Summary
TB-500 is the name under which synthetic thymosin beta-4, a repair protein found in nearly all human cells, or its 7 amino acid active fragment, is sold for injection. Thymosin beta-4 itself has solid animal data for wound healing and cardiac repair and has small phase 1 and phase 2 human trials, which are early stage studies (IV safety, eye drops for dry eye, topical gel for skin ulcers), none of which tested injected TB-500 for injury healing. A 72 person dry eye trial missed its primary endpoints (its main goals), and two intravenous (into a vein) phase 1 studies in healthy volunteers found it well tolerated. No human trial of injected TB-500 exists, so PeptideAgent grades the injectable product animal-only. FDA removed it from the 503A Category 2 list (compounding ingredients flagged for significant safety risks) in April 2026 and its advisory committee recommended it for the 503A bulks list (ingredients pharmacies may use to compound drugs for individual patients) in July 2026, but no final rule has been published, and it is prohibited by WADA under section S2.
What is TB-500 (thymosin beta-4)?
TB-500 (thymosin beta-4) is a synthetic version or fragment of thymosin beta-4, a 43 amino acid actin sequestering peptide present in nearly all human cells. It is also known as Thymosin beta-4, Tβ4, Tbeta4, TB4, TB 500, thymosin beta 4 fragment 17-23 (LKKTETQ), RGN-259 (ophthalmic thymosin beta-4), TB500, TB-500 peptide, Thymosin beta 4.
How does it work?
Thymosin beta-4 is the main actin sequestering protein in mammalian cells, binding monomeric G-actin and regulating cytoskeletal assembly needed for cell migration. In animal models it promotes keratinocyte, endothelial, and cardiomyocyte migration, reduces inflammation and myofibroblast driven scarring, and forms a complex with PINCH and integrin linked kinase (ILK) that activates the survival kinase Akt. The 7 amino acid fragment LKKTETQ (residues 17 to 23) contains the actin binding motif and is what some TB-500 products claim to contain. These mechanisms are documented in rodent and cell work, not in humans receiving the injectable product.
| Cluster | Tissue repair and healing |
|---|---|
| Routes | Subcutaneous or intramuscular injection (as sold); Topical eye drops (human dry eye trial, investigational); Topical to wound or intraperitoneal (animal studies) |
| Conditions studied | Tendon injury and tendinopathy; Muscle recovery and injury; Wound healing; Traumatic brain injury; Osteoarthritis |
| Record | v3, draft, verified Sep 23, 2026 |
TB-500 benefits: what the evidence shows
Rodent studies show thymosin beta-4 accelerates full thickness wound closure (reepithelialization up 42% at 4 days and 61% at 7 days in rats) and improves cardiac function after coronary ligation in mice. Human efficacy data come from small phase 2 trials of full-length thymosin beta-4: a 0.1% eye drop in 72 people with dry eye, where neither primary endpoint reached significance though some secondary endpoints did, and a topical gel in venous stasis and pressure ulcers, where a review of two trials reported faster healing in patients who healed. Two phase 1 studies of intravenous full length thymosin beta-4 in healthy volunteers found it well tolerated but did not test healing. No human trial of subcutaneous or intramuscular TB-500 for musculoskeletal injury has been published, and the identity of what is sold as TB-500 (full length peptide versus fragment) is not verified. The eye drop and intravenous studies used different formulations and purposes from injected TB-500; they are listed but do not raise the grade.
| Evidence type | Indexed studies | Participants (human) |
|---|---|---|
| Human randomized trials | 3 | 196 |
| Human observational studies | 0 | n/a |
| Animal studies | 3 | n/a |
| All indexed studies | 6 | 196 |
Human evidence
No indexed human trial of injected TB-500 products identified. The closest efficacy evidence is a single center, double masked, placebo controlled phase 2 trial of 0.1% thymosin beta-4 ophthalmic solution in 72 adults with moderate to severe dry eye for 28 days: the primary endpoints (ocular discomfort and inferior corneal staining) were not significantly different from placebo, while discomfort in the adverse environment challenge fell 27% relative to placebo and several other secondary endpoints improved. Two randomized, placebo controlled phase 1 studies gave intravenous full length thymosin beta-4 to healthy volunteers (40 people for 14 days in 2010, and 54 single dose plus 30 multiple dose participants in 2021) and reported only mild to moderate adverse events with no dose limiting toxicity; both were safety studies for heart attack drug development, not tests of healing. A review of two phase 2 trials of a topical thymosin beta-4 gel in venous stasis and pressure ulcers reported faster healing, by almost a month, in patients who healed. None of these studies tested injected TB-500 for muscle, tendon, or joint injury.
Animal evidence
In a rat full thickness wound model, thymosin beta-4 given topically or intraperitoneally increased reepithelialization by 42% at day 4 and up to 61% at day 7, increased wound contraction, collagen deposition, and angiogenesis, and stimulated keratinocyte migration 2 to 3 fold in vitro at picogram amounts. In mice with coronary artery ligation, thymosin beta-4 upregulated ILK and Akt activity, enhanced early cardiomyocyte survival, and improved cardiac function. Additional rodent and cell studies summarized in reviews report reduced scarring and fibrosis, and effects in corneal injury and brain injury models.
Key studies
| Study | Design and population | Outcome | Grade |
|---|---|---|---|
| Thymosin beta4 accelerates wound healing1999 PMID 10469335 | Rat full thickness wound model plus keratinocyte migration assayRats and cultured keratinocytes | Reepithelialization increased 42% at day 4 and up to 61% at day 7 versus saline; more contraction, collagen, and angiogenesis; keratinocyte migration up 2 to 3 fold | Evidence: Animal-only evidence |
| Thymosin beta4 activates integrin-linked kinase and promotes cardiac cell migration, survival and cardiac repair2004 PMID 15565145 | Mouse coronary artery ligation model plus embryonic and postnatal cardiomyocyte cultureMice and cultured cardiomyocytes | Thymosin beta-4 formed a complex with PINCH and ILK, activated Akt, enhanced early myocyte survival, and improved cardiac function after infarction | Evidence: Animal-only evidence |
| Thymosin beta 4 ophthalmic solution for dry eye: a randomized, placebo-controlled, phase II clinical trial2015 PMID 26056426 | Single center, double masked, placebo controlled phase 2 trial, 28 days of treatmentn = 72 Adults with moderate to severe dry eye | Neither primary endpoint (ocular discomfort, inferior corneal staining) significantly different from placebo; several secondary endpoints improved, including 27% lower discomfort in the adverse environment challenge | Evidence: Human RCT evidence |
| Thymosin beta4: a multi-functional regenerative peptide. Basic properties and clinical applications2012 PMID 22074294 | Narrative reviewAnimal models of skin, eye, heart, and brain injury and early clinical programs | Summarizes actin binding, cell migration, anti-inflammatory, and anti-fibrotic mechanisms and the rationale for clinical trials in wounds, cornea, heart, and CNS | Evidence: Animal-only evidence |
| A randomized, placebo-controlled, single and multiple dose study of intravenous thymosin beta4 in healthy volunteers2010 PMID 20536472 | Randomized, placebo controlled phase 1 ascending dose study, single dose then 14 daily dosesn = 40 Healthy adult volunteers | Adverse events infrequent and mild to moderate; no dose limiting toxicity or serious adverse events; safety study only, healing not tested | Evidence: Human RCT evidence |
| A first-in-human, randomized, double-blind, single- and multiple-dose, phase I study of recombinant human thymosin beta4 in healthy Chinese volunteers2021 PMID 34346165 | Randomized, double blind phase 1 study, single and multiple intravenous dosesn = 84 Healthy adult volunteers (54 single dose, 30 multiple dose) | Adverse events mild to moderate; no dose limiting toxicity or serious adverse events; no accumulation with daily dosing; safety study only | Evidence: Human RCT evidence |
Conditions studied
| Condition | Grade | Note |
|---|---|---|
| Tendon injury and tendinopathy | Evidence: Animal-only evidence | Cell migration and wound closure effects in animal and cell models; no human RCT for tendon injury. |
| Muscle recovery and injury | Evidence: Animal-only evidence | Cell migration and anti-inflammatory effects in animal models; no human trial for muscle injury. |
| Wound healing | Evidence: Animal-only evidence | Thymosin beta-4 promoted wound closure in animal models; human trials in other indications were inconclusive. |
| Traumatic brain injury | Evidence: Animal-only evidence | Thymosin beta-4 improved functional recovery and brain remodeling in rats after TBI; no human TBI study. |
| Osteoarthritis | Evidence: Animal-only evidence | Animal tissue repair data only; no joint study in humans. |
Is TB-500 (thymosin beta-4) legal in the United States?
FDA and compounding status
Removed from the FDA 503A Category 2 list (substances nominated for compounding that raise significant safety risks) on April 15, 2026. On July 23 to 24, 2026 the Pharmacy Compounding Advisory Committee recommended adding TB-500 to the 503A bulks list. As of the last verification date FDA has not published a final rule listing it, so it is not on the 503A bulks list and a 503A pharmacy has no federal basis to compound it from bulk; state boards cannot authorize what federal law does not. It is not an FDA approved drug and is not eligible for 503B outsourcing. Products sold as research chemicals are not lawful for human use.
WADA status
WADA prohibited. Athletes subject to anti-doping testing should treat this as prohibited at all times unless the current prohibited list says otherwise.
Regulatory timeline
- WADA
WADA publishes the 2027 Prohibited List
WADA published the 2027 Prohibited List on September 21, 2026, and it takes effect January 1, 2027. The S2 peptide hormone and growth factor classes are unchanged. BPC-157 is still named under S0, and MOTS-c is still named under S4.4 as an activator of AMP-activated protein kinase. WADA added a note that many peptides without approval for human use fall under S0 or another section, and that a peptide not named on the list may still be prohibited. GLP-1 receptor agonists such as semaglutide and tirzepatide are still not on the list.
- PCAC
PCAC recommends six peptides for the 503A bulks list
At its July 23 to 24, 2026 meeting, FDA's Pharmacy Compounding Advisory Committee voted to recommend that BPC-157, KPV, TB-500, MOTS-c, semax, and epitalon be added to the 503A bulk drug substances list. A committee recommendation is advisory; FDA must still issue a rule before the substances are formally listed.
Regulatory: Under FDA reviewSource: Pharmacy Compounding Advisory Committee - FDA
FDA lists BPC-157 and 16 other peptides as withdrawn from 503A Category 2
FDA's Category 2 page, revised in April 2026 and current as of April 22, 2026, moved BPC-157, AOD-9604, CJC-1295, dihexa, DSIP, epitalon, injectable GHK-Cu, ipamorelin, KPV, LL-37, melanotan II, MOTS-c, PEG-MGF, selank, semax, thymosin alpha-1, and thymosin beta-4 fragment (TB-500) to a list of bulk drug substances nominated but withdrawn by their nominators. A withdrawn substance is no longer in 503A Category 2, but withdrawal is not an approval and does not place a substance on the 503A bulks list; a 503A pharmacy still needs a listing before it may compound it. Ipamorelin acetate remains in 503B Category 2. Seven of the withdrawn peptides (BPC-157, KPV, TB-500, MOTS-c, semax, epitalon, and DSIP) were taken to the Pharmacy Compounding Advisory Committee in July 2026.
- WADA
WADA 2026 Prohibited List takes effect
The 2026 WADA Prohibited List took effect on January 1, 2026 and continues to prohibit the S2 peptide hormone and growth factor classes (GHRH analogs, growth hormone secretagogues, GH fragments, IGF-1 and analogs, MGF, thymosin beta-4 and derivatives, hCG and GnRH-class releasing factors in males), myostatin inhibitors, insulin and the AMPK activator MOTS-c under S4, desmopressin under S5, and BPC-157 under S0. GLP-1 receptor agonists such as semaglutide and tirzepatide are not on the list.
- WADA
WADA 2025 Prohibited List keeps peptide hormones and growth factors banned at all times
The 2025 WADA Prohibited List took effect on January 1, 2025. Section S2 (peptide hormones, growth factors, related substances and mimetics) covers GHRH analogs such as CJC-1295, sermorelin, and tesamorelin, growth hormone secretagogues such as ipamorelin, GHRP-2, GHRP-6, hexarelin, and ibutamoren (MK-677), growth hormone fragments such as AOD-9604, growth factors including IGF-1 and its analogs, MGF, and thymosin beta-4 (TB-500), and chorionic gonadotropin and releasing factors such as gonadorelin and kisspeptin (prohibited in males). Myostatin inhibitors such as ACE-031 fall under S4, insulin under S4 metabolic modulators, desmopressin under S5, and BPC-157 remains an S0 non-approved substance.
- FDA
FDA places a batch of nominated peptides in 503A Category 2
In September 2023 FDA updated its 503A bulk drug substances category lists to place a group of nominated peptides in Category 2, which means FDA identified significant safety risks and the substances may not be used in 503A compounding while the evaluation continues. Kisspeptin-10 and ibutamoren (MK-677) were added on September 29, 2023 and remain in Category 2 on the FDA page current as of April 22, 2026. BPC-157, CJC-1295, ipamorelin, AOD-9604, dihexa, DSIP, epitalon, KPV, MOTS-c, selank, semax, melanotan II, LL-37, thymosin alpha-1, and thymosin beta-4 fragment (TB-500) were also placed in Category 2 under the 503A interim policy; that same page now lists them as nominated but withdrawn (see the April 2026 event). Hexarelin, PNC-27, and 5-amino-1MQ have never appeared on the FDA category lists.
Full tracker for TB-500 (thymosin beta-4) or the category-wide tracker.
What published studies of TB-500 (thymosin beta-4) used
Ranges below are reported from published studies and labeling only. PeptideAgent does not recommend doses or protocols.
Not established in human literature for the injectable. Human studies tested thymosin beta-4 only as eye drops for dry eye and as intravenous infusions in phase 1 safety studies, and rodent wound studies used topical application or intraperitoneal injection; none of these translate to a human injectable dose, and no human dose finding study for TB-500 has been published.
Routes reported
| # | Route |
|---|---|
| 1 | Subcutaneous or intramuscular injection (as sold) |
| 2 | Topical eye drops (human dry eye trial, investigational) |
| 3 | Topical to wound or intraperitoneal (animal studies) |
TB-500 side effects
Side effects
| # | Reported side effect |
|---|---|
| 1 | No human safety data for injected TB-500 products |
| 2 | Two phase 1 intravenous studies of full length thymosin beta-4 in healthy volunteers: mild to moderate adverse events, no serious adverse events or dose limiting toxicity |
| 3 | Eye drop trial: no significant safety findings over 28 days |
| 4 | Injection site reactions, headache, and lethargy reported anecdotally |
| 5 | Theoretical cancer concern: thymosin beta-4 drives cell migration and angiogenesis, and higher tumor levels are associated with invasion and metastasis in colorectal cancer studies (not shown to be caused by taking it) |
Interactions
| # | Interaction |
|---|---|
| 1 | No formal human interaction studies exist |
| 2 | No specific drug interactions have been described in animal work |
Contraindications
| # | Contraindication |
|---|---|
| 1 | Active cancer or history of cancer (theoretical cell migration and angiogenesis concern) |
| 2 | Pregnancy and breastfeeding (no data) |
| 3 | Competitive athletes subject to WADA testing (prohibited at all times under S2) |
How do people access TB-500 (thymosin beta-4) legally?
Typical cost: No lawful compounded price: TB-500 is not on the 503A bulks list, and PCAC's July 2026 recommendation is advisory until FDA publishes a final rule. Advertised clinic prices are not a comparable price. Products sold as research chemicals are not lawful for human use and are not verified for identity or purity.
Verified access options
Step 1
No lawful compounded access path yet: PCAC recommended it for the 503A bulks list in July 2026, but until FDA publishes a final rule a 503A pharmacy has no federal basis to compound it from bulk.
Step 2
Not available as an FDA approved product.
Step 3
Products labeled research use only are not lawful for human use and are not verified for purity.
Access paths are verified against public regulatory records and prescriber licensing. We never list unlicensed vendors.
Compare TB-500 (thymosin beta-4)
What's actually offered, and what that means for you
Licensed compounding pharmacies, clinics, and telehealth prescribers openly offer many unapproved peptides, and prescribers write prescriptions for them. That does not make TB-500 (thymosin beta-4) lawful. FDA's advisory committee recommended TB-500 (thymosin beta-4) for the 503A bulks list in July 2026, but FDA has not published a final rule, so a pharmacy has no federal basis to compound it yet. [5] [6]
Enforcement is uneven. FDA mostly acts through warning letters to compounders and online sellers, Category 2 safety listings, and import alerts that let it detain shipments, rather than stopping every pharmacy. State pharmacy boards oversee pharmacies day to day, and their rules differ. [13] [14] [15] [16] [17]
What changes for you
- No FDA review of the product: FDA does not check a compounded drug's safety, effectiveness, or quality before it is sold. [17]
- Identity, purity, sterility, and dose accuracy can vary from batch to batch. [15]
- Insurance rarely covers it, so you usually pay cash.
- For tested athletes, TB-500 (thymosin beta-4) is prohibited at all times on the WADA list, whatever the source. [7]
What to check
These checks lower some risks, but they do not make an unlawfully compounded product lawful or safe. Check for:
- A 503A pharmacy licensed in your state (your state board of pharmacy publishes license lookups). [17]
- A real evaluation by a licensed prescriber, not just an online form.
- A certificate of analysis for the specific batch.
Blends that contain TB-500 (thymosin beta-4)
TB-500 (thymosin beta-4) is sold in premixed blends under the names below. No blend has been tested as a combination, and a mix is only as lawful as its least lawful ingredient.
- GLOW: with GHK-Cu, BPC-157. No lawful path.
- KLOW: with GHK-Cu, BPC-157, KPV. No lawful path.
- Wolverine stack: with BPC-157. Awaiting FDA final rule.
Frequently asked questions
What is TB-500?
TB-500 is the name used for synthetic thymosin beta-4, a 43 amino acid repair protein found in nearly all human cells, or for a short fragment of it. It is promoted for tendon, muscle, and wound healing on the strength of animal studies. It is not an FDA approved drug, it is named on the WADA Prohibited List (the World Anti-Doping Agency's banned list), and PeptideAgent grades the injectable product animal-only. [4] [7] [11]
TB-500 benefits: what does the evidence show?
In animals, thymosin beta-4 clearly speeds wound closure (42% more reepithelialization at day 4 in rats) and improves heart function after injury in mice (animal-only evidence). In humans, full-length thymosin beta-4 has small phase 1 and phase 2 trials (IV safety, eye drops for dry eye, topical gel for skin ulcers): the 72 person dry eye trial missed its primary endpoints, and a review of two skin ulcer trials reported faster healing in patients who healed. No human trial of injected TB-500 for tendon, muscle, or ligament injury has been published, so the benefits people seek it for are unproven. [1] [2] [3] [12]
What are the side effects of TB-500?
There is no human safety data for injected TB-500 products. The closest data come from two phase 1 studies of intravenous full length thymosin beta-4 in healthy volunteers, which reported mild to moderate adverse events and no serious ones, and a 28 day eye drop trial that raised no safety concerns. Anecdotal reports mention injection site irritation, headache, and lethargy. Unverified research chemical products add contamination and identity risks. [3] [8] [9] [11]
Does TB-500 cause cancer?
No study shows that taking it causes cancer, but the question has not been tested. The concern comes from tumor biology: thymosin beta-4 drives cell migration and blood vessel growth, and in colorectal cancer research higher thymosin beta-4 made cancer cells more invasive and was found at higher levels in liver metastases. That is an association in tumors, not proof that an injected dose causes harm, and the phase 1 studies were too short to detect a cancer signal. People with active or past cancer are the group the concern applies to most. [4] [8] [10]
TB-500 vs thymosin beta-4: are they the same?
Not necessarily. Thymosin beta-4 is a natural 43 amino acid protein. TB-500 is a trade style name used both for synthetic full length thymosin beta-4 and for a 7 amino acid fragment (LKKTETQ, residues 17 to 23) that contains its actin binding site. Sellers are inconsistent about which they supply, and the animal and human research used the full length peptide, so its results may not apply to fragment products. [4] [11]
Are there TB-500 capsules or nasal sprays?
Oral and nasal TB-500 products are marketed, but no human study has tested thymosin beta-4 by mouth or by nasal spray. The human studies used intravenous infusion, eye drops, and a topical gel on skin ulcers, and the animal wound and heart studies applied it to wounds or injected it. There is no evidence that a capsule or spray delivers the peptide to injured muscle, tendon, or skin. [1] [3] [8] [12]
Is TB-500 FDA approved?
No. TB-500 is not FDA approved for any use. FDA removed it from the 503A Category 2 list on April 15, 2026, and the Pharmacy Compounding Advisory Committee recommended it for the 503A bulks list in July 2026, but that vote is advisory. Until FDA publishes a final rule, a 503A pharmacy has no federal basis to compound it from bulk, and state boards cannot authorize what federal law does not. Products sold as research chemicals are not lawful for human use. [5] [6]
Is TB-500 banned by WADA?
Yes. The WADA Prohibited List names thymosin beta-4 and its derivatives, including TB-500, under section S2 (peptide hormones, growth factors, related substances and mimetics), prohibited at all times. Athletes subject to testing should not use it. [7]
Decisions about starting, stopping, or combining any treatment belong with a licensed clinician who knows your history.
From the blog
- TB-500 vs thymosin beta-4: is it the same peptide?
TB-500 is not the same molecule as thymosin beta-4. What each one is, which has human data, what is known about capsules and sprays, and what the evidence says about cancer.
- Klow vs Glow peptide: what KPV adds and what is known
Klow is the Glow blend (GHK-Cu, BPC-157, TB-500) plus KPV. Each ingredient compared, what KPV is claimed to add, how both relate to the Wolverine stack, and why no study tests either blend.
- Peptide before and after: trial results vs marketing photos
Measured peptide before and after results: GLP-1 weight change, tesamorelin visceral fat, and regain after stopping, compared with Glow, GHK-Cu, BPC-157, and Wolverine claims.
- Peptide stacks: what each common component has shown alone
No trial has tested a multi-peptide stack for muscle growth or fat loss. Nine common stack components ranked by their own human evidence, legal status, and WADA status. No protocols.
- How to read a peptide study
A practical checklist for judging peptide research: who was studied, how it was designed, what was measured, and whether it was replicated. Worked through with real studies.
- PCAC recommended six peptides. What changes and what does not
FDA's compounding advisory committee backed BPC-157, KPV, TB-500, MOTS-c, semax, and epitalon for the 503A bulks list and rejected DSIP. Here is what the vote does and does not do.
More on the blog
Sources
Numbered citations above point to these primary sources. PubMed entries link to the indexed abstract.
- [1]Malinda KM et al. Thymosin beta4 accelerates wound healing. J Invest Dermatol 1999PubMed 10469335, 1999
- [2]Bock-Marquette I et al. Thymosin beta4 activates integrin-linked kinase and promotes cardiac cell migration, survival and cardiac repair. Nature 2004PubMed 15565145, 2004
- [3]Sosne G et al. Thymosin beta 4 ophthalmic solution for dry eye: a randomized, placebo-controlled, phase II clinical trial. Clin Ophthalmol 2015PubMed 26056426, 2015
- [4]Goldstein AL et al. Thymosin beta4: a multi-functional regenerative peptide. Basic properties and clinical applications. Expert Opin Biol Ther 2012PubMed 22074294, 2012
- [5]FDA: Bulk drug substances used in compounding under section 503A of the FD&C Act (links to the Category 1, 2, and 3 lists and the bulks list)FDA, 2026
- [6]FDA Pharmacy Compounding Advisory Committee meetings (July 2026 meeting on peptide nominations)FDA, 2026
- [7]WADA Prohibited List, section S2 peptide hormones, growth factors, related substances and mimetics (names thymosin beta-4 and TB-500)WADA, 2026
- [8]Ruff D et al. A randomized, placebo-controlled, single and multiple dose study of intravenous thymosin beta4 in healthy volunteers. Ann N Y Acad Sci 2010PubMed 20536472, 2010
- [9]Wang X et al. A first-in-human, randomized, double-blind, single- and multiple-dose, phase I study of recombinant human thymosin beta4 in healthy Chinese volunteers. J Cell Mol Med 2021PubMed 34346165, 2021
- [10]Wang WS et al. Overexpression of the thymosin beta-4 gene is associated with increased invasion of SW480 colon carcinoma cells and the distant metastasis of human colorectal carcinoma. Oncogene 2004PubMed 15235586, 2004
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<a href="https://peptideagent.ai/peptides/tb-500">TB-500 (thymosin beta-4): evidence, legality, and access</a>, PeptideAgent, updated September 23, 2026.