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Regulator: Ministry of Health, Labour and Welfare (MHLW), with the Pharmaceuticals and Medical Devices Agency (PMDA) doing the scientific review and safety monitoring

GLP-1 drugs and peptides in Japan

In Japan, the health ministry (MHLW) decides which medicines can be sold, and an agency called PMDA reviews them first. Semaglutide (Wegovy) and tirzepatide (Zepbound) are approved for obesity, but only for people who also have a related health problem, and doctors are asked to follow a strict national guideline. Peptides sold online, such as BPC-157, are not approved medicines in Japan, and it is illegal to sell or advertise them as medicines.

Last verified 2026-09-29 · how we verify

Official regulator site

GLP-1 medicines

Approved by MHLW (dates from PMDA lists): Mounjaro (tirzepatide, type 2 diabetes, 26 September 2022); Zepbound (tirzepatide, obesity, 27 December 2024, with moderate-or-worse obstructive sleep apnoea added on 18 May 2026); Wegovy (semaglutide, obesity, 27 March 2023, with metabolic dysfunction-associated steatohepatitis with moderate or advanced fibrosis added on 19 June 2026); Ozempic (semaglutide, type 2 diabetes, 23 March 2018); Rybelsus (oral semaglutide, type 2 diabetes, 29 June 2020); Kyinsu (insulin icodec with semaglutide, type 2 diabetes, 19 February 2026); Victoza (liraglutide, type 2 diabetes, 20 January 2010) and Xultophy (insulin degludec with liraglutide, 18 June 2019); Trulicity (dulaglutide, type 2 diabetes, 3 July 2015). Byetta (exenatide, 2010) and Bydureon (2012) were approved but exenatide is absent from the March and August 2026 NHI price lists and the PMDA database holds only review reports for it. Wegovy's obesity indication is limited to people with hypertension, dyslipidaemia or type 2 diabetes who did not respond enough to diet and exercise and who have a BMI of 35 or more, or a BMI of 27 or more with at least two obesity-related health conditions. On 18 May 2026 Zepbound's obesity wording was changed to cover hypertension, dyslipidaemia or impaired glucose metabolism (type 2 diabetes, impaired glucose tolerance and similar), with the same BMI criteria; the tirzepatide guideline revised in May 2026 still asks that patients have a diagnosis of hypertension, dyslipidaemia or type 2 diabetes. The Optimal Use Promotion Guidelines (semaglutide first issued November 2023, revised June 2026; tirzepatide March 2025, revised May 2026) say the drugs must not be used for slimming or dieting, must be used at insured medical institutions with an approved specialist and a full-time registered dietitian, only after at least six months of supervised diet and exercise with dietitian advice at least every two months, and for at most 68 weeks (semaglutide) or 72 weeks (tirzepatide) in a course. The MHLW notice of 16 June 2026 says the safety and efficacy of these drugs have not been confirmed when they are used outside the approved indication and dosing, such as for cosmetic or slimming purposes. Rhythm Pharmaceuticals' setmelanotide (Imcivree) was approved on 24 August 2026 for acquired hypothalamic obesity and is not yet on the price list. Orforglipron and the other incretin candidates have no approval in the PMDA lists to September 2026; we did not verify any pending application.

Peptides

No peptide sold online as a wellness or research product (BPC-157, TB-500, GHK-Cu, KPV, MOTS-c, Semax, Selank, Epitalon, ipamorelin, CJC-1295, sermorelin, AOD-9604, melanotan II, kisspeptin, DSIP, LL-37) appears in PMDA's approved-drug lists or its package-insert database, so none is an approved medicine in Japan. Marketing a drug needs approval under PMD Act Art. 14; selling one marketed without it is prohibited (Art. 55(2)) and carries penalties of up to three years' imprisonment or JPY 3 million (Art. 84). Advertising the name, effect or method of manufacture of an unapproved drug is banned for anyone (Art. 68). We found no MHLW or PMDA public notice naming these peptides, so no molecule is marked as specifically banned. Individuals may import a prescription drug for their own use up to one month's supply, may not resell or share it, and imported drugs are outside the adverse drug reaction relief system; physicians may import an unapproved drug for a patient under their own responsibility. Under the Pharmacists Act a pharmacist dispenses only on a prescription and may not change the prescribed drug without the prescriber's consent; we found no Japanese rule permitting a pharmacy to compound an unapproved peptide as a marketed product. In sport, the WADA Prohibited List 2026, which Japan's national anti-doping agency applies, names BPC-157 under S0 (non-approved substances), TB-500 and thymosin beta-4 under S2 (growth factors), CJC-1295, sermorelin, tesamorelin and ipamorelin under S2 (growth hormone releasing factors), AOD-9604 under S2 (growth hormone fragments), kisspeptin under S2 (testosterone-stimulating peptides in males) and MOTS-c under S4 (metabolic modulators). No 2026 MHLW or PMDA action naming BPC-157 or a similar peptide was found.

Advertising rules

Japan does not allow prescription medicines to be advertised to the public: the Standards for Fair Advertising Practices concerning Medicinal Products (notice of 29 September 2017) bar advertising drugs supplied on a doctor's prescription to anyone other than medical professionals. PMD Act Art. 66 bans false or exaggerated claims about any drug and lets MHLW order a surcharge of 4.5 percent of the sales of the products concerned (Art. 75-5-2); Art. 68 bans advertising the name, manufacture, effect or performance of a drug that has not yet been approved. Clinics fall under the Medical Care Act and the Medical Advertising Guidelines (last revised 30 March 2026): advertising is limited to a listed set of items, treatment with unapproved drugs is not an advertisable item, and misleading or exaggerated ads are barred. A website can go beyond the list only if it meets 'limited release' conditions: it must display information that patients seek out themselves, give contact details, describe the usual treatment, cost, risks and side effects for self-pay care, and, for unapproved or off-label use, state that the drug is unapproved, say so if the doctor personally imported it and point to MHLW's page on medicines needing care in personal import, say whether an approved domestic drug with the same ingredient exists, give overseas safety information if the drug is approved in major Western countries (or say that information is lacking), and say the public relief system does not cover it. Banner ads and paid search listings cannot qualify. The MHLW notice of 16 June 2026 restates these limits for GLP-1 and GIP/GLP-1 medicines used for cosmetic or slimming purposes and warns against exaggerated ads.

Every molecule in Japan

MoleculeStatusWhat it meansVerified
AmycretinNot approvedNo marketing approval in Japan; the investigational amylin and GLP-1 agonist amycretin does not appear in PMDA's approved-drug lists to September 2026Details →source2026-09-29
AOD-9604Not approvedNot an approved medicine in Japan; sale and advertising as a drug are illegal, and WADA bans AOD-9604 in sportDetails →source2026-09-29
BPC-157Not approvedNot an approved medicine in Japan; sale and advertising as a drug are illegal, and WADA bans BPC-157 in sportDetails →source2026-09-29
Bremelanotide (PT-141)Not approvedNo marketing approval in Japan; bremelanotide is not in PMDA's approved-drug lists or package-insert databaseDetails →source2026-09-29
Cagrilintide (and CagriSema)Not approvedNo marketing approval in Japan; the amylin analogue cagrilintide does not appear in PMDA's approved-drug lists to September 2026Details →source2026-09-29
CJC-1295Not approvedNot an approved medicine in Japan; sale and advertising as a drug are illegal, and WADA bans CJC-1295 in sportDetails →source2026-09-29
DSIP (delta sleep-inducing peptide)Not approvedNot an approved medicine in Japan; DSIP (delta sleep-inducing peptide) is absent from PMDA's approved-drug lists and package-insert databaseDetails →source2026-09-29
DulaglutideApprovedApproved for type 2 diabetes as Trulicity, on the NHI price list; not approved for obesityDetails →source2026-09-29
EcnoglutideNot approvedNo marketing approval in Japan; the investigational GLP-1 agonist ecnoglutide does not appear in PMDA's approved-drug lists to September 2026Details →source2026-09-29
Elamipretide (SS-31)Not approvedNo marketing approval in Japan; elamipretide is not in PMDA's approved-drug lists or package-insert databaseDetails →source2026-09-29
EloralintideNot approvedNo marketing approval in Japan; the investigational amylin agonist eloralintide does not appear in PMDA's approved-drug lists to September 2026Details →source2026-09-29
EpitalonNot approvedNot an approved medicine in Japan; epitalon is absent from PMDA's approved-drug lists and package-insert databaseDetails →source2026-09-29
ExenatideUnverifiedByetta (2010) and Bydureon (2012) were approved, but exenatide is off the current price list and its marketing status was not confirmedsource2026-09-29
GHK-Cu (copper peptide)Not approvedNot an approved medicine in Japan; GHK-Cu (copper peptide) is absent from PMDA's approved-drug lists and package-insert databaseDetails →source2026-09-29
IpamorelinNot approvedNot an approved medicine in Japan; sale and advertising as a drug are illegal, and WADA bans ipamorelin in sportDetails →source2026-09-29
KisspeptinNot approvedNot an approved medicine in Japan; kisspeptin is absent from PMDA's lists, and WADA bans it in sportDetails →source2026-09-29
KPVNot approvedNot an approved medicine in Japan; KPV is absent from PMDA's approved-drug lists and package-insert databaseDetails →source2026-09-29
LiraglutideApprovedApproved for type 2 diabetes (Victoza, and Xultophy with insulin); no separate weight-loss liraglutide product foundDetails →source2026-09-29
LL-37Not approvedNot an approved medicine in Japan; LL-37 is absent from PMDA's approved-drug lists and package-insert databaseDetails →source2026-09-29
Maridebart cafraglutide (MariTide)Not approvedNo marketing approval in Japan; the investigational antibody-peptide conjugate maridebart cafraglutide does not appear in PMDA's approved-drug lists to September 2026Details →source2026-09-29
MazdutideNot approvedNo marketing approval in Japan; the investigational GLP-1 and glucagon agonist mazdutide does not appear in PMDA's approved-drug lists to September 2026Details →source2026-09-29
Melanotan IINot approvedNot an approved medicine in Japan; sale and advertising as a drug are illegalDetails →source2026-09-29
MOTS-cNot approvedNot an approved medicine in Japan; MOTS-c is absent from PMDA's lists, and WADA bans it in sportDetails →source2026-09-29
NAD+Not approvedNo NAD+ injection is an approved medicine in Japan; sale or advertising as a drug without approval is illegalDetails →source2026-09-29
OrforglipronNot approvedNo marketing approval in Japan; the oral GLP-1 orforglipron does not appear in PMDA's approved-drug lists to September 2026Details →source2026-09-29
PramlintideNot approvedNo marketing approval in Japan; pramlintide (an amylin analogue) is not in PMDA's approved-drug lists or package-insert databaseDetails →source2026-09-29
RetatrutideNot approvedNo marketing approval in Japan; the investigational triple agonist retatrutide does not appear in PMDA's approved-drug lists to September 2026Details →source2026-09-29
SelankNot approvedNot an approved medicine in Japan; Selank is absent from PMDA's approved-drug lists and package-insert databaseDetails →source2026-09-29
SemaglutideApprovedApproved for type 2 diabetes (Ozempic, Rybelsus) and obesity (Wegovy); Wegovy use is limited by an MHLW guidelineDetails →source2026-09-29
SemaxNot approvedNot an approved medicine in Japan; Semax is absent from PMDA's approved-drug lists and package-insert databaseDetails →source2026-09-29
SermorelinNot approvedNot an approved medicine in Japan; sermorelin is absent from PMDA's lists, and WADA bans it in sportDetails →source2026-09-29
SetmelanotideApproved, restrictedApproved on 24 August 2026 as Imcivree, only for acquired hypothalamic obesity; not yet on the NHI price listDetails →source2026-09-29
SurvodutideNot approvedNo marketing approval in Japan; the investigational GLP-1 and glucagon agonist survodutide does not appear in PMDA's approved-drug lists to September 2026Details →source2026-09-29
TB-500 (thymosin beta-4 fragment)Not approvedNot an approved medicine in Japan; sale and advertising as a drug are illegal, and WADA bans TB-500 in sportDetails →source2026-09-29
TesamorelinNot approvedNo marketing approval in Japan; tesamorelin is not in PMDA's approved-drug lists, and WADA prohibits it in sportDetails →source2026-09-29
TirzepatideApprovedApproved for type 2 diabetes (Mounjaro) and obesity (Zepbound), plus sleep apnoea; Zepbound use is limited by an MHLW guidelineDetails →source2026-09-29

For experts

The regulatory detail

Under the PMD Act (Act No. 145 of 1960), Article 14 requires ministerial approval, item by item, before a drug is marketed; PMDA reviews the application and MHLW approves. Art. 55(2) bars selling drugs marketed in breach of Art. 14, Art. 84 sets penalties of up to three years' imprisonment or a fine of up to JPY 3 million, and Art. 49 restricts designated prescription drugs to people holding a prescription. Under the Pharmacists Act, only a pharmacist may dispense (Art. 19, with narrow exceptions for doctors dispensing on their own prescriptions) and only on a prescription (Art. 23); we found no separate statutory route in Japan for bulk or outsourced compounding of unapproved peptides. Individuals may import a prescription drug for personal use up to one month's supply under a customs check, larger quantities need an import confirmation certificate from a regional bureau of health and welfare, and passing the drug to anyone else is not allowed; physicians may import unapproved drugs under their own responsibility. GLP-1 medicines appear on the NHI (national health insurance) price list applicable from 13 August 2026: Ozempic, Rybelsus, Wegovy, Mounjaro, Zepbound, Trulicity and the liraglutide combination Xultophy, with Victoza carrying a transitional-use deadline of 31 March 2027 and Mounjaro marked for new prices from 1 August 2026. Wegovy and Zepbound are subject to MHLW Optimal Use Promotion Guidelines that limit them to qualified facilities and to patients with obesity plus hypertension, dyslipidaemia or type 2 diabetes. On 16 June 2026 MHLW's Pharmaceutical Safety Division and two divisions of its Health Policy Bureau told prefectures, cities with public health centres and special wards that some clinics and pharmacies use GLP-1 and GIP/GLP-1 medicines for cosmetic or slimming purposes outside approved indications, asked them to alert providers, and said supply is normal. The notice also restates advertising limits and asks that off-label cosmetic use be flagged in adverse-reaction reports.

Official sources we monitor

Sources (17)

  1. 01Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), consolidated textDigital Agency (e-Gov Law Search) · 2026-05-21 · accessed 2026-09-29
  2. 02Pharmacists Act (薬剤師法), consolidated textDigital Agency (e-Gov Law Search) · 2026-05-21 · accessed 2026-09-29
  3. 03Approved new drugs list (Japanese), fiscal 2026 to date, covering approvals from May to September 2026 (承認品目一覧（新医薬品）)Pharmaceuticals and Medical Devices Agency (PMDA) · 2026-09 · accessed 2026-09-29
  4. 04Approved new drugs list (Japanese), April 2025 to March 2026 (承認品目一覧（新医薬品：2025年4月～2026年3月）)Pharmaceuticals and Medical Devices Agency (PMDA) · 2026-03 · accessed 2026-09-29
  5. 05List of Approved Drugs, April 2004 to February 2026 (new drugs)Pharmaceuticals and Medical Devices Agency (PMDA) · 2026 · accessed 2026-09-29
  6. 06Prescription drug package insert and review report search (医療用医薬品 添付文書等情報検索)Pharmaceuticals and Medical Devices Agency (PMDA) · 2026-09-29 · accessed 2026-09-29
  7. 07NHI drug price list and generic drug information, applicable from 13 August 2026 (薬価基準収載品目リスト)Ministry of Health, Labour and Welfare (MHLW) · 2026-08-13 · accessed 2026-09-29
  8. 08Optimal Use Promotion Guideline: semaglutide (Wegovy), obesity (revised June 2026)Ministry of Health, Labour and Welfare (MHLW) · 2026-06 · accessed 2026-09-29
  9. 09Optimal Use Promotion Guideline: tirzepatide (Zepbound), obesity (revised May 2026)Ministry of Health, Labour and Welfare (MHLW) · 2026-05 · accessed 2026-09-29
  10. 10Notice on proper use of GLP-1 receptor agonists and GIP/GLP-1 receptor agonists (医薬安発0616第16号)Ministry of Health, Labour and Welfare (MHLW) · 2026-06-16 · accessed 2026-09-29
  11. 11Personal import of pharmaceuticals and related products (医薬品等の個人輸入について)Ministry of Health, Labour and Welfare (MHLW) · 2025 · accessed 2026-09-29
  12. 12Guidance for people buying medicines and related products from overseas (医薬品等を海外から購入しようとされる方へ)Ministry of Health, Labour and Welfare (MHLW) · 2025 · accessed 2026-09-29
  13. 13Notes on personal import of medicines by physicians and dentists (医師・歯科医師の方へ)Ministry of Health, Labour and Welfare (MHLW) · 2012-03 · accessed 2026-09-29
  14. 14Revision of the Standards for Fair Advertising Practices concerning Medicinal Products (医薬品等適正広告基準, notice 薬生発0929第4号)Ministry of Health, Labour and Welfare (MHLW) · 2017-09-29 · accessed 2026-09-29
  15. 15Guidelines on advertising by medical institutions (医療広告等ガイドライン), last revised 30 March 2026Ministry of Health, Labour and Welfare (MHLW) · 2026-03-30 · accessed 2026-09-29
  16. 16World Anti-Doping Code International Standard: Prohibited List 2026World Anti-Doping Agency (WADA) · 2025-09 · accessed 2026-09-29
  17. 17Japan Anti-Doping Agency (JADA) websiteJapan Anti-Doping Agency (JADA) · 2026 · accessed 2026-09-29