015-05-08 | RegeneRx Biopharmaceuticals, Inc. | Results Researchers Report that Long-Term Administration of Thymosin B4 in a Diabetic Animal Model Prevents Progression of Peripheral Neuropathy and Restores Sciatic Nerve Function regenerx.com ↗
The improvement is closely associated with amelioration of sciatic nerve axonal and myelin damage and an increase of intraepidermal nerve fiber density. |
| 2015-05-04 | RegeneRx Biopharmaceuticals, Inc. | Results Researchers Report that Thymosin B4 has a Major Role in Dermal Burn Wound Healing regenerx.com ↗
These results show an additional new potential application for TB4 and provide a greater understanding of its effects in dermal wound healing and specifically in the healing of dermal burns. |
| 2015-04-01 | RegeneRx Biopharmaceuticals, Inc. | Results RegeneRx's RGN-259 Meets Key Efficacy Objectives in Phase 2 Clinical Trial in Patients with Severe Dry Eye Reported in Current Issue of Cornea regenerx.com ↗
The results met key efficacy objectives of the study and the physicians stated that statistically significant differences in both signs and symptoms of severe dry eye were seen at various time points throughout the study. |
| 2015-04-01 | RegeneRx Biopharmaceuticals, Inc. | Results RegeneRx's RGN-259 Meets Key Efficacy Objectives in Phase 2 Clinical Trial in Patients with Severe Dry Eye Reported in Current Issue of Cornea regenerx.com ↗
The results met key efficacy objectives of the study and the physicians stated that statistically significant differences in both signs and symptoms of severe dry eye were seen at various time points throughout the study. |
| 2015-03-03 | RegeneRx Biopharmaceuticals, Inc. | Results Researchers at Henry Ford Hospital Propose Thymosin Beta 4 as Novel Way to Treat Neural Injury and Neurodegenerative Diseases regenerx.com ↗
They pointed out that oligodendrogenesis and myelination are two of several common links in their studies by which TB4 promotes "self-recovery" and suggest that treatment strategies should be focused on pharmacologically enhancing the brain's own restorative abilities. |
| 2015-02-25 | RegeneRx Biopharmaceuticals, Inc. | Regulatory RegeneRx Receives Israeli Patent for Treating and Repairing Heart Damage regenerx.com ↗ |
| 2014-12-29 | RegeneRx Biopharmaceuticals, Inc. | Regulatory RegeneRx Partner Submits Phase IIB/III IND to Korean Health Authority for RGN-259 for the Treatment of Dry Eye Syndrome regenerx.com ↗ |
| 2014-10-20 | RegeneRx Biopharmaceuticals, Inc. | Regulatory RegeneRx Allowed to Proceed with Phase 3 Using RGN-259 Eye Drops for the Treatment of Neurotrophic Keratopathy regenerx.com ↗ |
All press releases naming this drug 71 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Thymosin Beta 4 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00832091 ↗ |
| Known as | RGN-259 | “The purpose of this study was to evaluate the safety and efficacy of Thymosin β4 eye drops (RGN-259) as a novel therapy for severe dry eye disease (including that associated...” PMID 25826322 ↗ May 2015 |
| Known as | RGN-259 (eye drop formulation of Tβ4) | “RGN-259 (eye drop formulation of Tβ4)” NCT01387347 ↗ |
| Known as | Thymosin β4 | “The purpose of this study was to evaluate the safety and efficacy of Thymosin β4 eye drops (RGN-259) as a novel therapy for severe dry eye disease (including that associated...” PMID 25826322 ↗ May 2015 |
| Known as | Tβ4 | “Tβ4 is a synthetically-produced copy of a naturally-occurring 43 amino acid peptide that has wound healing and anti-inflammatory properties and can up-regulate the expression...” NCT00311766 ↗3“RGN-352 (thymosin beta 4, Tβ4, Injectable Solution)” NCT01311518 ↗ “Thymosin Beta 4 (Tβ4), administered topically” NCT00382174 ↗ “Thymosin Beta 4 (Tβ4)” NCT00598871 ↗ |
| Action | Activate | “It up-regulates the gene expression of laminin-5” NCT01387347 ↗ |
| Modality | Peptide | “Tβ4 is a synthetically-produced copy of a naturally-occurring 43 amino acid peptide” NCT00311766 ↗ |
| Route | Topical | “Topical administration” NCT00311766 ↗ |