TP-5, thymopoietin 32–36, ORF-15244; Timunox and Sintomodulina (Italy, no longer marketed)
Common dose
50 mg 3× weekly for 3–6 weeks (Italian label)
Cycle
One 6-week course
Form
Ready-made product
A synthetic five-amino-acid peptide (Arg-Lys-Asp-Val-Tyr) that copies the active part of thymopoietin, a thymus hormone that helps immature T cells mature. It is injected to support weakened immunity.
Evidence. Registered in China, where hospitals use injections for weakened immunity, including alongside cancer care, and formerly in Italy (Timunox, Sintomodulina) for immune deficiencies; no European product is authorized now. Controlled trials from the 1980s–90s were mixed: gains in some rheumatoid arthritis and eczema trials and in one HIV subgroup, but none in chronic hepatitis B (30 people) or in preventing infection after surgery (206). In 2019 China listed it among drugs whose hospital use is monitored to curb overuse.
What it’s used for
Approved uses first, then uses tested in people, then claims that rest on animal studies or user reports.
Inborn T-cell immune deficiencies
LabelItaly’s former label listed DiGeorge syndrome, severe combined immunodeficiency and similar defects, mostly in children. In an uncontrolled 1983 study of 26 patients, 6 improved; none with classic SCID or ataxia-telangiectasia did.
Recurrent infections with weakened immunity
LabelItaly’s former label listed chronic or recurrent infections such as herpes. In a 36-person placebo trial, cold-sore relapses fell from 1.6 to 0.4 a month, vs 1.4 to 0.8 on placebo.
Immune side effects of chemotherapy or radiation
LabelListed in Italy’s former label and used alongside cancer care in China. In a 100-person, four-arm Italian trial, febrile episodes were 52% on thymopentin vs 64% on placebo, not significant.
Poor hepatitis B vaccine response on dialysis
LabelItaly’s label listed use alongside vaccines. A 2006 meta-analysis of 11 small controlled studies (272 patients) found no overall gain; only higher-dose studies improved antibody response.
HIV infection
TrialMixed: in 352 adults on AZT, AIDS or death struck 2 vs 10 on placebo among long-term AZT users but 4 vs 0 among newer users; CD4 counts didn’t differ. Never approved.
Rheumatoid arthritis
TrialMixed: three placebo-controlled trials (41, 76 and 119 people) found better joint scores after 3 weeks of IV injections, one fading within 4 weeks of stopping; three Belgian studies found no benefit.
Atopic dermatitis (eczema)
TrialModest: in 100 patients, 6 weeks of daily injections cut severity scores more than placebo (p=0.04); a 39-person trial also favored it. Not approved for eczema.
Chronic hepatitis B
TrialNot effective in a 30-person Italian randomized trial: after a year, HBV DNA had cleared in 13% of treated patients vs 20% of controls.
Label: an approved use. Trial: tested in people, with the result.
Not approved in the US or EU; FDA granted an orphan designation for sarcoidosis in 2011, with no approval. Registered in China; formerly approved in Italy as Timunox and Sintomodulina, neither of which is on Italy’s or the EU’s medicines registers now.
Approval history
2000Italy: Sintomodulina: authorization dated June 2000, for immune deficiency uses
2019China: Thymopentin injections: listed among drugs monitored nationally for overuse
US compounding
Never nominated for US compounding: it isn’t on FDA’s 503A or 503B bulk lists or their Category 1, 2 or 3 lists (503A categories updated May 14, 2026).
European Union
No current authorization: no thymopentin product is in EMA’s Article 57 database (October 2026), and Italy’s Timunox and Sintomodulina are off AIFA’s register.
United Kingdom
No marketing authorization (MHRA).
Canada
No marketing authorization; no thymopentin product is listed in Health Canada’s Drug Product Database.
Australia
No marketing authorization. Thymopentin isn’t named in the Poisons Standard (June 2026).
Sport (WADA 2026)
Not banned in sportNot named on the 2026 list. S0 doesn’t apply because it’s a registered medicine in China, and it isn’t a hormone or growth factor covered by S2. WADA’s 2027 list doesn’t change this.
Category 2 is FDA’s list of bulk substances that may present significant safety risks in compounding. The 503A bulks list adds substances that pharmacies may compound with. Advisory committee votes are advice; FDA makes the final decision. Sport status follows the WADA Prohibited List in force since January 1, 2026; athletes should confirm with their anti-doping organization. Checked October 5, 2026. Status outside the US checked October 7, 2026 against EMA, MHRA, Health Canada and TGA records. By country: EU, UK, Canada, Australia. Status of every compound.
How it works
Thymopentin copies amino acids 32–36 of thymopoietin, a 49-amino-acid thymus hormone that helps immature T cells mature. Italy’s label says it drives the maturation of T-cell precursors through cyclic AMP, a chemical messenger inside cells, and regulates mature lymphocytes through cyclic GMP. Blood enzymes break it down within about 30 seconds, yet lymphocyte changes appear within 2 hours and can last 5 days after one IV dose.
LabelBased on the product label.
Not known
Its receptor isn’t settled: lab studies point to thymopoietin receptors on T-cell lines and to TLR2, an immune sensor. Why such a brief exposure has lasting effects, and why trials disagree, is unexplained.
Protocol
Label
Sintomodulina, Italian label
50 mg under the skin 3× a week for 3–6 weeks, for weakened immunity, side effects of chemotherapy or radiation, or alongside vaccines; the same dose by slow IV injection in autoimmune disease.
Trial
Goldstein 1995
50 mg under the skin 3× a week for 48 weeks in 352 adults with HIV taking AZT.
Trial
Chen 2025
10 mg under the skin daily for 5 days, then 3× a week for 23 weeks, in 100 adults on peritoneal dialysis (retrospective Chinese study).
Frequency
3× weekly (Italian label); daily or every other day in Chinese studies
Route
Subcutaneous or intramuscular injection (labels); slow IV injection in Italy’s label for autoimmune disease and in arthritis trials
Cycle
Italian label: a 3–6 week course, which a doctor may extend or repeat. HIV trials ran up to a year.
Week 15913172125
One 6-week course, shown over 26 weeks
Common protocols
The ways Thymopentin is most often run, each tagged with where it comes from.
Italian label course
Label
Dose
50 mg under the skin
How often
3× a week
How long
3–6 weeks
For weakened immunity, side effects of chemotherapy or radiation, or alongside vaccines. A doctor may extend or repeat it.
Italian label, autoimmune disease
Label
Dose
50 mg in 10 mL saline, IV over 10 minutes
How often
3× a week
How long
3–6 weeks
The label leaves autoimmune use to case-by-case judgment. Arthritis trials used this dose for 3 weeks.
HIV trial
Trial
Dose
50 mg under the skin
How often
3× a week
How long
48 weeks
352 adults on AZT; fewer AIDS events only in long-term AZT users (Goldstein 1995).
Chinese practice (dialysis study)
Trial
Dose
10 mg under the skin
How often
Daily for 5 days, then 3× a week
How long
24 weeks
Retrospective study of 100 adults on peritoneal dialysis (Chen 2025). Other Chinese reports use 10 mg every other day.
Taking it
Where it goes
Under the skin or into a muscle (labels). Italy’s label also allowed a slow IV injection over 10 minutes for autoimmune disease.
If you miss a dose
The labels give no missed-dose rule. On a 3×-weekly schedule, give the missed dose the next day and keep at least a day between doses; don’t double up.
Italy’s label: lymphocyte changes appear within 2 hours and can last up to 5 days after one IV dose, although the peptide itself is gone within minutes.
Label
After 3 weeks (rheumatoid arthritis)
In a 119-person placebo-controlled trial, 5 of 9 joint and symptom measures improved significantly; the gain faded over 4 weeks after stopping.
Trial
After 6 weeks (eczema)
In 100 patients, severity scores fell more than on placebo (p=0.04), with less itching and redness.
Trial
Over 48 weeks (HIV)
Among long-term AZT users, 2 on thymopentin vs 10 on placebo developed AIDS or died; among newer AZT users, 4 vs 0. CD4 counts didn’t differ.
Trial
Side effects and what to do
Injection-site pain, burning, itching or redness (Italian label: occasional)
Usually didn’t require stopping. Rotate sites; spreading redness, heat or pus needs a doctor.
Allergic reactions: itching, mild rash, flushing, swelling around the eyes (Italian label: rare)
Usually short-lived, settling alone or with antihistamines or steroids. Hives, face or throat swelling or trouble breathing needs emergency care.
Low white blood cell count (Italian label: rare)
The label advises periodic white cell counts and stopping if granulocytes fall.
Worse eczema, higher IgE and eosinophils in hyper-IgE syndrome (Italian label)
The label advises caution in this condition.
Myasthenia gravis: drooping eyelids, weak chewing or swallowing (one 2026 case report)
New muscle weakness after a course needs prompt medical care.
Stop and get medical help
Stop and get emergency care for hives, face or throat swelling or trouble breathing. Italy’s label advises stopping if granulocytes fall; new drooping eyelids, double vision or trouble swallowing need prompt care.
Can it cause …?
The side effects people ask about most, answered one by one. Each answer says where it comes from.
Dizziness
TrialNot in Italy’s label. A 2026 case report described brief dizziness at the start of each course in a woman who later developed myasthenia gravis.
Acne, rash or skin changes
LabelItaly’s label lists rare itching, mild rash and flushing of the face and chest, plus occasional injection-site redness and itching. It can worsen eczema in hyper-IgE syndrome.
Water retention or swelling
LabelSwelling around the eyes is listed as part of rare allergic reactions; fluid retention isn’t. Face or throat swelling needs urgent care.
Liver strain
Not reportedNot in Italy’s label, and liver harm wasn’t reported in controlled trials of over 1,000 people, including one in chronic hepatitis B.
Kidney problems
Not reportedNot in Italy’s label, and kidney harm wasn’t reported in controlled trials, including studies in people on dialysis.
Cancer risk
Not reportedNo cancer signal was reported in controlled trials of over 1,000 people, up to a year. It has been tested alongside cancer treatment.
TirednessHeadacheNausea or vomitingDiarrhea or constipationTrouble sleepingHair lossJoint or muscle painAnxiety, low mood or irritabilityLow or high blood sugarFast heartbeat or blood pressure changesMore hunger
Not reportedNot in Italy’s label, and not reported as a drug effect in controlled trials of over 1,000 people lasting up to a year.
Label: from the prescribing information. Trial: reported in human studies. Not reported: studied in people and not reported. A side effect that hasn’t been reported can still happen, especially with long or high-dose use. Any of these across every compound: the side-effect finder.
Who should avoid it
From its label, human studies and precautions based on how it works, most important first.
Allergy to thymopentin
LabelRuled out by Italy’s label. Rare allergic reactions (itching, rash, flushing, swelling around the eyes) usually settled with antihistamines or steroids.
Hyper-IgE syndrome
LabelItaly’s label urges caution: treatment can worsen eczema-like skin lesions and raise IgE antibodies and eosinophils, a type of white blood cell.
Low white blood cell counts
LabelThe label reports rare drops in white cells, advises periodic counts and suggests stopping if granulocytes, the main infection-fighting white cells, fall.
Pregnancy
LabelItaly’s label doesn’t recommend it because human data are insufficient; rat and rabbit studies showed no harm to fertility or the fetus.
People on immune-suppressing or immune-boosting drugs
LabelThe label advises caution when combining it with drugs that block or stimulate lymphocytes, the immune cells it acts on.
Myasthenia gravis or other autoimmune disease
PrecautionA 2026 case report linked repeated courses to new myasthenia gravis, an autoimmune nerve-muscle disease, in a 75-year-old woman. Italy’s label left autoimmune use to case-by-case judgment.
Interactions
Only interactions stated on a product label or measured in a human study are listed.
Drugs that suppress or stimulate the immune system (for example ciclosporin, high-dose corticosteroids, interferon)
LabelItaly’s label advises caution when they are given together, because thymopentin acts on lymphocytes; it doesn’t describe a measured effect.
Label: a product label rules it out, warns about it or lists the interaction. Precaution: follows from how it works or from a related drug, and hasn’t been tested. This isn’t a complete list: a pharmacist or doctor can check a specific medicine or condition. Every documented interaction, by medicine: drug interactions.
Special situations
What the label and studies say about pregnancy, breastfeeding, kidney and liver problems, age and surgery.
Pregnancy
LabelItaly’s label doesn’t recommend use in pregnancy because human data are insufficient; rat and rabbit studies showed no fertility harm or birth defects.
Breastfeeding
PrecautionNo data. Italy’s label doesn’t address breastfeeding, and it isn’t known whether it passes into milk.
Kidney problems
TrialThe label sets no dose change. Blood enzymes break it into ordinary amino acids, and it has been studied in people on dialysis for vaccine response and infection prevention.
Liver problems
LabelThe label gives no warning or dose change for liver disease.
Older adults
TrialNo separate label dose. In a 206-person trial around cancer surgery, it prevented the post-surgery drop in T cells and eased infection severity only in older patients.
Children and teens
LabelItaly’s former label covered inborn immune deficiencies, mostly in children, with doses by weight, and eczema trials included children. Vial Guide doesn’t show children’s doses.
Surgery and anesthesia
TrialGiven around major cancer surgery in a 206-person trial, it didn’t significantly cut infections (17.5% vs 24.3%). The label lists no anesthesia interactions; tell the surgical team about it.
Label: what the prescribing information says. Trial: from human studies. Precaution: not studied, so the caution follows from how it works or from a related drug. Ages are given as approved or studied; this site never gives doses for children. Across every compound: pregnancy, breastfeeding, kidney disease, liver disease, older adults and surgery.
Tracking and pairing
Worth tracking
White blood cell and neutrophil counts (Italian label)
Signs of allergic reaction
Often paired with
Usually run on its own.
Human studies
5 key published human studies, with how many people took part. Animal studies aren’t listed here.
1995352 people
AIDS or death: 2 vs 10 on placebo in long-term AZT users (p=0.024) but 4 vs 0 in newer users; CD4 counts and side effects didn’t differ.
Design
Randomized double-blind placebo-controlled trial, asymptomatic HIV infection on AZT
Registered trials that are still running, or that finished without published results, most important first. Checked on ClinicalTrials.gov, October 7, 2026.
Phase 2NCT06112041
PRaG 9.0: radiotherapy, a PD-L1 antibody, GM-CSF and thymopentin in older adults with advanced solid tumors (China)
Listed as not yet recruiting; estimated completion October 2026
Phase 1NCT05978908
FC-12738, a reversed-sequence analog of thymopentin, in healthy adults and people with ALS
Approval rested on 1980s–90s trials, mostly small and short and many run with the developers; results were mixed, positive in some rheumatoid arthritis and eczema trials but negative in chronic hepatitis B, infection after surgery and a Belgian arthritis series. The largest trial, 352 people with HIV, helped only one subgroup. Recent evidence is mostly small Chinese studies, often unblinded. Safety beyond a year is unstudied.
How it’s supplied
Chinese injections, as solutions or powder vials, commonly 1 mg or 10 mg. Italy’s former Sintomodulina came as 50 mg/1 mL ampoules and 10 mg/mL multidose vials. Injected under the skin or into a muscle, 3× a week or every other day in courses; Italy’s label also allowed slow IV injection for autoimmune disease. It’s used as supplied, so the calculator and dose log don’t apply.
The Italian ampoules and multidose vials came ready to inject. Chinese powder vials are dissolved before injection. Laboratory-grade powder is sold for research, but no research vial size is common.
Datasheet
Half-life
about 30 secondsLabelIn human plasma, where blood enzymes split it into its amino acids; its effects on lymphocytes last days.
Type
Peptide, 5 amino acids
Molecular weight
679.8 g/mol
Formula
C30H49N9O9
Sequence
RKDVY
Storage before use
2–8 °C (Italian ampoules and multidose vials); shelf life 2 years.
After mixing or opening
The Italian label gives no in-use period for an opened multidose vial.
Half-life: Sintomodulina Italian label, section 5.2; Tischio et al., Int J Pept Protein Res 1979, PMID 395119
Molecule: PubChem CID 451417; FDA UNII O3Y80ZF13F; CAS 69558-55-0 (free peptide). The monoacetate salt is UNII 1938Y8P51M, CAS 89318-88-7.
Storage:Label Sintomodulina Italian label, sections 6.3–6.4 (revised November 1, 2004)
A five-amino-acid peptide, often supplied as its acetate salt, so powder weight slightly overstates peptide content. Splenopentin (SP-5) differs by one amino acid; thymosin alpha-1 and thymalin are different thymus products.
Cautions
Italy’s label reports rare drops in white blood cells: counts were to be checked, and treatment stopped if granulocytes fell.
Rare allergic reactions (itching, rash, flushing, swelling around the eyes) and injection-site pain or redness (Italian label).
It can worsen eczema and raise IgE in hyper-IgE syndrome (Italian label).
A 2026 case report linked repeated courses to new myasthenia gravis in a 75-year-old woman.
Controlled trials gave mixed results; it isn’t approved in the US or EU.
Questions
What is thymopentin?
A synthetic five-amino-acid peptide (Arg-Lys-Asp-Val-Tyr) that copies the active part of thymopoietin, a thymus hormone that helps immature T cells mature. It is injected to support weakened immunity.
How does thymopentin work?
Thymopentin copies amino acids 32–36 of thymopoietin, a 49-amino-acid thymus hormone that helps immature T cells mature. Italy’s label says it drives the maturation of T-cell precursors through cyclic AMP, a chemical messenger inside cells, and regulates mature lymphocytes through cyclic GMP. Blood enzymes break it down within about 30 seconds, yet lymphocyte changes appear within 2 hours and can last 5 days after one IV dose. Its receptor isn’t settled: lab studies point to thymopoietin receptors on T-cell lines and to TLR2, an immune sensor. Why such a brief exposure has lasting effects, and why trials disagree, is unexplained.
Is thymopentin FDA-approved?
Not approved in the US or EU; FDA granted an orphan designation for sarcoidosis in 2011, with no approval. Registered in China; formerly approved in Italy as Timunox and Sintomodulina, neither of which is on Italy’s or the EU’s medicines registers now. Never nominated for US compounding: it isn’t on FDA’s 503A or 503B bulk lists or their Category 1, 2 or 3 lists (503A categories updated May 14, 2026).
What is the usual thymopentin dose?
From the label (Sintomodulina, Italian): 50 mg under the skin 3× a week for 3–6 weeks, for weakened immunity, side effects of chemotherapy or radiation, or alongside vaccines; the same dose by slow IV injection in autoimmune disease. From human studies (Goldstein 1995): 50 mg under the skin 3× a week for 48 weeks in 352 adults with HIV taking AZT. These are the amounts sources reference, not recommendations.
How is thymopentin given?
Injected under the skin or into a muscle, 3× a week or every other day in courses; Italy’s label also allowed slow IV injection for autoimmune disease.
Who should avoid thymopentin?
Allergy to thymopentin: Ruled out by Italy’s label. Rare allergic reactions (itching, rash, flushing, swelling around the eyes) usually settled with antihistamines or steroids. Hyper-IgE syndrome: Italy’s label urges caution: treatment can worsen eczema-like skin lesions and raise IgE antibodies and eosinophils, a type of white blood cell. Low white blood cell counts: The label reports rare drops in white cells, advises periodic counts and suggests stopping if granulocytes, the main infection-fighting white cells, fall. The “Who should avoid it” section lists 3 more groups and one interaction.
What is the half-life of thymopentin?
About 30 seconds, according to the prescribing information. In human plasma, where blood enzymes split it into its amino acids; its effects on lymphocytes last days.
How should thymopentin be stored?
Before mixing: 2–8 °C (Italian ampoules and multidose vials); shelf life 2 years. The Italian label gives no in-use period for an opened multidose vial.
Is thymopentin banned in sport?
No. Not named on the 2026 list. S0 doesn’t apply because it’s a registered medicine in China, and it isn’t a hormone or growth factor covered by S2. WADA’s 2027 list doesn’t change this.
Has thymopentin been studied in people?
Yes. The human studies section lists 5 published studies. The largest, from 1995, included 352 people. AIDS or death: 2 vs 10 on placebo in long-term AZT users (p=0.024) but 4 vs 0 in newer users; CD4 counts and side effects didn’t differ.
How long has thymopentin been studied in people?
Trial Up to 52 weeks: 46 people with HIV in a placebo-controlled trial. The largest trial treated 352 people for 48 weeks.
Does thymopentin come in other forms, like a pill or nasal spray?
Trial Labels use injection under the skin, into a muscle or slowly into a vein. Trials also injected it around painful shoulders or knees and melanoma skin metastases. No oral product exists.
Can you drink alcohol while taking thymopentin?
No study No data. Italy’s label doesn’t mention alcohol.
Can thymopentin be taken with semaglutide or tirzepatide?
No study No study has combined them. Italy’s label lists no interaction with diabetes or weight-loss drugs.
What happens if you take too much thymopentin?
Label Italy’s label reports no overdose cases; mice tolerated very large doses. Call Poison Help (1-800-222-1222), or emergency services for severe symptoms.
Sources
Sintomodulina (thymopentin) 50 mg/mL injection, Italian summary of product characteristics (Italfarmaco; authorization dated June 1, 2000; text revised November 1, 2004)
Goldstein et al., a synthetic pentapeptide with the activity of thymopoietin (Science 1979) PMID 451537
Goldstein et al., thymopentin in AZT-treated asymptomatic HIV infection, double-blind placebo-controlled trial (J Acquir Immune Defic Syndr Hum Retrovirol 1995) PMID 7859140
Lemmel et al., thymopentin in rheumatoid arthritis, multicenter placebo-controlled study of 119 patients (Dtsch Med Wochenschr 1988, in German) PMID 3276492
Leung et al., thymopentin in atopic dermatitis, double-blind placebo-controlled trial (J Allergy Clin Immunol 1990) PMID 2185294
Chen et al., thymopentin for infection prevention in peritoneal dialysis, retrospective study (BMC Nephrol 2025) PMID 41023915
National Health Commission of China, notice on the first national list of drugs under key monitoring for rational use, including thymopentin (June 11, 2019)
For the protocol details
Zhao et al., thymopentin-induced myasthenia gravis, case report (Balkan Med J 2026) PMID 41504129
For how it works, who should avoid it and the limits of the evidence
Sintomodulina (thymopentin) injection, Italian summary of product characteristics: mechanism, pharmacokinetics, contraindications, warnings, interactions, pregnancy (text revised November 1, 2004)
Heavner et al., thymopentin analogs and thymopoietin receptors on two human T-cell lines (Regul Pept 1990) PMID 2158125
Li et al., a thymosin alpha-1–thymopentin fusion peptide and binding to TLR2 (Cancer Lett 2013) PMID 23684552
Gonser et al., thymopentin, an immune modulator with unknown mode of action (Pharm Acta Helv 1999) PMID 10443171
Veys et al., thymopentin in rheumatoid arthritis, three trials without significant benefit (J Rheumatol 1984) PMID 6384507
For uses, the side-effect questions, special situations, trials, identifiers and status outside the US
Sintomodulina (thymopentin) injection, Italian summary of product characteristics: indications, posology, warnings, side effects, pregnancy, overdose (text revised November 1, 2004)
Aiuti et al., thymopentin in 26 patients with primary immunodeficiencies (Lancet 1983) PMID 6131256
Conant et al., thymopentin in asymptomatic HIV infection, double-blind placebo-controlled study (AIDS 1992) PMID 1361746
Bolla et al., thymopentin to prevent relapses of herpes labialis, placebo-controlled trial (Surv Immunol Res 1985) PMID 3898291
Gebbia et al., thymopentin vs G-CSF to prevent febrile low white cell counts during chemotherapy (Anticancer Res 1994) PMID 7516641
Fabrizi et al., meta-analysis of thymopentin with hepatitis B vaccine in dialysis patients (Aliment Pharmacol Ther 2006) PMID 16696803
Malaise et al., thymopentin in active rheumatoid arthritis, placebo-controlled trial (Surv Immunol Res 1985) PMID 3898298
Kantharia et al., thymopentin in rheumatoid arthritis, multicenter randomized trial (Br J Rheumatol 1989) PMID 2650797
Stiller et al., thymopentin as add-on treatment in atopic dermatitis, placebo-controlled trial (J Am Acad Dermatol 1994) PMID 8157786
Fattovich et al., thymopentin in chronic hepatitis B, randomized controlled trial (J Hepatol 1994) PMID 7836705
Braga et al., thymopentin and infection after cancer surgery, randomized controlled trial (Br J Surg 1994) PMID 8156337
Pipino and Vittore, local thymopentin injections for shoulder, tendon and knee pain vs methylprednisolone (Arzneimittelforschung 1988) PMID 3284530
Cascinelli et al., thymopentin injected around melanoma skin metastases, placebo-controlled (Melanoma Res 1993) PMID 8161886
Liu et al., thymopentin breakdown in the gut and nanocarriers for oral forms (Int J Pharm 2022) PMID 35995317
FDA GSRS records (UNII O3Y80ZF13F and 1938Y8P51M); PubChem CID 451417; EMA Article 57 product data and AIFA medicines database searches; ClinicalTrials.gov and Health Canada Drug Product Database searches (October 9, 2026); Australian Poisons Standard, June 2026