{"format":"citation-manifest/v1","page":"https://tb500co.com/monograph","claim_count":66,"claims":[{"id":"TB-001","text":"TB-500 is the N-terminally acetylated 17-23 fragment of thymosin beta-4, sequence Ac-LKKTETQ, molecular formula C38H68N10O14, molecular weight 889.0 Da, CAS 885340-08-9.","source_url":"https://pubchem.ncbi.nlm.nih.gov/compound/62707662","grade":"chemical-reference","grade_label":"Chemical reference"},{"id":"TB-002","text":"Thymosin beta-4, the parent protein, is 43 amino acids with molecular formula C212H350N56O78S and molecular weight 4963, roughly 5.6 times the mass of the TB-500 fragment.","source_url":"https://pubchem.ncbi.nlm.nih.gov/compound/45382195","grade":"chemical-reference","grade_label":"Chemical reference"},{"id":"TB-003","text":"Mass-spectrometric analysis of a TB-500 product identified its constituent as the N-terminal acetylated 17-23 fragment of human thymosin beta 4 (Ac-LKKTETQ); the peptide was independently synthesised as a reference standard.","source_url":"https://europepmc.org/article/MED/22962027","grade":"analytical","grade_label":"Analytical study"},{"id":"TB-004","text":"The LKKTETQ sequence at residues 17-23 is the actin-binding site of thymosin beta-4, which is why it was isolated and sold as a separate product.","source_url":"https://europepmc.org/article/MED/20179146","grade":"review","grade_label":"Review or guideline"},{"id":"TB-010","text":"TB-500 is not FDA approved; a Drugs@FDA search returns no approved product containing thymosin beta-4 or TB-500 in any form.","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm","grade":"regulatory","grade_label":"Regulatory record"},{"id":"TB-011","text":"FDA's compounding safety-risks page lists 'Thymosin beta-4, fragment (LKKTETQ), also known as TB-500' and states that FDA has not identified any human exposure data for drug products containing the fragment.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","grade":"regulatory","grade_label":"Regulatory record"},{"id":"TB-012","text":"FDA states that compounded drugs containing the thymosin beta-4 fragment may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation as well as peptide-related impurities, and that it lacks important information about any safety issues including whether the drug would cause harm if administered to humans.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","grade":"regulatory","grade_label":"Regulatory record"},{"id":"TB-013","text":"On July 23, 2026, FDA's Pharmacy Compounding Advisory Committee considered TB-500-related bulk drug substances (TB-500 free base and TB-500 acetate) for inclusion on the 503A Bulks List; the nomination came from Wells Pharmacy Network and had been withdrawn by the nominator, but FDA elected to proceed.","source_url":"https://www.fda.gov/media/193342/download","grade":"regulatory","grade_label":"Regulatory record"},{"id":"TB-014","text":"FDA's July 2026 PCAC briefing document proposed that TB-500 (free base) NOT be included and that TB-500 acetate NOT be included on the 503A Bulks List.","source_url":"https://www.fda.gov/media/193342/download","grade":"regulatory","grade_label":"Regulatory record"},{"id":"TB-015","text":"PCAC advice is non-binding and rulemaking is pending; inclusion on the 503A Bulks List would permit pharmacy compounding, not constitute FDA approval.","source_url":"https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026","grade":"regulatory","grade_label":"Regulatory record"},{"id":"TB-016","text":"The 2026 WADA Prohibited List names 'Thymosin-beta4 and its derivatives e.g. TB-500' under section S2.3 (growth factors and growth factor modulators); S2 is prohibited at all times, in and out of competition.","source_url":"https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf","grade":"regulatory","grade_label":"Regulatory record"},{"id":"TB-017","text":"The 2026 WADA Prohibited List states that all prohibited substances in the S2 class are non-Specified Substances, in contrast to S0 where all prohibited substances are Specified Substances.","source_url":"https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf","grade":"regulatory","grade_label":"Regulatory record"},{"id":"TB-020","text":"A review of thymosin beta-4 active sites reports that a short sequence containing LKKTETQ promotes angiogenesis, wound repair and cell migration, while the amino-terminal Ac-SDKP site blocks inflammation and reduces fibrosis.","source_url":"https://europepmc.org/article/MED/20179146","grade":"review","grade_label":"Review or guideline"},{"id":"TB-021","text":"In human hepatic stellate cells, the 17-23 (LKKTETQ) peptide but not the 1-15 peptide blocked PDGF-BB-dependent upregulation of the PDGF-beta receptor, alpha-SMA and collagen 1, blunted Akt phosphorylation, and inhibited proliferation and migration; the authors conclude the anti-fibrogenic actions of thymosin beta-4 are exerted via 17-23.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC6748868/","grade":"in-vitro","grade_label":"In vitro"},{"id":"TB-022","text":"Thymosin beta-4 (the full protein) forms a functional complex with PINCH and integrin-linked kinase, activates Akt, and after coronary artery ligation in mice increased ILK and Akt activity, enhanced early myocyte survival and improved cardiac function.","source_url":"https://europepmc.org/article/MED/15565145","grade":"animal","grade_label":"Animal"},{"id":"TB-023","text":"A 2024 analytical and metabolic study of TB-500 states directly that the biological effects of TB-500 have not been documented.","source_url":"https://europepmc.org/article/MED/38382158","grade":"animal-pk","grade_label":"Animal PK"},{"id":"TB-024","text":"In rats given TB-500, only the metabolite Ac-LKKTE showed significant wound-repair activity versus control, and the authors state that the previously reported wound-repair activity of TB-500 in the literature may be due to its metabolite Ac-LKKTE rather than the parent form.","source_url":"https://europepmc.org/article/MED/38382158","grade":"animal-pk","grade_label":"Animal PK"},{"id":"TB-030","text":"FDA's compounding safety-risks page carries the TB-500 entry alongside separate entries for other peptides including thymosin-alpha 1, MOTS-c, selank acetate and semax; the thymosin beta-4 fragment entry is the one that applies to TB-500.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","grade":"regulatory","grade_label":"Regulatory record"},{"id":"TB-040","text":"No human study of the LKKTETQ fragment has been published for any indication; the only human record is a registry entry with no results posted.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","grade":"absence-of-evidence","grade_label":"Absence of evidence"},{"id":"TB-041","text":"NCT07487363 is a phase 1/2 randomized, double-blind, placebo-controlled sequential dose-escalation study of TB-500 (thymosin beta 4 17-23 fragment) in adults with stable atherosclerotic cardiovascular disease, target enrolment 80, three dose cohorts randomised 3:1 against placebo, primary endpoints incidence of treatment-emergent adverse events and incidence of serious adverse events, sponsored by Hudson Biotech, first posted 2026-03-14, recruiting in Shenzhen, no results posted.","source_url":"https://clinicaltrials.gov/study/NCT07487363","grade":"registry","grade_label":"Registry record"},{"id":"TB-042","text":"Fifteen completed or terminated registered clinical trials of thymosin beta-4, the full 43-amino-acid protein, enrolled 2,143 participants in total (actual enrolment counts).","source_url":"https://clinicaltrials.gov/study/NCT02597803","grade":"internal-measurement","grade_label":"Internal measurement"},{"id":"TB-050","text":"This site's graded evidence table contains 26 primary research and registry entries: 14 human rows and 12 nonhuman or laboratory rows, comprising 11 fragment rows, 13 full-protein rows, 1 row testing both molecules side by side and 1 row where the source does not identify the molecule.","source_url":"https://tb500co.com/monograph","grade":"internal-measurement","grade_label":"Internal measurement"},{"id":"TB-051","text":"Of the 11 fragment rows in this site's evidence table, 10 are animal, in vitro or analytical and the single human row is a registry record with no results; of the 13 full-protein rows, 12 are human.","source_url":"https://tb500co.com/monograph","grade":"internal-measurement","grade_label":"Internal measurement"},{"id":"TB-052","text":"A 2026 scoping review of six emerging peptides including TB-500 found that 67% of identified publications used preclinical animal models, that human clinical studies were limited to a handful of investigations mostly lacking robust controls, and concluded the claimed benefits remain unsubstantiated by current human trials.","source_url":"https://europepmc.org/article/MED/42578445","grade":"systematic-review","grade_label":"Systematic review"},{"id":"TB-053","text":"Independent 2026 reviews state that unapproved peptides show favourable outcomes in animal models while rigorous human safety data are scarce, that TB-4 and its derivative TB-500 promoted angiogenesis and tissue repair in preclinical models but human orthopaedic data are lacking and both remain banned in sport, and that there is a current lack of clinical trials.","source_url":"https://europepmc.org/article/MED/41966639","grade":"review","grade_label":"Review or guideline"},{"id":"TB-060","text":"In a 2026 study, 32 rats underwent Achilles tendon transection and repair and were randomised to control, BPC-157 10 ug/kg/day, TB-500 60 ug/kg/day, or both, intraperitoneally for four weeks; maximum load to failure was higher in both peptide groups than controls, reaching statistical significance in the TB-500 group (p<0.05); total Bonar scores were significantly lower with TB-500 (p=0.016) and total Movin scores with TB-500 and the combination (p=0.017 and p=0.040); BPC-157 was numerically lower without reaching significance on total scores; the combination conferred no additional benefit.","source_url":"https://europepmc.org/article/MED/42542926","grade":"animal","grade_label":"Animal"},{"id":"TB-061","text":"Thymosin beta-4 accelerated repair of full-thickness dermal wounds in db/db diabetic mice and in 26-month-old aged mice, and the actin-binding domain reproduced as the seven-amino-acid synthetic peptide LKKTETQ promoted repair in the aged animals comparable to the parent molecule.","source_url":"https://europepmc.org/article/MED/12581423","grade":"animal","grade_label":"Animal"},{"id":"TB-062","text":"The LKKTETQ peptide, the common actin-binding domain of thymosin beta-4 and beta-10, significantly enhanced skin wound repair in vitro and in vivo, with the effect suggested to be mediated by purinergic receptors.","source_url":"https://europepmc.org/article/MED/17001601","grade":"animal-and-in-vitro","grade_label":"Animal and in vitro"},{"id":"TB-063","text":"A TB500 peptide hydrogel promoted human corneal epithelial cell migration, proliferation and tight junction recovery in vitro and accelerated epithelial regeneration in an alkali burn model; the authors describe it as the first ocular application of TB500, and the abstract does not state the animal species.","source_url":"https://europepmc.org/article/MED/41359360","grade":"animal-and-in-vitro","grade_label":"Animal and in vitro"},{"id":"TB-064","text":"TB500 and Ac-SDKP attenuated neurite atrophy and inflammatory markers in cell models and improved Morris water maze and novel object recognition performance in 5xFAD mice, while hippocampal amyloid burden remained unchanged.","source_url":"https://europepmc.org/article/MED/41443105","grade":"animal-and-in-vitro","grade_label":"Animal and in vitro"},{"id":"TB-070","text":"No regulator has approved thymosin beta-4 in any form; a 2025 ophthalmology paper describes RGN-259 as having led to clinical trials with full FDA approval still pending.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC12636994/","grade":"regulatory","grade_label":"Regulatory record"},{"id":"TB-071","text":"In the posted results of the ARISE-2 phase 3 dry eye trial (n=601), mean change from baseline at day 29 was 0.07 for RGN-259 versus -0.04 for placebo on the ocular discomfort scale, and 0.07 versus -0.01 on corneal fluorescein staining; neither co-primary endpoint favoured the drug.","source_url":"https://clinicaltrials.gov/study/NCT02974907","grade":"human-rct","grade_label":"Human RCT"},{"id":"TB-072","text":"In a 72-subject phase 2 dry eye trial using the controlled adverse environment model, neither primary endpoint differed significantly between 0.1% thymosin beta-4 and placebo; several secondary endpoints did, with discomfort in the challenge reduced 27% (P=0.0244) and central and superior corneal staining improved (P=0.0075 and P=0.0210); no adverse events were observed.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC4445951/","grade":"human-rct","grade_label":"Human RCT"},{"id":"TB-073","text":"In a 9-patient phase 2 trial in severe dry eye, RGN-259 0.1% produced a 35.1% reduction in ocular discomfort (P=0.0141) and a 59.1% reduction in total corneal fluorescein staining (P=0.0108) versus vehicle at day 56, and was safe and well tolerated.","source_url":"https://europepmc.org/article/MED/25826322","grade":"human-rct","grade_label":"Human RCT"},{"id":"TB-074","text":"Intravenous thymosin beta-4 (the full protein) has been given to humans: a published phase 1 study dosed four cohorts of 10 healthy subjects at 42, 140, 420 or 1260 mg, single dose then daily for 14 days, with infrequent mild-to-moderate adverse events, no dose-limiting toxicity, dose-proportional single-dose pharmacokinetics and half-life increasing with dose. Recombinant human thymosin beta-4 has since completed phase 1a (54 subjects, 0.5 to 25 ug/kg IV), phase 1b (30 subjects, 0.5 to 5.0 ug/kg for 10 days) and phase 2a and 2b myocardial infarction trials (62 and 90 participants), none with results posted.","source_url":"https://europepmc.org/article/MED/20536472","grade":"human-pk","grade_label":"Human PK"},{"id":"TB-075","text":"The phase 3 SEER-1 trial of RGN-259 in neurotrophic keratopathy was terminated after 18 participants for a business decision, and the 2025 Cochrane review found that 0.1% RGN-259 may not increase the proportion of participants with corneal re-epithelialization (RR 9.00, 95% CI 0.57 to 141.88; 18 participants; low-certainty evidence).","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC12679690/","grade":"systematic-review","grade_label":"Systematic review"},{"id":"TB-076","text":"Phase 2 trials of topical thymosin beta-4 gel ran in venous stasis ulcers and pressure ulcers with 72 participants each; the venous ulcer study randomised 73 patients across eight European sites, reported a safety profile comparable to placebo, suggested that a 0.03% dose may have potential to speed wound closure with complete closure within three months in about 25% of patients, and a later investigator review summarised both trials as shortening time to closure by almost a month in patients whose ulcers closed.","source_url":"https://europepmc.org/article/MED/20536470","grade":"human-rct","grade_label":"Human RCT"},{"id":"TB-077","text":"Both epidermolysis bullosa trials of topical thymosin beta-4 were terminated early: one after 30 participants for lack of patient availability and expiration of study drug, the other (RGN-137 CELEB) after 4 participants for a business decision.","source_url":"https://clinicaltrials.gov/study/NCT00311766","grade":"registry","grade_label":"Registry record"},{"id":"TB-078","text":"The two registered systemic thymosin beta-4 programs in the United States were withdrawn without dosing anyone: the RGN-352 myocardial infarction trial with the note that the trial was never initiated, and a phase 1 intravenous study never initiated due to contract manufacturing issues.","source_url":"https://clinicaltrials.gov/study/NCT01311518","grade":"registry","grade_label":"Registry record"},{"id":"TB-080","text":"A racing laboratory describes TB-500 as a veterinary preparation containing a synthetic version of LKKTETQ, and confirmed the N-acetylated peptide and its metabolites in equine urine and plasma after a single dose of TB-500 containing 10 mg of N-acetylated LKKTETQ, at detection levels of 0.02 ng/mL in plasma and 0.01 ng/mL in urine; the authors describe this as the first identification of TB-500 and its metabolites in post-administration samples from horses.","source_url":"https://europepmc.org/article/MED/23084823","grade":"animal-pk","grade_label":"Animal PK"},{"id":"TB-081","text":"A companion method detected N-acetylated LKKTETQ and its metabolite N-acetylated LK in plasma from two thoroughbred geldings after subcutaneous administration of TB-500 containing 10 mg of the peptide, with limits of detection under 50 pg/mL for all seven peptides studied.","source_url":"https://europepmc.org/article/MED/23318763","grade":"animal-pk","grade_label":"Animal PK"},{"id":"TB-082","text":"A French racing laboratory reports that thymosin beta-4 use is forbidden by the IFHA, the FEI and WADA, that numerous products claiming to contain a synthetic acetylated fragment of the protein or the protein itself are available online, and established the first estimate of endogenous thymosin beta-4 concentration in racing horses.","source_url":"https://europepmc.org/article/MED/39314109","grade":"animal-pk","grade_label":"Animal PK"},{"id":"TB-083","text":"The detection of a non-natural synthesis impurity is possible in equine plasma after a single dose administration of a TB4-containing product.","source_url":"https://europepmc.org/article/MED/39314109","grade":"animal-pk","grade_label":"Animal PK"},{"id":"TB-090","text":"The only published human report involving a peptide identified as TB4 is a retrospective knee-pain chart review in which 4 of 16 patients reached received it in combination with BPC-157; of those 4, 75% reported significant improvement and 25% reported no relief, with no control group, no imaging and no standardised measurement instruments.","source_url":"https://europepmc.org/article/MED/34324435","grade":"human-obs","grade_label":"Human observational"},{"id":"TB-091","text":"That knee-pain report names the peptide only as thymosin-beta-4 (TB4) and does not state whether the injected material was the full 43-amino-acid protein or the LKKTETQ fragment, so it cannot be attributed to TB-500.","source_url":"https://europepmc.org/article/MED/34324435","grade":"human-obs","grade_label":"Human observational"},{"id":"TB-100","text":"No human pharmacokinetic study of TB-500 has been published; no half-life, bioavailability, clearance route or dose-exposure relationship has been measured for the fragment in a person.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","grade":"absence-of-evidence","grade_label":"Absence of evidence"},{"id":"TB-101","text":"In rats treated with TB-500, Ac-LK was the primary metabolite at highest concentration in the 0 to 6 hour interval and Ac-LKK was a long-term metabolite detected up to 72 hours.","source_url":"https://europepmc.org/article/MED/38382158","grade":"animal-pk","grade_label":"Animal PK"},{"id":"TB-102","text":"TB-500 and its metabolites are detectable in equine plasma and urine after subcutaneous administration at limits of roughly 0.01 to 0.02 ng/mL.","source_url":"https://europepmc.org/article/MED/23084823","grade":"animal-pk","grade_label":"Animal PK"},{"id":"TB-103","text":"TB-500 is one of four doping-relevant model peptides used in a published study of adsorption to glassware and plasticware, which found that the optimal consumable depends on the peptide's physicochemical properties rather than on cost.","source_url":"https://europepmc.org/article/MED/28887173","grade":"analytical","grade_label":"Analytical study"},{"id":"TB-104","text":"Published human pharmacokinetics exist for the full protein at intravenous doses of 42 to 1260 mg, showing dose-proportional exposure and half-life increasing with dose; those doses are between roughly 4 and 140 times the total content of a typical 2 to 10 mg gray-market TB-500 vial, of a molecule 5.6 times the mass.","source_url":"https://europepmc.org/article/MED/20536472","grade":"human-pk","grade_label":"Human PK"},{"id":"TB-110","text":"TB-500 is sold as lyophilised powder in vials commonly labelled 2, 5 or 10 mg, for reconstitution and injection; FDA's compounding entry addresses this product class and flags immunogenicity risk for certain routes of administration.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","grade":"regulatory","grade_label":"Regulatory record"},{"id":"TB-111","text":"No published study has administered TB-500 subcutaneously or intramuscularly to a human being; the full-protein human trials used eye drops, topical gel or intravenous infusion.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","grade":"absence-of-evidence","grade_label":"Absence of evidence"},{"id":"TB-120","text":"There is no established human dose of TB-500 and no published human dose-finding study; the one registered dose-escalation study does not disclose its dose levels publicly and has posted no results.","source_url":"https://clinicaltrials.gov/study/NCT07487363","grade":"absence-of-evidence","grade_label":"Absence of evidence"},{"id":"TB-121","text":"The published doses for TB-500 and for the full protein sit in four different unit systems across two molecules and four species, and no validated method exists for converting between them.","source_url":"https://europepmc.org/article/MED/42542926","grade":"absence-of-evidence","grade_label":"Absence of evidence"},{"id":"TB-130","text":"No human safety dataset exists for TB-500 and no animal toxicology program for the fragment has been published; the only reported safety-relevant finding is an absence of cytotoxicity for the parent peptide and its metabolites in the rat metabolism study's assays.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","grade":"absence-of-evidence","grade_label":"Absence of evidence"},{"id":"TB-131","text":"The aggregation behaviour of the TB-500 peptide in marketed vials has not been characterised in any published work located in this build, although aggregation is the specific mechanism FDA names in its immunogenicity concern.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","grade":"absence-of-evidence","grade_label":"Absence of evidence"},{"id":"TB-132","text":"The proposed mechanism of the fragment is pro-angiogenic and pro-migratory, and no study has examined people with a current or past cancer.","source_url":"https://europepmc.org/article/MED/20179146","grade":"absence-of-evidence","grade_label":"Absence of evidence"},{"id":"TB-140","text":"No side-effect profile exists for TB-500 in humans; the nearest tolerability data belong to the full protein given intravenously, topically or as eye drops.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","grade":"absence-of-evidence","grade_label":"Absence of evidence"},{"id":"TB-150","text":"No population has been studied for TB-500: no data exist in pregnant or breastfeeding people, children, people with cancer, people with cardiovascular disease outside the recruiting safety study, or people with immune conditions.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","grade":"absence-of-evidence","grade_label":"Absence of evidence"},{"id":"TB-151","text":"No drug interaction study of TB-500 exists in any species.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","grade":"absence-of-evidence","grade_label":"Absence of evidence"},{"id":"TB-160","text":"Analysis of products purchased over the internet found that the content of TB500 and TB1000 products is not systematically consistent with its former descriptions, and that a comparator product (SGF1000) was mainly sheep extracellular matrix and blood proteins with the purported growth promoters excessively diluted.","source_url":"https://europepmc.org/article/MED/36482504","grade":"analytical","grade_label":"Analytical study"},{"id":"TB-161","text":"Researchers studying TB-500 have had to synthesise authentic reference standards themselves, and a 2024 paper states that TB-500 and its metabolites had never previously been simultaneously quantified or structurally identified using synthesised authentic standards.","source_url":"https://europepmc.org/article/MED/22962027","grade":"analytical","grade_label":"Analytical study"},{"id":"TB-162","text":"There is no USP monograph, no pharmaceutical-grade formulation and no validated quality standard for TB-500 vials.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","grade":"absence-of-evidence","grade_label":"Absence of evidence"},{"id":"TB-170","text":"No validated storage or reconstitution standard exists for TB-500 because no pharmaceutical-grade formulation of it exists.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","grade":"absence-of-evidence","grade_label":"Absence of evidence"},{"id":"TB-171","text":"By contrast the recombinant human thymosin beta-4 injection under clinical study is specified as a sterile solution supplied in 1.5 mg (1 mL) vials stored at 2 to 8 degrees Celsius and diluted to a 5 mL administration volume.","source_url":"https://clinicaltrials.gov/study/NCT07586865","grade":"registry","grade_label":"Registry record"},{"id":"TB-183","text":"A fragment sharing an active site with its parent protein is a hypothesis about the fragment rather than evidence about it; no source in this pack demonstrates therapeutic equivalence between TB-500 and thymosin beta-4 in any species.","source_url":"https://europepmc.org/article/MED/12581423","grade":"absence-of-evidence","grade_label":"Absence of evidence"}]}