
Hepatitis B
A 2026 Cochrane review of 10 randomized trials in chronic hepatitis B found Ta1 may lower deaths from any cause, but rated the certainty of that evidence very low.11

Thymalfasin, Ta1, Zadaxin
Thymosin alpha-1 was found in 1972 as the thymus factor that restored immunity in mice without a thymus. Its largest modern trial hints that it helps some immune systems and not others.
Free to join · One email when peptide care opens · Most lab results in 3–5 business days
Thymosin alpha-1 (thymalfasin, Zadaxin) is a 28-amino-acid peptide first isolated from the thymus, the organ where T cells mature. It activates dendritic cells, the sentinels that tell T cells how to respond. It is used abroad for hepatitis B and C, in more than 35 countries according to published reviews, and studied for vaccine response and sepsis, where the largest trial found no clear benefit.
Medically reviewed by Robert Lufkin, MD (opens in a new tab)
Chief Medical Officer, Vitals Vault · Updated · 15 sources
Ta1 is an immune modulator. It tunes the signals that start and shape an immune response.
It switches on dendritic cells, the immune system’s sentinels, which then steer T cells toward attacking viruses and fungi.32
In a special type of dendritic cell, it drives production of interferons, the signals the body uses against viruses.4
It also raised an enzyme linked to tolerance, so researchers call it a regulator of both inflammation and immunity.4
The human evidence is real but uneven. It is strongest for hepatitis, mixed for sepsis and early for vaccines and COVID-19.
Switched on immune sentinel cells, which then released a signal that steers T cells against viruses and fungi.32
Shows a mechanism
In mice, it sped immune recovery after bone marrow transplant and protected against a lung fungus and a virus.34
Shows an effect in a body
Strongest for hepatitis B, where a Cochrane review found possible lower mortality at very low certainty. A 1,106-person sepsis trial found no clear effect.1110
Shows it works in people
The 2025 TESTS trial is the most rigorous test so far. Across 22 Chinese centers, 28-day mortality was 23.4% on Ta1 and 24.1% on placebo, a hazard ratio of 0.99. The authors found no clear evidence that it lowers mortality in sepsis, and a subgroup analysis hinted at different effects by age and diabetes status that need confirming.1011
In chronic hepatitis B, the 2026 Cochrane review pooled 10 randomized trials with 1,349 participants. It found signals of lower mortality and fewer serious adverse events, but the certainty of evidence was low or very low for every outcome. The evidence supports more research, not a firm conclusion.1011
The full guide to Thymosin alpha-1
Take the thymus out of a young mouse and its immune defenses falter, because the thymus is where T cells learn their job. In the search for what this small gland behind the breastbone was releasing, Allan Goldstein described thymosin alpha-1 in 1972. It was isolated as the compound that restored immune function to mice whose thymus had been removed.
The thymus is busiest in childhood and shrinks steadily through adult life, which is one reason immune responses weaken with age. Ta1 became a candidate for exactly that problem, as a way to give a tired immune system some of the signal a younger thymus would supply.
Chemically it is a chain of 28 amino acids, and the drug version is made synthetically under the name thymalfasin, sold as Zadaxin. By 2001, a pharmacy review reported it in phase 3 trials for hepatitis C and phase 2 for hepatitis B. According to published reviews it is now approved in more than 35 countries for chronic hepatitis B and C.
Later work added a twist to the origin story. Ta1 is cut from a larger protein, prothymosin alpha, in many different mammalian tissues, so it is not only a thymus product. Researchers in Perugia called it an endogenous regulator of immune balance, a signal the body makes for itself across many organs.42651
Dendritic cells are the immune system’s scouts. They sit in skin, lungs and gut, sample what they find, and then brief T cells on whether to attack and how. In 2004, a team in Perugia showed that Ta1 acts on these scouts through Toll-like receptors, the sensors that recognize microbes.
Once triggered, the cells switched on the p38 and NF-kappaB signaling pathways and released interleukin-12, the cytokine that pushes T cells toward a T-helper 1 response, the kind suited to viruses and fungi. In mice given bone marrow transplants, a group highly vulnerable to a lung fungus called Aspergillus, Ta1 sped up immune cell recovery and protected them from infection.
A second pathway runs through plasmacytoid dendritic cells, specialists in viral defense. Here Ta1 worked through TLR9 and interferon regulatory factor 7, which drives type I interferons, and it protected mice from a cytomegalovirus infection. A third effect points the other way. Ta1 raised indoleamine 2,3-dioxygenase, an enzyme that promotes tolerance, and in mice that translated into transplant tolerance and protection from allergic inflammation.
That mix explains the label immune modulator. Ta1 can sharpen defenses and also restrain them, depending on the setting. In people, it reaches peak blood levels within about two hours and blood levels return to baseline within 24 hours, with a serum half-life of about two hours. It is a short-lived molecule in the blood, which is why it is given on a repeating schedule.345
Hepatitis is where Ta1 built its career. A 2001 pharmacy review counted 195 hepatitis B patients across four trials. In one randomized trial, the virus’s DNA cleared from the blood in 40.6% of patients after six months of Ta1 and 25.6% after twelve months, against 9.4% of untreated controls.
Hepatitis C was less clear. Ta1 alone did not normalize the liver enzyme ALT better than placebo in one trial. Added to interferon, it did better than interferon alone in two others: in one, 71% of patients on the combination had a normal ALT at six months, against 35% on interferon, and viral RNA cleared in 65% against 29%. The reviewers called the overall results mixed.
In 2026, a Cochrane review took the most careful look yet at hepatitis B. It found 10 randomized trials with 1,349 participants, conducted in six countries and published between 1991 and 2018. Ta1 may lower all-cause mortality and serious adverse events, but the certainty was very low for mortality and low for serious events, largely because of bias risk and small numbers.
The authors found no ongoing trials, and 16 more studies could not be assessed because of incomplete reporting. So the hepatitis evidence is decades deep and still uncertain, which is a fair summary of Ta1 as a whole.511
Flu vaccines work less well as people age, and the immunization failure rate in older adults may be as high as 50%. That makes vaccine response a clean test for an immune modulator. If Ta1 helps an aging immune system, it should show up as more antibodies after a shot.
In 1989, researchers ran a double-blind, placebo-controlled trial in 90 men aged 65 to 99, average age 77, who received Ta1 or placebo alongside that year’s flu vaccine. Ta1 augmented the antibody response, and no toxicity was seen in either group. A later review by the same researchers, one of them at the National Institute on Aging, described enhanced vaccine responses in both animal and human trials.
The same idea was tested in people on hemodialysis, whose kidney failure blunts immunity. In a 2012 pilot of about 100 patients given a pandemic H1N1 vaccine, both Ta1 groups had stronger antibody responses at day 21 than the vaccine-only group and met the European licensing criteria. By day 42, though, their antibody levels had fallen faster, a detail worth noting for anyone imagining lasting protection.
The 2007 review also offered a helpful bit of perspective. The immune decline of aging is usually not profound on its own; what tips older people into real vulnerability is chronic illness and the medicines used to manage it. That is where an immune nudge has the most room to matter.798
Sepsis is the body’s runaway response to infection, and in its later stages the immune system can become exhausted and suppressed. Smaller trials had suggested Ta1 might help, so a team led from Sun Yat-sen University set up the definitive test, the TESTS trial, published in The BMJ in January 2025.
It enrolled 1,106 adults with sepsis at 22 centers in China between 2016 and 2020, randomized to a short course of Ta1 injections or placebo in intensive care. At 28 days, 23.4% of the Ta1 group had died and 24.1% of the placebo group, a hazard ratio of 0.99. No secondary or safety outcome differed significantly between the groups.
The trial received support from SciClone Pharmaceuticals, a drug company, and still reported a null result, which makes the finding harder to wave away. For sepsis as a whole, the trial found no clear evidence that Ta1 improved 28-day survival, though its confidence interval cannot rule out a modest effect either way.10
The headline was null, but the trial had planned to look at two subgroups in advance, and both lit up. In patients aged 60 and over, the hazard ratio was 0.81, leaning toward benefit. In patients under 60, it was 1.67, meaning more deaths on Ta1 than on placebo. People with diabetes did better on Ta1, with a hazard ratio of 0.58, and those without diabetes did not.
Put that next to the vaccine work and a pattern suggests itself. Older adults and people with diabetes tend to have duller immune responses, and those are the groups where Ta1 has looked most helpful. A younger patient with sepsis may already have an immune system running hot. Adding a stimulus there could plausibly push the wrong way.
This is a hypothesis, and the authors were careful to say the subgroup effects need confirming. Subgroup results in a null trial are easy to over-read. But the pattern fits what Ta1 is, a modulator of immune signaling, and it is the most useful thing to understand about it.
That is why immune booster is a misleading label. A better question for any immune peptide is whose immune system, in what state, and pushed in which direction.1094
During the pandemic, Ta1 was tried in hospitalized COVID-19 patients, on the theory that it could help regulate an overactive immune response. A 2023 meta-analysis pooled 8 studies in moderate to critical illness and found lower mortality, a risk ratio of 0.59, with no difference in the need for ventilation or in hospital stay.
The results varied widely between studies, and the mortality benefit tracked study size and the sex mix of patients, both warning signs. The authors called for randomized trials to confirm it. Read alongside the sepsis trial, the COVID data are a reason for a proper trial and no more.
Reviews list a longer roster of uses studied over the decades, including immune deficiencies, certain cancers such as melanoma and liver cancer, drug-resistant tuberculosis and DiGeorge syndrome, a condition in which children are born with little or no thymus. These are research directions, and the evidence behind each is uneven.1215
Unlike most peptides people ask about, Ta1 has been through real clinical trials, including a Cochrane review and a phase 3 trial with more than a thousand patients. That makes it possible to say something more precise than early research.
One way to read those trials is by setting. Where the immune system was weakened, by age, kidney failure or chronic viral infection, some studies reported measurable but modest signals: more vaccine antibodies, more viral clearance, possibly fewer deaths in hepatitis B. Results were mixed, though, and where the test was a broad, acute illness in a mixed population, as in sepsis, no clear overall effect appeared. The trials do not show which immune traits predict who benefits.
The certainty is still limited. The hepatitis evidence is rated low to very low quality, the vaccine studies are small, and the COVID-19 data come from heterogeneous studies. What the record supports is further study in specific groups under medical supervision, rather than use as a general-purpose supplement. It does not yet offer a way to pick out who would benefit.11107812
Across its clinical history, Ta1 has been well tolerated. Most studies observed only local irritation at the injection site. The 1989 vaccine trial saw no toxicity, the dialysis pilot found no adverse event related to Ta1 and no change in blood counts or chemistry, and the sepsis trial found no difference in safety outcomes from placebo.
The compounded product is a separate question. FDA’s April 2026 compounding page says compounded Ta1 may carry a significant risk of immunogenicity, an immune reaction to the peptide itself or to impurities, and that the safety information is inadequate to judge the risks. An approved product made under drug standards and a vial of uncertain origin are different things.
Because Ta1 acts on immune cells, some people should speak with a specialist first: anyone with an autoimmune disease or an organ transplant, anyone taking immune-suppressing medicines, anyone with a current cancer or serious infection, and anyone pregnant or breastfeeding.5781013
No standard lab panel has been validated for choosing or monitoring Ta1, and the right tests depend on why it is being considered. What a general panel offers is context. A white blood cell count is the simplest window into your immune system, and a count that is too low or too high is something a clinician would want to understand before anyone adds an immune-active peptide.
Zinc is needed for normal immune function and T cell development; whether a low level matters, and how to address it, depends on the person. hs-CRP measures low-grade inflammation, which matters for a peptide that can tilt immune signaling either way. ALT is a liver enzyme that hepatitis C trials used as an outcome, and outside that setting it is general liver context rather than a Ta1 readout.
This is how Vitals Vault approaches peptide care. A blood panel comes first, a licensed clinician reviews your results and history, and any plan ends with a retest of the same markers.52
No thymosin alpha-1 product is FDA-approved in the US, even though it is approved abroad. FDA’s April 2026 compounding safety page lists it among substances previously in category 2 whose nominations were withdrawn, and still cites immunogenicity and incomplete safety data. Withdrawal is not approval.
FDA’s October 29, 2026 enforcement discretion covers six other peptides and does not include Ta1. Vials sold online as research use only are not made for people, and a clinic offering compounded Ta1 should be able to explain its legal basis.131415
Thymosin alpha-1 has more human trial data than most peptides in this guide, and the data say something specific. It is a modulator of immune signaling, with its clearest signals in hepatitis and in weakened immune systems, and a large sepsis trial showed that a general boost does not follow.
If you are curious about it, start with the basics a clinician can measure and fix, from zinc and vitamin D to sleep and vaccines. Then ask the question that matters for any immune peptide. Is my immune system underpowered, overactive or working fine, and what evidence would tell us which?11107
Any responsible conversation about thymosin alpha-1 starts with a health history, a baseline panel and a clinician’s view on whether there is an immune problem to address at all. Its current US status means a clinician would also explain what is and is not available.
On timing, the studies give a few anchors. Ta1 is cleared from the blood within a day, yet its effects in trials were measured over weeks to months. Vaccine antibody gains appeared by about three weeks after vaccination, and in one pilot they faded faster afterward. Hepatitis trials judged viral clearance at six and twelve months.587
Gravenstein et al., 19897
Randomized, double-blind, placebo-controlled · 90 men aged 65 to 99 receiving a flu vaccine
Ta1 augmented the vaccine antibody response with no toxicity
Limits: Men only; one vaccine season
Ancell et al., 20015
Review of hepatitis trials · 195 hepatitis B and 162 hepatitis C patients
Higher viral clearance in hepatitis B; better results with interferon in hepatitis C
Limits: Mixed results; small trials
Carraro et al., 20128
Pilot clinical trial · About 100 people on hemodialysis
Stronger antibody response to an H1N1 vaccine at day 21
Limits: Pilot; antibodies fell faster by day 42
Soeroto et al., 202312
Meta-analysis, 8 studies · Moderate to critical COVID-19
Lower mortality, no change in ventilation or hospital stay
Limits: High variation between studies; randomized trials still needed
Wu et al., 2025 (TESTS)10
Phase 3, double-blind, placebo-controlled · 1,106 adults with sepsis in 22 centers
No clear effect on 28-day mortality (23.4% vs 24.1%)
Limits: Subgroup signals by age and diabetes need confirming
Naing et al., 2026 (Cochrane)11
Systematic review, 10 randomized trials · 1,349 adults with chronic hepatitis B
May lower all-cause mortality and serious adverse events
Limits: Low to very low certainty evidence
It modulates immune signaling, which can stimulate or restrain. In the largest sepsis trial it made no overall difference, and patients under 60 did worse on it in a subgroup analysis.104
They share a name and little else. Thymosin alpha-1 is a 28-amino-acid immune modulator acting on dendritic cells. Thymosin beta-4 is a larger repair protein studied for wound and tissue healing.13
Smaller trials looked promising, but the 2025 BMJ phase 3 trial of 1,106 adults found 28-day mortality of 23.4% on Ta1 and 24.1% on placebo, with no clear benefit.10
Approval elsewhere does not carry over. FDA lists thymosin alpha-1 among withdrawn category 2 compounding nominations, still citing immunogenicity and safety-data concerns, and it is not covered by the October 2026 enforcement discretion.1315
There is no FDA-approved dose, because no thymosin alpha-1 product is approved in the US. In countries where it is approved for hepatitis B and C, the standard schedule is an injection under the skin twice a week, and trials in older adults and in sepsis used set schedules too, shown in the table. Do not rely on online dosing charts. Your clinician sets your dose.5710
Thymosin alpha-1 has been given to people as an injection under the skin, most often twice a week for chronic hepatitis B or C where it is approved outside the US. Trials have also used it twice weekly alongside a flu vaccine in older men and twice daily for a week in sepsis. No US label exists, and your clinician sets the actual dose.
Already have a prescribed dose? The peptide dosage calculator turns it into the units to draw on an insulin syringe.
Clinical practice report · Injection under the skin
1.6 mg (900 µg/m²)
Twice a week; hepatitis B treatment courses of 6 or 12 months were reported5
Adults with chronic hepatitis B or C, the schedule used where the drug (Zadaxin) is approved outside the US
Human trial · Injection under the skin
900 µg/m²
Twice a week for eight doses, given with a flu vaccine7
Men aged 65 to 99
Human trial · Injection under the skin
1.6 mg
Every 12 hours for up to 7 days10
Adults in intensive care with sepsis (dose from the full-text methods). No statistically significant reduction in 28-day mortality
A clinician makes the call. These are the questions they will ask first.
Vitals Vault peptide care starts with a blood panel and a licensed clinician, and ends with a retest.
Get early access to peptide careYour immune response depends on how well dendritic cells, T cells and the thymus talk to each other. With age that conversation gets quieter, and older adults respond less well to vaccines.
A peptide acts on one point in that network. The rest depends on ordinary inputs, such as sleep, zinc, activity and up-to-date vaccines. Labs show where yours stand before anyone adds anything.92
A blood test before you start and a retest after shows what actually changed for you. It is how Vitals Vault approaches every treatment.
No. No thymosin alpha-1 drug is FDA-approved in the US, although it is approved for hepatitis B and C in more than 35 other countries. FDA lists it among bulk substances previously in category 2 whose compounding nominations were withdrawn, and still cites immunogenicity and incomplete safety data. FDA’s October 2026 enforcement discretion covers six other peptides and not this one.1131415
1972
Allan Goldstein first describes thymosin alpha-1.4
1989
Double-blind trial shows Ta1 augments the influenza vaccine antibody response in older men.7
2001
Pharmacy review summarizes hepatitis B and C trials in more than 350 patients.5
2004
Study in the journal Blood shows Ta1 activates dendritic cells through Toll-like receptors.3
2012
Pilot study finds Ta1 improves an H1N1 vaccine response in dialysis patients.8
January 2025
BMJ phase 3 trial of 1,106 adults with sepsis finds no clear effect on 28-day mortality.10
April 2026
FDA’s compounding safety page lists thymosin alpha-1 among withdrawn category 2 nominations, with safety risks noted.13
September 2026
Cochrane review of 10 trials in chronic hepatitis B publishes, with very low certainty evidence.11
October 29, 2026
FDA grants enforcement discretion to six other peptides, which do not include thymosin alpha-1.15

Thymosin alpha-1 is approved in more than 35 countries for chronic hepatitis B and C. It is also studied as a vaccine adjuvant and in sepsis, cancer and COVID-19. It is not FDA-approved for any use in the US.
In research it improved vaccine antibody responses in older and dialysis patients and showed signals of lower mortality in hepatitis B. The largest trial in sepsis found no clear benefit, so claims of a general immune boost go beyond the evidence.
It signals through Toll-like receptors on dendritic cells, which increases interleukin-12 and interferon pathways that direct T cells against viruses and fungi. It also affects tolerance, so it is called an immune modulator.
The most common effect is irritation or redness at the injection site. FDA says compounded versions may carry an immunogenicity risk and that safety information is inadequate.
There is no FDA-approved dose in the US. Where it is approved for hepatitis B and C, the usual schedule is an injection under the skin twice a week, an influenza-vaccine trial used twice-weekly injections for eight doses, and a sepsis trial used injections every 12 hours for up to seven days. Online charts are not a substitute; your clinician sets your dose.
They are different peptides with different jobs. Thymosin alpha-1 is a 28-amino-acid immune modulator. Thymosin beta-4 is a 43-amino-acid repair protein studied for wounds, eyes and the heart.
The largest trial, 1,106 adults in 22 Chinese hospitals, found no clear difference in 28-day mortality. A subgroup analysis hinted at benefit in people over 60 and in people with diabetes, which still needs confirming.
No. No thymosin alpha-1 drug is FDA-approved in the US. It is approved for hepatitis B and C in more than 35 other countries. FDA lists it among withdrawn category 2 compounding nominations and still describes safety risks.
FDA’s October 2026 enforcement discretion covers six peptides and does not include thymosin alpha-1, whose compounding nomination was withdrawn from FDA’s category 2 list. Vials sold online as research use only are not made for people.
Vitals Vault is opening clinician-led peptide care that starts with a blood test. Join the peptides waitlist to hear first. Thymosin alpha-1 is not among the peptides FDA cleared for compounding in October 2026, so a clinician would review your history, labs and the current rules before suggesting anything.

Vitals Vault is opening peptide care that starts with your blood work, is prescribed by licensed US clinicians and ends with a retest. Join the waitlist to hear first.