Prostatilen
A prostate-gland peptide extract used in Russia for prostatitis and an enlarged prostate, backed by small, mostly uncontrolled studies
Prostatilen is a mixture of peptides extracted from cattle prostate glands, first reported in Soviet journals in 1991 by the research school of Vladimir Khavinson, which calls such tissue extracts bioregulators. It has been given by injection and as rectal suppositories to men with chronic prostatitis and benign prostatic enlargement, and the Russian-language reports describe less pain, better urine flow and less residual urine. Almost none of those studies had a placebo group, most are short reports with few numbers, and the extract has no FDA or EMA approval.
Used in human trials: 5-10 mg, Once daily, Intramuscular (Study: chronic prostatitis, 307 men) Details ↓
Recommended Dosing
Used in human trials
No manufacturer dose exists for this use: these are amounts given in published trials, not recommendations.
Work out syringe units → · New to syringes? · All dosing data ↓
What is it?
Prostatilen is what you get when cattle prostate glands are processed and the small proteins and peptides are kept. It comes from the same research school as thymalin and epithalamin, the group around Vladimir Khavinson that calls organ extracts of this kind peptide bioregulators and proposes that each one restores the function of the organ it came from. Khavinson co-authored the first clinical reports in 1991, and his group's 2013 review lists Prostatilen among the bioregulators they have studied in people. Like the other preparations from this school, its literature is one research network, small studies and Russian-language journals.
The early trials gave it by intramuscular injection. A 1991 report on 307 men with chronic prostatitis used 5 to 10 mg once a day for 5 to 10 days and says symptoms disappeared or eased in 96.7%, often after two or three injections. Another 1991 trial in 37 men with chronic prostatitis and 15 with prostatic adenoma reported less pain and fewer urinary symptoms, better urine flow, less residual urine and fewer white cells in prostate fluid. A 2003 summary describes use in 1,115 patients with prostatitis and kidney infection. None of these abstracts mentions a control group, and they report no adverse effects.
Later work moved to rectal suppositories. A Saint Petersburg university clinic reviewed 96 men aged 51 to 89 with benign prostatic hyperplasia and found that suppositories containing 30 mg with dimethyl sulfoxide eased the symptoms of urinary obstruction; a 2006 study repeated 15-suppository courses every three months and reported less residual urine. According to a 2022 trial report, the registered suppository contains 3 mg. In two randomised but open-label trials it served as the comparison drug: in 2022 against Prostatilen AC, the same suppository with zinc added, in 98 men with poor semen quality, and in 2026 against another prostate extract in 60 men with chronic prostatitis. In both, the newer product did better.
The authors also looked for how it might work. In men with prostatitis they report normalised blood clotting measures and increased clot breakdown, shifts in immune-cell counts and a fall in lactoferrin, a marker of prostate inflammation, in semen. In rats it prevented drug-induced enlargement of the prostate and the oxidative damage that came with it, stimulated sperm production in a model of infertility, and in isolated tissue increased the contraction of bladder and lymphatic smooth muscle. After anorectal surgery, an injection of 5 mg was followed within 40 minutes by the return of urination in men with acute urinary retention.
One result deserves attention. In mice, injected Prostatilen at 5 micrograms and above increased chromosome breaks in bone marrow and abnormal sperm heads, a sign of damage to genetic material, in two studies from the early 1990s; adding vitamin C or binding the extract to a polymer reduced the effect. No later study checked whether this matters in people. Taken together, the evidence shows a widely used Russian preparation whose benefits have not been tested against placebo or repeated outside its home network. It is not approved in the US or the EU.
Mechanism of Action
A mixture of prostate peptides has no single target. The studies below describe effects on inflammation, blood clotting, immunity and smooth muscle; none isolates the molecule responsible.
Blood clotting
In 34 men with chronic prostatitis it normalised platelet and vessel-wall clotting measures and increased fibrinolysis; in rats a single dose did nothing, while 5- and 10-day courses did (1997 study).
Immune measures
In 46 patients with chronic kidney infection, T-cell counts and function rose and markers of inflammation such as fibrinogen and the red-cell sedimentation rate fell after a 5-day course (1997 study).
Oxidative balance in the prostate
In rats with drug-induced prostatic hyperplasia it prevented the enlargement and normalised lipid peroxidation products in the gland (2005 and 2006 studies).
Smooth muscle
It increased the contraction of bladder muscle in rats and of human bladder muscle in surgical patients (1999 study), and of rat lymphatic vessels at 2 and 5 micrograms per ml (2025 study).
Published Research
These are the studies of Prostatilen read from their PubMed abstracts on October 29, 2026: fourteen in patients, six in animals and one review by its developers. All are Russian or Ukrainian, most are short reports in Russian-language urology journals, and only the two most recent trials describe randomisation, against other products rather than placebo. Several titles do not name Prostatilen; they are carded because their abstracts name it as the preparation given.
307 men with chronic prostatitis
Men aged 18 to 74, ill for between four months and 36 years, received 5-10 mg into the muscle once a day for 5-10 days. Symptoms disappeared or eased in 96.7%, the effect starting after two or three injections, with follow-up at four to six months. The authors report no side effects; no control group is described.
Prostatitis and adenoma: 52 men
In 37 men with chronic prostatitis and 15 with prostatic adenoma, pain and urinary symptoms eased, urine flow improved, and residual urine and white cells in prostatic fluid fell. The authors also report better sexual function and sperm production, and no adverse reactions.
Prostatitis with sexual dysfunction
A clinical report on the drug obtained from cattle prostate describes anti-inflammatory, antibacterial and immune-modulating effects and better urination and sexual function in men with prostatitis, and recommends it for production. The abstract gives no patient numbers.
A non-antibiotic approach to prostatitis
In chronic prostatitis, Prostatilen reduced patients' complaints and the white-cell reaction in prostate secretions and is said to have normalised immune status and lowered bacterial counts. The authors propose it as basic treatment, with antibiotics only during flare-ups.
Clotting in prostatitis: 34 men and rats
In 34 men with chronic prostatitis it normalised platelet and vessel-wall clotting and activated clot breakdown, with smaller effects on coagulation itself. In 360 rats, 5- and 10-day courses reversed the clotting changes of experimental prostatitis, but a single dose did not.
Chronic kidney infection: 46 patients
Patients with chronic pyelonephritis in a quiet phase received 5 mg a day into the muscle for 5 days. Symptoms eased; white cells and bacteria in urine, the red-cell sedimentation rate, fibrinogen and ceruloplasmin fell; clotting tendency fell and T-cell numbers and function rose.
Semen markers in 174 men
Men with chronic prostatitis, some with epididymitis, had higher lactoferrin in semen than 22 healthy men before treatment. After Prostatilen, lactoferrin fell close to the healthy level; the authors use it mainly to show lactoferrin as a marker of prostatitis.
Urinary retention after anorectal surgery
In 87 patients aged 23 to 78 after haemorrhoid or sphincter operations, urination returned within 40 minutes of a 5 mg injection. Of 23 given it before any urge to urinate, 14 had a smooth recovery and 9 needed one more injection. It was well tolerated.
Bladder muscle in surgical patients
In rat bladder strips and cat kidney vessels Prostatilen made smooth muscle contract, and it raised the contractile activity of human bladder muscle. Clinical cases after rectal sphincter operations and in chronic prostatitis are reported as restoring bladder function.
1,115 patients in urology
A summary of use in 1,115 patients with chronic pyelonephritis and prostatitis reports corrected clotting and immune disorders, better microcirculation and less inflammation in kidney and prostate. The authors propose it as basic therapy for chronic prostatitis; no comparison group is described.
96 men with prostatic hyperplasia
A Saint Petersburg university clinic reviewed men aged 51 to 89 with benign prostatic hyperplasia and found Prostatilen relieved obstruction symptoms in those with early or moderate disease. The authors prefer suppositories containing 30 mg with dimethyl sulfoxide.
Repeated suppository courses for adenoma
Men with early prostatic adenoma had courses of 15 suppositories, each with 30 mg Prostatilen and 90 mg dimethyl sulfoxide, every three months. Symptoms of outflow obstruction and residual urine fell; the authors suggest it as a cheap option alone or with standard drugs.
Comparator in a semen-quality trial
In an open-label, randomised phase 3 trial of 98 men aged 25 to 45 with chronic prostatitis and poor semen, 49 received standard Prostatilen suppositories and 49 the zinc-containing Prostatilen AC, once daily for 10 days. Motile sperm rose 4.1% on Prostatilen and 14.3% on Prostatilen AC, and the zinc version did significantly better on normal forms.
Comparator against another prostate extract
Sixty men aged 37 to 57 with chronic non-bacterial prostatitis were randomised, without blinding, to Prostatex Plus 10 mg or Prostatilen 3 mg as nightly suppositories for 20 days alongside other treatment. Symptoms, urine flow and prostate fluid improved in both groups, more with Prostatex Plus.
Drug-induced prostatic hyperplasia in rats
Thirty days of sulpiride enlarged the lateral prostate lobes of rats and raised oxidation products. Prostatilen prevented the enlargement and normalised the oxidant-antioxidant balance in the gland, though not total antioxidant activity in blood.
Compared with saw palmetto extract in rats
In rats with hyperplasia caused by high prolactin, both Prostatilen (1 mg of peptides per kg) and a saw palmetto extract prevented the increase in prostate mass and volume. Only Prostatilen brought lipid hydroperoxides back down and restored glutathione peroxidase activity.
Male infertility model in rats
In male rats used as a model of infertility, Prostatilen and testilin, a testis extract, stimulated sperm production and the hormone function of the testes, and the authors propose both for clinical use in infertility.
Genetic damage in mice
Injected into male mice at 5, 10 and 50 micrograms, Prostatilen increased both abnormal sperm heads and chromosome aberrations in bone marrow cells. Vitamin C given with it lowered the sperm-head anomalies at every dose combination.
Rats exposed to g-forces
In 37 rats spun on a centrifuge, Prostatilen given beforehand moderated stress behaviour and the changes in prostate, testis and kidney tissue that the g-forces caused, and sperm production looked normal.
Rat lymphatic vessels
In isolated rat lymphatic vessels, Prostatilen at 2 and 5 micrograms per ml raised the frequency of contractions by 23.7% and 37.6%, while two other prostate extract substances had no effect or slowed them.
The developers' review of their clinical studies
Khavinson and colleagues summarise their long-term clinical studies of peptide bioregulators, including thymalin, epithalamin and Prostatilen, for preventing disease and treating people of different ages, and argue for their use as geroprotectors.
Dosing Data
Prostatilen is not approved in the US or the EU, and no Russian product label was read for this page. The rows below are the amounts stated in the abstracts of published human studies; none comes from a dose-finding trial.
Educational information, not medical advice. Each dose above is tagged with its source: an approved label, a published human study, animal data, or amounts reported by users. None is a recommendation for you. An unapproved compound has no established safe or effective human dose, and products sold for “research use only” are not made or tested for people. Talk to a doctor before acting on anything on this site, including before you start, stop or change any medicine or dose. Full medical disclaimer.
What a Buyer Needs to Know
What is sold, how it is mixed, stored and taken, and what is known about its safety, quality and legal status. Each part names its source. Where we have none, it says unknown.
What is sold
Unknown: we hold no label and no published test that says what forms or vial sizes Prostatilen is sold in. A vial's own label is a seller's claim, not a source.
Mixing a vial: a worked example
An arithmetic example, not a recommendation: a 10 mg vial mixed with 3 mL of bacteriostatic water holds 3,333.3 mcg per mL, so 5 mg, the first amount in the “Study: chronic prostatitis, 307 men” row (5-10 mg) would be 150.0 units, more than a 1 mL U-100 syringe holds. Put your own vial's numbers into the reconstitution calculator.
Source: dose: Used in human trials, PMID 1823682 (Dosing Data below); vial and water: the calculator's default example, not a vial size we have a source for.
Storage before and after mixing
Unknown: no label or published stability study on file says how to store Prostatilen, before or after mixing. The mixing guide sets out the general rules, with their sources: keep a mixed vial in the fridge, and use it promptly, as the bacteriostatic water label says of any drug dissolved in it. The 28 days often quoted is the limit for an opened multiple-dose vial from a manufacturer, an outer limit set for sterility, not a time a mixed solution has been shown to keep. Nobody has published how long Prostatilen stays intact once mixed.
How it is taken
As it was given in human studies: Intramuscular (Once daily; Study: chronic prostatitis, 307 men); Rectal (15 suppositories per course; Study: prostatic adenoma, repeated courses).
For injection technique, sites and needle disposal, see the mixing guide.
Source: Used in human trials: the route and frequency of each row in Dosing Data below.
What to expect, and when
How long it stays in the body: not established by a measurement cited on this entry.
How long the doses were given: Study: chronic prostatitis, 307 men: 5-10 days; Study: chronic pyelonephritis, 46 patients: 5 days; Study: prostatic adenoma, repeated courses: A course every 3 months.
When effects appear: unknown; no source on this page gives a time to effect for Prostatilen. Results reported in the studies are under Published Research.
Source: Used in human trials, the duration of each row in Dosing Data below.
Side effects, and when to stop or get help
From the Side Effects section: The early trials report no side effects or adverse reactions, without describing how they were looked for; In mice, injected Prostatilen increased chromosome aberrations and abnormal sperm heads at 5 micrograms and above (PMID 8370509); The two randomised trials compared it with other products, not placebo, and report no safety numbers in their abstracts. Full list and cautions ↓
When to stop or get help: unknown; no label or trial on file sets rules for stopping Prostatilen. Treat a severe or unexpected reaction as a reason to stop and see a doctor.
Source: the Side Effects section below (“From the abstracts read, which say little about safety”).
Interactions
Unknown: a PubMed search for human interaction studies of Prostatilen (reviewed 2026-10-28) found none. Unknown is not the same as safe to combine.
Every peptide's record, with its source: the interaction matrix.
Checking what you bought
Unknown: no published independent test of Prostatilen products is in our lab-results database yet, so how products sold under this name measure up is not known.
To read a certificate of analysis, paste it into the COA decoder. Trust & Verification explains what independent testing can and cannot show.
Legal status
US: Not FDA Approved (Not FDA- or EMA-approved: Drugs@FDA and the EMA medicines list hold no record (searched October 28, 2026)). Sport: Unsettled (S0 may apply).
Country by country ↓ · Regulatory tracker
Source: this entry's approval status and the WADA Prohibited List, as in Legal Status below.
Side Effects & Contraindications
Reported Side Effects
From the abstracts read, which say little about safety.
Contraindications & Cautions
No product label was read for this page. These cautions follow from the evidence.
Legal Status
Prostatilen is used in Russia and is not approved in the US or the EU.
Frequently Asked Questions
?What is Prostatilen?
A mixture of peptides extracted from cattle prostate glands, from Vladimir Khavinson's research school, used in Russia for chronic prostatitis and benign prostatic enlargement.
?Does Prostatilen work?
Russian studies from 1991 onwards report fewer symptoms and better urine flow, but they are small, mostly uncontrolled, and none compared it with placebo. In the two randomised trials it was the comparison drug, and the newer products did better.
?How was it given in studies?
As intramuscular injections of 5-10 mg a day for 5-10 days in the early trials, and later as rectal suppositories of 3 mg, or 30 mg with dimethyl sulfoxide, in courses lasting 10 to 20 days.
?Is Prostatilen safe?
The clinical reports describe no side effects, but they did not systematically measure safety. Mouse studies from the 1990s found genetic damage in sperm and bone marrow cells at injected doses, which has not been followed up in people.
?Is it the same as Prostamax?
No. Prostamax is a short synthetic peptide from the same research school; Prostatilen is the natural extract, a mixture. Each has its own entry on this site.
References
- [clinical-trial] Tkachuk VN, et al. "[The use of prostatilen in treating patients with chronic prostatitis]." Urol Nefrol (Mosk), 1991:40-3. PMID: 1823682.
- [clinical-trial] Vozianov AF, et al. "[The use of prostatilen in treating patients with prostatic diseases]." Urol Nefrol (Mosk), 1991:43-6. PMID: 1823683.
- [pubmed] Gorpinchenko II, et al. "[The treatment with the polypeptide preparation "Prostatilen" of patients with prostatitis complicated by a sexual functional disorder]." Vrach Delo, 1991:48-51. PMID: 2058122.
- [pubmed] Boĭko MI. "[A new method for treating patients with chronic prostatitis]." Lik Sprava, 1995:65-7. PMID: 7483550.
- [pubmed] al-Shukri SKh, et al. "[The effect of prostatilen on the hemostatic indices in chronic prostatitis (a clinical and experimental study)]." Urol Nefrol (Mosk), 1997:38-41. PMID: 9245057.
- [pubmed] al-Shukri SKh, et al. "[The bioregulatory therapy of patients with chronic pyelonephritis]." Urol Nefrol (Mosk), 1997:6-8. PMID: 9381626.
- [pubmed] Gal'kovich KR, et al. "[The immunochemical determination of the concentration of organ-specific ejaculate proteins in the differential diagnosis of chronic inflammatory diseases of the male reproductive system]." Urol Nefrol (Mosk), 1997:40-2. PMID: 9412014.
- [pubmed] Iaitskiĭ NA, et al. "[The treatment of acute reflex urinary retention after operations in the area of the rectal sphincter]." Vestn Khir Im I I Grek, 1996;155(6):80-1. PMID: 9163164.
- [pubmed] Al'-Shukri SKh, et al. "[Influence of prostatilen on smooth muscle organs functional activity in surgical patients (clinical and experimental study)]." Khirurgiia (Mosk), 1999:47-9. PMID: 10050514.
- [pubmed] Al'-Shukri SKh, et al. "[Our experience in the use of prostatilen in urology]." Urologiia, 2003:32-6. PMID: 14708243.
- [pubmed] Al'-Shukri SKh, et al. "[Prostatilen effects on voiding disorders in patients with benign prostatic hyperplasia]." Urologiia, 2005:25-6. PMID: 16281835.
- [clinical-trial] Al'-Shukri SKh, et al. "[Prostatilen treatment of prostatic adenoma]." Urologiia, 2006:22, 25-6. PMID: 17315707.
- [clinical-trial] Rybalov M, et al. "INFLUENCE OF ADDING ZINC ARGINYLE-GLYCINATE TO IMPROVE EFFICACY OF BIOREGULATORY PEPTIDES OF THE PROSTATE GLAND IN TREATMENT OF PATIENTS WITH IMPAIRED SPERM PARAMETERS." Georgian Med News, 2022:108-114. PMID: 36318852.
- [clinical-trial] Maslyukov A V, et al. "[The effectiveness of Prostatex Plus in the treatment of patients with chronic abacterial prostatitis cate- gories III B]." Urologiia, 2026:99-105. PMID: 42417304.
- [pubmed] Belostotskaya LI, et al. "Prooxidant-antioxidant balance in the prostate and blood of rats with sulpyride[corrected]-induced prostatic hyperplasia corrected with prostatilen." Bull Exp Biol Med, 2005;139(3):334-6. PMID: 16027846.
- [pubmed] Belostotskaia LI, et al. "[Effect of biologically active substances of animal and plant origin on prooxidant-antioxidant balance in rats with experimental prostatic hyperplasia]." Eksp Klin Farmakol, 2006;69(4):66-8. PMID: 16995443.
- [pubmed] Boĭko MI. "[The validation of the use of prostatilen and testilin for treating male infertility]." Lik Sprava, 1995:113-7. PMID: 8630775.
- [pubmed] Bolonina VP, et al. "[Effect of vitamin C on prostatilen mutagenicity in mice]." Genetika, 1993;29(7):1095-8. PMID: 8370509.
- [pubmed] Novikov VS, et al. "[Prophylactic use of prostatilen in rats prior to exposure to +Gz loads as a way of reducing changes in urogenital organs]." Aviakosm Ekolog Med, 1997;31(2):25-7. PMID: 9190250.
- [pubmed] Nechaykina OV, et al. "Comparative Assessment of the Influence of Active Pharmacological Substances of Prostate Extract on the Contractile Activity of Rat Lymphatic Vessels." Bull Exp Biol Med, 2025;179(6):718-721. PMID: 41514109.
- [review] Khavinson VKh, et al. "[Peptide bioregulators: the new class of geroprotectors. Message 2. Clinical studies results]." Adv Gerontol, 2013;26(1):20-37. PMID: 24003726.
- [pubmed] Borovets S Y, et al. "[Effect of prostate-derived complex peptide preparations on erectile function in patients with chronic prostatitis]." Urologiia, 2026:92-98. PMID: 42417303.
Sources & Citations
Every study on this page was read from its PubMed record on October 29, 2026; most are Russian-language papers with short English abstracts. A study of Prostatilen AC, the version with added zinc, is listed under References with a reason. Regulatory status comes from Drugs@FDA and the EMA medicines list, searched October 28, 2026. Grey Peptides sells nothing and links to no vendor.
Medical Disclaimer: This content is for educational and informational purposes only. It is not medical advice, and nothing here is an instruction to obtain or use any compound. Talk to a licensed clinician about your own situation.