Peptide regulatory tracker

What has changed, newest first

62 recorded events.

1. Sep 21, 2026WADA

   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.

   Source: WADA 2027 Prohibited List

   Affects:TesamorelinSermorelinCJC-1295IpamorelinGHRP-2GHRP-6HexarelinMK-677 (ibutamoren)AOD-9604IGF-1 LR3PEG-MGFTB-500 (thymosin beta-4)HCG (human chorionic gonadotropin)GonadorelinKisspeptin-10ACE-031 (ramatercept)InsulinDesmopressinBPC-157MOTS-c

2. Sep 18, 2026FDA

   FDA warning letter treats GLP-1 plus vitamin combinations as essentially copies

   In a warning letter dated September 18, 2026 and posted September 22, FDA said compounded tirzepatide with niacinamide and semaglutide with cyanocobalamin (vitamin B12) appeared to be essentially copies of approved drugs, that the volume produced suggested the claimed differences were a pretext, and that significant-difference statements were repeated verbatim across many records or chosen from preset menus on prescribing platforms. The letter's findings are specific to one pharmacy, but they apply FDA's April 1, 2026 policy that a combination within 10% of approved strengths by the same route may be treated as essentially a copy without a documented prescriber determination.

   Source: FDA warning letter to a compounding pharmacy on semaglutide and tirzepatide vitamin combinations (September 18, 2026)

   Affects:SemaglutideTirzepatide

3. Aug 28, 2026FDA

   FDA approves Mounjaro to reduce cardiovascular risk in adults with type 2 diabetes

   FDA added an indication for Mounjaro to lower the risk of major adverse cardiovascular events (cardiovascular death, non-fatal heart attack, or non-fatal stroke) in adults with type 2 diabetes who are at high risk for these events. The approval rests on SURPASS-CVOT, in which tirzepatide was non-inferior to dulaglutide (hazard ratio 0.92, 95.3% CI 0.83 to 1.01) but did not show superiority.

   Regulatory: FDA approvedSource: Manufacturer press release: FDA approves Mounjaro (tirzepatide) to reduce cardiovascular risk in adults with type 2 diabetes (August 28, 2026)

   Affects:Tirzepatide

4. Aug 19, 2026State board

   Mississippi medical, nursing, and pharmacy boards bar research-grade peptides

   The Mississippi State Board of Medical Licensure, Board of Nursing, and Board of Pharmacy jointly stated that no healthcare provider may compound, administer, dispense, prescribe, advise on, recommend, or supply a non-FDA-approved or research-grade peptide, that consent forms do not remove liability, and that all prescription products and ingredients must come from Board of Pharmacy permitted entities.

   Source: Joint Statement Concerning the Prescribing of Non-FDA Approved (Research-Grade) Peptides (Mississippi Board of Nursing, Board of Pharmacy, State Board of Medical Licensure, August 19, 2026)
5. Aug 1, 2026Other

   Louisiana Act 374 on peptide compounding takes effect

   Louisiana Act 374 of 2026 (Senate Bill 253, La. R.S. 37:23.5), signed May 22, 2026, took effect August 1, 2026. It bars Louisiana licensing boards from prohibiting prescribers from providing peptides made by 503A pharmacies or 503B outsourcing facilities that comply with federal compounding law, and from prohibiting Louisiana pharmacists from compounding peptides in compliance with section 503A. It does not make any peptide eligible for 503A or 503B compounding.

   Source: Louisiana Act No. 374 of 2026 (SB 253), enacting R.S. 37:23.5
6. Jul 24, 2026PCAC

   PCAC votes against adding DSIP to the 503A bulks list

   At the July 23 to 24, 2026 meeting, the Pharmacy Compounding Advisory Committee did not recommend delta sleep-inducing peptide (DSIP) for the 503A bulks list, citing the state of the evidence. FDA makes the final determination by rulemaking.

   Regulatory: Not eligible for compoundingSource: Pharmacy Compounding Advisory Committee

   Affects:DSIP (delta sleep-inducing peptide)

7. Jul 23, 2026PCAC

   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

   Affects:BPC-157KPVTB-500 (thymosin beta-4)MOTS-cSemaxEpitalon

8. Apr 30, 2026FDA

   FDA proposes to keep semaglutide, tirzepatide and liraglutide off the 503B bulks list

   FDA proposed not to include semaglutide, tirzepatide or liraglutide on the 503B bulks list, after tentatively finding no clinical need for outsourcing facilities to compound them from bulk. The notice was published May 1, 2026, and the comment period was extended to July 30, 2026. The proposal was not final as of September 2026. It does not change the 503A rules for patient specific compounding.

   Source: Federal Register 2026-08552: List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B

   Affects:SemaglutideTirzepatideLiraglutide

9. Apr 15, 2026FDA

   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.

   Regulatory: Removed from Category 2 (Apr 2026)Source: FDA: Certain bulk drug substances for use in compounding may present significant safety risks (503A and 503B Category 2 lists and withdrawn nominations, content current as of April 22, 2026)

   Affects:BPC-157AOD-9604CJC-1295DihexaDSIP (delta sleep-inducing peptide)EpitalonGHK-CuIpamorelinKPVLL-37Melanotan IIMOTS-cPEG-MGFSelankSemaxThymosin alpha-1TB-500 (thymosin beta-4)

10. Mar 19, 2026FDA

    FDA approves a 7.2 mg Wegovy dose for chronic weight management

    FDA approved a higher 7.2 mg dose of Wegovy (semaglutide) injection, marketed as Wegovy HD, for weight loss and long-term maintenance of weight loss in certain adults.

    Regulatory: FDA approvedSource: FDA press release: FDA approves fourth product under national priority voucher program, higher dose semaglutide (March 19, 2026)

    Affects:Semaglutide

11. Mar 19, 2026FDA

    FDA approves Imcivree (setmelanotide) for acquired hypothalamic obesity

    FDA extended Imcivree to acquired hypothalamic obesity in adults and children 4 years and older, based on the phase 3 TRANSCEND trial.

    Regulatory: FDA approvedSource: Manufacturer press release: FDA approval of Imcivree for acquired hypothalamic obesity (March 19, 2026)

    Affects:Setmelanotide

12. Jan 1, 2026WADA

    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.

    Source: WADA Prohibited List

    Affects:TesamorelinSermorelinCJC-1295IpamorelinGHRP-2GHRP-6HexarelinMK-677 (ibutamoren)AOD-9604IGF-1 LR3PEG-MGFTB-500 (thymosin beta-4)HCG (human chorionic gonadotropin)GonadorelinKisspeptin-10ACE-031 (ramatercept)InsulinDesmopressinBPC-157MOTS-c

13. Dec 2025FDA

    FDA approves oral semaglutide (Wegovy tablets) for weight management

    In December 2025 FDA approved a once-daily oral formulation of semaglutide for chronic weight management, the first oral GLP-1 receptor agonist approved for obesity.

    Regulatory: FDA approvedSource: Drugs@FDA: Wegovy (semaglutide) NDA 215256

    Affects:Semaglutide

14. Sep 2025FDA

    FDA grants accelerated approval of elamipretide for Barth syndrome

    In September 2025 FDA granted accelerated approval of elamipretide (SS-31), a mitochondria-targeted tetrapeptide, for Barth syndrome, following an earlier complete response letter. Continued approval depends on confirmatory evidence.

    Regulatory: FDA approvedSource: DailyMed: elamipretide labeling

    Affects:SS-31 (elamipretide)

15. Aug 15, 2025FDA

    FDA grants accelerated approval of Wegovy for MASH with fibrosis

    FDA granted accelerated approval of Wegovy (semaglutide 2.4 mg) for adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis, based on histologic endpoints from the ESSENCE trial.

    Regulatory: FDA approvedSource: Drugs@FDA: Wegovy (semaglutide) NDA 215256

    Affects:Semaglutide

16. May 22, 2025FDA

    503B grace period for compounded semaglutide ends

    FDA's enforcement discretion for 503B outsourcing facilities compounding semaglutide ended, closing the shortage-based pathway for compounded semaglutide.

    Source: FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize (Wayback Machine capture of the FDA page, March 13, 2026)

    Affects:Semaglutide

17. Apr 22, 2025FDA

    503A grace period for compounded semaglutide ends

    FDA's enforcement discretion for 503A pharmacies compounding semaglutide ended. After this date 503A pharmacies may not compound copies of Ozempic or Wegovy on shortage grounds.

    Source: FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize (Wayback Machine capture of the FDA page, March 13, 2026)

    Affects:Semaglutide

18. Mar 19, 2025FDA

    503B grace period for compounded tirzepatide ends

    FDA's enforcement discretion for 503B outsourcing facilities compounding tirzepatide ended, closing the shortage-based pathway for compounded tirzepatide.

    Source: FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize (Wayback Machine capture of the FDA page, March 13, 2026)

    Affects:Tirzepatide

19. Feb 21, 2025FDA

    FDA declares the semaglutide shortage resolved

    FDA announced that the shortage of semaglutide injection (Ozempic and Wegovy) was resolved and set enforcement discretion periods: 503A pharmacies until April 22, 2025 and 503B outsourcing facilities until May 22, 2025.

    Source: FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize (Wayback Machine capture of the FDA page, March 13, 2026)

    Affects:Semaglutide

20. Feb 18, 2025FDA

    503A grace period for compounded tirzepatide ends

    FDA's enforcement discretion for 503A pharmacies compounding tirzepatide ended. After this date 503A pharmacies may not compound copies of Mounjaro or Zepbound on shortage grounds.

    Source: FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize (Wayback Machine capture of the FDA page, March 13, 2026)

    Affects:Tirzepatide

21. Jan 28, 2025FDA

    FDA approves Ozempic for chronic kidney disease in type 2 diabetes

    FDA approved Ozempic (semaglutide) to reduce the risk of kidney disease worsening, kidney failure, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease, based on the FLOW trial.

    Regulatory: FDA approvedSource: Drugs@FDA: Ozempic (semaglutide) NDA 209637

    Affects:Semaglutide

22. Jan 1, 2025WADA

    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.

    Source: WADA Prohibited List

    Affects:TesamorelinSermorelinCJC-1295IpamorelinGHRP-2GHRP-6HexarelinMK-677 (ibutamoren)AOD-9604IGF-1 LR3PEG-MGFTB-500 (thymosin beta-4)HCG (human chorionic gonadotropin)GonadorelinKisspeptin-10ACE-031 (ramatercept)InsulinDesmopressinBPC-157

23. Dec 20, 2024FDA

    FDA approves Zepbound for obstructive sleep apnea in adults with obesity

    FDA approved Zepbound (tirzepatide) for moderate to severe obstructive sleep apnea in adults with obesity, the first drug approved for that indication.

    Regulatory: FDA approvedSource: FDA approves first medication for obstructive sleep apnea

    Affects:Tirzepatide

24. Dec 19, 2024FDA

    FDA reaffirms the tirzepatide shortage is resolved and sets grace periods

    After reconsideration, FDA confirmed the tirzepatide shortage was resolved and announced enforcement discretion periods: 503A pharmacies until February 18, 2025 and 503B outsourcing facilities until March 19, 2025.

    Source: FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize (Wayback Machine capture of the FDA page, March 13, 2026)

    Affects:Tirzepatide

25. Dec 2024FDA

    FDA approves the first generic liraglutide injection

    In December 2024 FDA approved the first generic version of once-daily liraglutide injection referencing Victoza, the first generic GLP-1 receptor agonist in the US.

    Regulatory: FDA approvedSource: First generic drug approvals

    Affects:Liraglutide

26. Oct 11, 2024Other

    FDA agrees to reconsider the tirzepatide shortage decision after compounder lawsuit

    After the Outsourcing Facilities Association sued over the October 2 resolution decision, FDA told the court it would reconsider the tirzepatide shortage determination and would not take enforcement action against compounders in the interim.

    Source: FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize (Wayback Machine capture of the FDA page, March 13, 2026)

    Affects:Tirzepatide

27. Oct 2, 2024FDA

    FDA declares the tirzepatide shortage resolved

    FDA announced that the shortage of tirzepatide injection (Mounjaro and Zepbound) was resolved, meaning compounders could no longer rely on the shortage to prepare copies of the approved products.

    Source: FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize (Wayback Machine capture of the FDA page, March 13, 2026)

    Affects:Tirzepatide

28. Mar 8, 2024FDA

    FDA approves Wegovy to reduce cardiovascular risk in adults with obesity

    FDA approved a new indication for Wegovy (semaglutide 2.4 mg) to reduce the risk of major adverse cardiovascular events in adults with established cardiovascular disease and obesity or overweight, based on the SELECT trial.

    Regulatory: FDA approvedSource: FDA approves first treatment to reduce risk of serious heart problems specifically in adults with obesity or overweight

    Affects:Semaglutide

29. Nov 8, 2023FDA

    FDA approves Zepbound (tirzepatide) for chronic weight management

    FDA approved tirzepatide injection (Zepbound) for chronic weight management in adults with obesity or overweight with at least one weight-related condition.

    Regulatory: FDA approvedSource: FDA approves new medication for chronic weight management

    Affects:Tirzepatide

30. Sep 29, 2023FDA

    FDA places GHRP-2, GHRP-6, and ipamorelin in 503B Category 2

    On September 29, 2023 FDA added growth hormone releasing peptide-2 (GHRP-2, for injectable and nasal routes), GHRP-6, and ipamorelin acetate to Category 2 under the 503B interim policy, citing immunogenicity risk from aggregation and peptide related impurities and, for GHRP-2, reports of serious adverse events. Outsourcing facilities may not compound a substance while it is in 503B Category 2. All three remain listed on the FDA page current as of April 22, 2026.

    Regulatory: Not eligible for compoundingSource: FDA: Certain bulk drug substances for use in compounding may present significant safety risks (503A and 503B Category 2 lists and withdrawn nominations, content current as of April 22, 2026)

    Affects:GHRP-2GHRP-6Ipamorelin

31. Sep 2023FDA

    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.

    Regulatory: Not eligible for compoundingSource: FDA: Certain bulk drug substances for use in compounding may present significant safety risks (503A and 503B Category 2 lists and withdrawn nominations, content current as of April 22, 2026)

    Affects:BPC-157CJC-1295IpamorelinAOD-9604DihexaDSIP (delta sleep-inducing peptide)EpitalonKPVMOTS-cSelankSemaxMelanotan IILL-37Thymosin alpha-1TB-500 (thymosin beta-4)Kisspeptin-10MK-677 (ibutamoren)

32. May 2023FDA

    FDA warns about compounded semaglutide made with salt forms

    In May 2023 FDA published its concerns about compounded semaglutide, stating it had received adverse event reports and that products made with semaglutide sodium or semaglutide acetate salts are not the same active ingredient as the approved drugs and do not meet the compounding exemption requirements.

    Source: FDA's concerns with unapproved GLP-1 drugs used for weight loss

    Affects:Semaglutide

33. Dec 23, 2022FDA

    FDA expands Wegovy to adolescents aged 12 and older

    FDA approved Wegovy (semaglutide 2.4 mg) for chronic weight management in pediatric patients aged 12 years and older with obesity, based on the STEP TEENS trial.

    Regulatory: FDA approvedSource: Drugs@FDA: Wegovy (semaglutide) NDA 215256

    Affects:Semaglutide

34. Dec 2022FDA

    FDA lists tirzepatide injection on the drug shortage list

    In December 2022 FDA added tirzepatide injection (Mounjaro) to its drug shortage list, opening the door to compounded tirzepatide under FDA's shortage compounding policies.

    Source: FDA drug shortages database

    Affects:Tirzepatide

35. Sep 14, 2022FDA

    FDA approves Terlivaz (terlipressin) for hepatorenal syndrome

    FDA approved terlipressin injection (Terlivaz), a vasopressin analog, to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.

    Regulatory: FDA approvedSource: Drugs@FDA: Terlivaz (terlipressin) NDA 022231

    Affects:Terlipressin

36. May 13, 2022FDA

    FDA approves Mounjaro (tirzepatide) for type 2 diabetes

    FDA approved tirzepatide injection (Mounjaro), the first dual GIP and GLP-1 receptor agonist, to improve glycemic control in adults with type 2 diabetes.

    Regulatory: FDA approvedSource: Drugs@FDA: Mounjaro (tirzepatide) NDA 215866

    Affects:Tirzepatide

37. Mar 2022FDA

    FDA lists semaglutide injection on the drug shortage list

    In March 2022 FDA added semaglutide injection to its drug shortage list as demand for Wegovy and Ozempic outpaced supply. While a drug is in shortage, 503A and 503B compounders may prepare essentially a copy under FDA's shortage-related compounding policies.

    Source: FDA drug shortages database

    Affects:Semaglutide

38. Jan 1, 2022WADA

    WADA 2022 Prohibited List adds BPC-157 as an S0 example

    The 2022 WADA Prohibited List took effect on January 1, 2022 and named BPC-157 as an example of a non-approved substance under section S0, making it prohibited at all times for athletes under the World Anti-Doping Code.

    Source: WADA Prohibited List

    Affects:BPC-157

39. Nov 19, 2021FDA

    FDA approves Voxzogo (vosoritide) for achondroplasia

    FDA approved vosoritide injection (Voxzogo), a C-type natriuretic peptide analog, to increase linear growth in children with achondroplasia and open epiphyses, under accelerated approval.

    Regulatory: FDA approvedSource: Drugs@FDA: Voxzogo (vosoritide) NDA 214938

    Affects:Vosoritide

40. Jun 4, 2021FDA

    FDA approves Wegovy (semaglutide 2.4 mg) for chronic weight management

    FDA approved once-weekly semaglutide 2.4 mg injection (Wegovy) for chronic weight management in adults with obesity or overweight with at least one weight-related condition, the first new weight-management drug approved since 2014.

    Regulatory: FDA approvedSource: Drugs@FDA: Wegovy (semaglutide) NDA 215256

    Affects:Semaglutide

41. Nov 25, 2020FDA

    FDA approves Imcivree (setmelanotide) for rare genetic obesity

    FDA approved setmelanotide injection (Imcivree), an MC4R agonist, for chronic weight management in patients with obesity due to POMC, PCSK1, or LEPR deficiency confirmed by genetic testing.

    Regulatory: FDA approvedSource: Drugs@FDA: Imcivree (setmelanotide) NDA 213793

    Affects:Setmelanotide

42. Mar 23, 2020FDA

    Egrifta (tesamorelin) is deemed a biologics license

    Under the biologics transition provision of the Biologics Price Competition and Innovation Act, FDA deemed the Egrifta application (022505) to be a biologics license on March 23, 2020. FDA states that biological products are not eligible for the 503A or 503B compounding exemptions, so tesamorelin cannot be lawfully compounded; the approved product remains available by prescription.

    Regulatory: FDA approvedSource: FDA: List of approved NDAs for biological products that were deemed to be BLAs on March 23, 2020 (includes tesamorelin, Egrifta and Egrifta SV, application 022505)

    Affects:Tesamorelin

43. Jan 16, 2020FDA

    FDA adds cardiovascular risk reduction to the Ozempic label

    FDA approved a label expansion for Ozempic (semaglutide) to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease, based on the SUSTAIN-6 trial.

    Regulatory: FDA approvedSource: Drugs@FDA: Ozempic (semaglutide) NDA 209637

    Affects:Semaglutide

44. Oct 8, 2019FDA

    FDA approves Scenesse (afamelanotide) for erythropoietic protoporphyria

    FDA approved afamelanotide implant (Scenesse) to increase pain-free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria. Afamelanotide is the only approved melanotan-class peptide.

    Regulatory: FDA approvedSource: Drugs@FDA: Scenesse (afamelanotide) NDA 210797

    Affects:Melanotan I (afamelanotide)

45. Sep 20, 2019FDA

    FDA approves Rybelsus, the first oral GLP-1 receptor agonist

    FDA approved oral semaglutide tablets (Rybelsus) for adults with type 2 diabetes, the first GLP-1 receptor agonist available in a pill rather than an injection.

    Regulatory: FDA approvedSource: Drugs@FDA: Rybelsus (semaglutide tablets) NDA 213051

    Affects:Semaglutide

46. Jun 21, 2019FDA

    FDA approves Vyleesi (bremelanotide) for hypoactive sexual desire disorder

    FDA approved bremelanotide injection (Vyleesi), a melanocortin receptor agonist, for premenopausal women with acquired, generalized hypoactive sexual desire disorder.

    Regulatory: FDA approvedSource: Drugs@FDA: Vyleesi (bremelanotide) NDA 210557

    Affects:PT-141 (bremelanotide)

47. Feb 19, 2019Federal Register

    FDA publishes first final rule for the 503A bulk drug substances list

    FDA finalized the first rule establishing the list of bulk drug substances that may be used in compounding under section 503A, and confirmed the interim Category 1, 2, and 3 framework used to evaluate nominated substances. Category 2 substances raise significant safety risks and may not be compounded under the interim policy.

    Source: Bulk drug substances used in compounding under section 503A of the FD&C Act
48. Dec 5, 2017FDA

    FDA approves Ozempic (semaglutide) for type 2 diabetes

    FDA approved once-weekly semaglutide injection (Ozempic) to improve glycemic control in adults with type 2 diabetes, the first semaglutide product to reach the US market.

    Regulatory: FDA approvedSource: Drugs@FDA: Ozempic (semaglutide) NDA 209637

    Affects:Semaglutide

49. Apr 28, 2017FDA

    FDA approves Tymlos (abaloparatide) for postmenopausal osteoporosis

    FDA approved abaloparatide injection (Tymlos), a parathyroid hormone-related protein analog, for postmenopausal women with osteoporosis at high risk of fracture.

    Regulatory: FDA approvedSource: Drugs@FDA: Tymlos (abaloparatide) NDA 208743

    Affects:Abaloparatide

50. Dec 23, 2014FDA

    FDA approves Saxenda (liraglutide 3 mg) for chronic weight management

    FDA approved liraglutide 3 mg injection (Saxenda) for chronic weight management in adults with obesity or overweight with at least one weight-related condition, as an adjunct to diet and exercise.

    Regulatory: FDA approvedSource: Drugs@FDA: Saxenda (liraglutide) NDA 206321

    Affects:Liraglutide

51. Sep 18, 2014FDA

    FDA approves Trulicity (dulaglutide) for type 2 diabetes

    FDA approved once-weekly dulaglutide injection (Trulicity) to improve glycemic control in adults with type 2 diabetes.

    Regulatory: FDA approvedSource: Drugs@FDA: Trulicity (dulaglutide) BLA 125469

    Affects:Dulaglutide

52. Aug 30, 2012FDA

    FDA approves Linzess (linaclotide) for IBS-C and chronic constipation

    FDA approved linaclotide capsules (Linzess), a guanylate cyclase-C agonist peptide, for irritable bowel syndrome with constipation and chronic idiopathic constipation in adults.

    Regulatory: FDA approvedSource: Drugs@FDA: Linzess (linaclotide) NDA 202811

    Affects:Linaclotide

53. Jan 27, 2012FDA

    FDA approves Bydureon, once-weekly extended-release exenatide

    FDA approved the extended-release, once-weekly formulation of exenatide (Bydureon) for type 2 diabetes after earlier complete response letters.

    Regulatory: FDA approvedSource: Drugs@FDA: Bydureon (exenatide extended-release) NDA 022200

    Affects:Exenatide

54. Nov 10, 2010FDA

    FDA approves Egrifta (tesamorelin) for HIV-associated lipodystrophy

    FDA approved tesamorelin injection (Egrifta), a growth hormone-releasing hormone analog, to reduce excess abdominal fat in HIV-infected adults with lipodystrophy.

    Regulatory: FDA approvedSource: Drugs@FDA: Egrifta (tesamorelin) NDA 022505

    Affects:Tesamorelin

55. Jan 25, 2010FDA

    FDA approves Victoza (liraglutide) for type 2 diabetes

    FDA approved once-daily liraglutide injection (Victoza) to improve glycemic control in adults with type 2 diabetes, with a boxed warning about thyroid C-cell tumors seen in rodents.

    Regulatory: FDA approvedSource: Drugs@FDA: Victoza (liraglutide) NDA 022341

    Affects:Liraglutide

56. Dec 24, 2008FDA

    FDA approves Firmagon (degarelix) for advanced prostate cancer

    FDA approved degarelix injection (Firmagon), a GnRH receptor antagonist peptide, for adults with advanced prostate cancer.

    Regulatory: FDA approvedSource: Drugs@FDA: Firmagon (degarelix) NDA 022201

    Affects:Degarelix

57. Aug 30, 2007FDA

    FDA approves Somatuline Depot (lanreotide) for acromegaly

    FDA approved lanreotide injection (Somatuline Depot), a somatostatin analog, for the long-term treatment of acromegaly in patients who have had an inadequate response to surgery or radiotherapy.

    Regulatory: FDA approvedSource: Drugs@FDA: Somatuline Depot (lanreotide) NDA 022074

    Affects:Lanreotide

58. Apr 28, 2005FDA

    FDA approves Byetta (exenatide), the first GLP-1 receptor agonist

    FDA approved twice-daily exenatide injection (Byetta) as adjunctive therapy for type 2 diabetes, the first GLP-1 receptor agonist to reach the US market.

    Regulatory: FDA approvedSource: Drugs@FDA: Byetta (exenatide) NDA 021773

    Affects:Exenatide

59. Mar 16, 2005FDA

    FDA approves Symlin (pramlintide) as an adjunct to insulin

    FDA approved pramlintide injection (Symlin), a synthetic amylin analog, for use with mealtime insulin in type 1 and type 2 diabetes.

    Regulatory: FDA approvedSource: Drugs@FDA: Symlin (pramlintide) NDA 021332

    Affects:Pramlintide

60. Dec 28, 2004FDA

    FDA approves Prialt (ziconotide) for severe chronic pain

    FDA approved intrathecal ziconotide (Prialt), a synthetic cone snail peptide that blocks N-type calcium channels, for severe chronic pain in patients who need intrathecal therapy.

    Regulatory: FDA approvedSource: Drugs@FDA: Prialt (ziconotide) NDA 021060

    Affects:Ziconotide

61. Mar 13, 2003FDA

    FDA approves Fuzeon (enfuvirtide), the first HIV fusion inhibitor

    FDA approved enfuvirtide injection (Fuzeon), a 36-amino-acid peptide that blocks HIV-1 fusion with host cells, for treatment-experienced patients with HIV-1.

    Regulatory: FDA approvedSource: Drugs@FDA: Fuzeon (enfuvirtide) NDA 021481

    Affects:Enfuvirtide

62. Nov 26, 2002FDA

    FDA approves Forteo (teriparatide) for osteoporosis

    FDA approved teriparatide injection (Forteo), a recombinant parathyroid hormone fragment, for postmenopausal women with osteoporosis at high risk of fracture and to increase bone mass in men with primary or hypogonadal osteoporosis.

    Regulatory: FDA approvedSource: Drugs@FDA: Forteo (teriparatide) NDA 021318

    Affects:Teriparatide