What changed.

regulatory: FDA scheduled its Pharmacy Compounding Advisory Committee (PCAC) to review Emideltide (DSIP)-related bulk drug substances for potential inclusion on the 503A Bulks List at a July 23-24, 2026 meeting. Removal from Category 2 ('Do Not Compound') was set to take effect April 23, 2026, ahead of the formal PCAC review. No approval granted yet. (FDA.gov, 2026-04-16)

regulatory: Semax-related bulk drug substances (free base and acetate forms) are among the peptides slated for PCAC review on July 24, 2026 for possible 503A Bulks List inclusion. FDA removed Semax from Category 2 effective April 23, 2026, pending the committee's non-binding recommendation and subsequent formal rulemaking. (FDA.gov, 2026-04-16)

regulatory: FDA announced a second PCAC meeting, to be held before end of February 2027, that will review GHK-Cu for the 503A Bulks List alongside LL-37, Dihexa, and PEG-MGF. The substance remains in regulatory limbo until formal rulemaking follows any committee recommendation. (TheFDALawBlog.com, 2026-04-21)

regulatory: FDA approved orforglipron (branded Foundayo) on April 1, 2026 — the first small-molecule oral GLP-1 receptor agonist cleared for weight management, taken once daily with no food or water restrictions. Starting dose is 0.8 mg, titrated to 5.5 mg. Approval was granted to Eli Lilly under the National Priority Voucher Program. (FDA.gov, 2026-04-01)

evidence: Eli Lilly's TRIUMPH-1 Phase 3 trial (2,339 patients, 80 weeks) reported 28.3% mean weight loss at the 12 mg dose on May 21, 2026, consistent with TRIUMPH-4 results (28.7%). NDA submission expected Q4 2026; FDA review and potential approval not anticipated before 2027–2028. (retaweightloss.com, 2026-05-21)

regulatory: TB-500 (Thymosin Beta-4) is among 12 peptides FDA moved out of Category 2 as of April 15, 2026, easing compounding restrictions. GHK-Cu (injectable), LL-37, PEG-MGF, and Melanotan II are on a separate track for PCAC review before February 2027. Removal from Category 2 does not constitute FDA approval or placement on the Category 1 'May Compound' list. (Frier Levitt / FDA, 2026-04-16)

regulatory: On April 15, 2026, FDA announced intent to remove BPC-157 (along with 11 other peptides) from the Category 2 'Do Not Compound' list within 7 days, withdrawing prior significant-safety-concern designations. A PCAC advisory meeting is scheduled July 23–24, 2026 to consider 503A bulks-list inclusion; formal rulemaking still required before compounding is definitively permitted. (SSRP Institute / FDA, 2026-04-15)

regulatory: FDA approved orforglipron (brand: Foundayo) on April 1, 2026 as an oral GLP-1 receptor partial agonist for adult obesity/overweight with comorbidity — the first small-molecule GLP-1 pill with no food or water restrictions. Approved 294 days ahead of its PDUFA date under the Commissioner's National Priority Voucher program, marking the fastest NME approval since 2002. (FDA.gov, 2026-04-01)

evidence: TRIUMPH-1 pivotal Phase 3 trial (NCT; 2,339 adults with obesity, 80 weeks) reported positive top-line results: 28.3% average body-weight loss at the 12 mg dose. No NDA filed yet; regulatory submission expected Q4 2026 per tracker. (retaweightloss.com, 2026-06-09)

regulatory: Same FDA Category 2 removal (effective April 23, 2026) covers TB-500; PCAC will assess compounding eligibility at its July 23–24, 2026 meeting. Pharmacy Times notes reclassification is a compounding-access change only, not an approval signal. (Pharmacy Times, 2026-06-10)

regulatory: Pharmacy Times editorial (published ~June 10, 2026) clarifies that FDA removal of BPC-157 and 11 other peptides from Category 2, effective April 23, 2026, permits compounding by licensed pharmacies but does not constitute drug approval. PCAC formal review scheduled July 23–24, 2026. (Pharmacy Times, 2026-06-10)

regulatory: FDA approved orforglipron (brand name Foundayo), an oral non-peptide GLP-1 receptor agonist, for obesity and overweight in adults. Approval listed on Drugs.com new approvals page, last updated June 1, 2026. First oral GLP-1-class agent cleared for weight management. (Drugs.com FDA approvals, 2026-06-01)

evidence: First detailed REIMAGINE 1/2/3 Phase 3 trial data for CagriSema (cagrilintide + semaglutide) in type 2 diabetes presented at ADA Scientific Sessions, New Orleans, June 7, 2026. Topline data showed superior A1C reduction and weight loss vs. either component alone. FDA submission for weight-loss indication was made in late 2025. (ADA Meeting News, 2026-06-07)

regulatory: On April 15, 2026, FDA announced intent to remove BPC-157, TB-500, LL-37, DSIP, Epitalon, GHK-Cu (injectable), KPV, PEG-MGF, Melanotan II, MOTS-C, Semax, and Dihexa from the 503A Category 2 'Do Not Compound' list within 7 days. PCAC will review these peptides for possible Category 1 inclusion at its July 23–24, 2026 meeting. Formal rulemaking still required. (FDA via SSRP Institute / Frier Levitt, 2026-04-15)

evidence: ADA 2026 Scientific Sessions (June 7) featured first detailed REIMAGINE trial readouts for CagriSema (cagrilintide + semaglutide) in T2D; combination outperformed semaglutide monotherapy on glycemic control and weight. On-demand access opens June 10, 2026. (ADA Meeting News, 2026-06-07)

regulatory: FDA approved orforglipron (brand name Foundayo) as an oral GLP-1 receptor partial agonist for chronic weight management in adults with obesity or overweight with comorbidities. Approved April 1, 2026 under the CNPV pilot program — 294 days ahead of its PDUFA date — marking the fastest NME approval since 2002. No food/water restrictions required at dosing. (FDA.gov, 2026-04-01)

news: Phase 3 data presented at ADA 86th Scientific Sessions (June 8, New Orleans). Oral GLP-1 agonist already launched April 2026 at $149/month self-pay; ADA noted adherence advantages but flagged absence of outcomes-level cardiovascular evidence vs. injectable peers. (TechTimes/ADA, 2026-06-08)

editorial: EASO updated obesity treatment algorithm published simultaneously at ECO 2026 in Nature Medicine now formally separates tirzepatide and semaglutide roles based on SURMOUNT-5 head-to-head evidence; expands evidence base from 56 to 62 trials. (Nature Medicine/ECO 2026, 2026-06-08)

regulatory: CagriSema (cagrilintide + semaglutide) NDA filed with FDA December 2025; Phase 3 data spotlighted at ADA Sessions closing June 8. Approval expected Q4 2026–Q1 2027. Novo Nordisk also announced plans for higher-dose (7.2 mg cagrilintide) trials starting late 2026. (ADA/retaweightloss.com, 2026-06-08)

evidence: Full Phase 3 TRIUMPH-1 results presented at ADA 86th Scientific Sessions (New Orleans, closed June 8) and simultaneously published in The Lancet: 28.3% avg weight loss at 80 weeks in 2,339 adults with obesity. Safety profile consistent with incretin class. NDA submission still targeted Q4 2026. (Lilly/The Lancet, 2026-06-08)

evidence: Lilly released full Phase 3 TRANSCEND-T2D-1 data at ADA 86th Scientific Sessions and simultaneously published in The Lancet (June 6, 2026). Trial enrolled adults with type 2 diabetes; topline showed 16.8% weight loss and a 2.0 percentage-point A1C reduction. Seven additional Phase 3 readouts remain pending through 2026. FDA filing expected late 2026. (Eli Lilly / The Lancet, 2026-06-06)

regulatory: Clarivate's Drugs to Watch 2026 report (cited by PharmExec, published June 8, 2026) projects orforglipron—Lilly's once-daily oral non-peptide GLP-1 agonist—could reach $16B in sales by 2031. FDA decision was anticipated by March 2026; commercial launch trajectory and regulatory outcome remain closely watched amid evolving US pricing and HTA pressures. (PharmExec / Clarivate, 2026-06-08)

regulatory: CagriSema NDA (semaglutide co-formulated with cagrilintide) under FDA review with decision window Q4 2026–Q1 2027. Semaglutide component leverages existing Wegovy approval infrastructure. Analyst consensus projects CagriSema market launch ~mid-2027, 6–12 months ahead of retatrutide. (Novo Nordisk / Today.com, 2026-01-20)

regulatory: Novo Nordisk's CagriSema (cagrilintide + semaglutide fixed-ratio combo) NDA filed with FDA in Dec 2025; approval now expected Q4 2026 or Q1 2027 per analyst tracking. Phase 3 REDEFINE data showed ~20% avg body-weight loss vs ~15% for semaglutide alone. Novo also signaled plans for higher-dose (7.2 mg cagrilintide) trials starting late 2026. (Novo Nordisk NDA filing / Today.com, 2026-01-20)

evidence: Eli Lilly's Phase 3 TRIUMPH-4 trial reported that retatrutide 9 mg and 12 mg both met all primary and key secondary endpoints, reducing knee osteoarthritis pain and CV risk factors alongside weight loss of up to 28.7%. Seven additional Phase 3 readouts across obesity, T2D, liver disease, and sleep apnea are expected in 2026. NDA filing anticipated Q4 2026 at earliest. (PatientCareOnline, 2026-06-07)

regulatory: Novo Nordisk's CagriSema (cagrilintide + semaglutide) NDA is under FDA review with a decision expected in 2026, based on REDEFINE 1 Phase 3 data showing 20.4% weight loss at 68 weeks. Cagrilintide alone showed a 17% injection-site reaction rate, flagged as a tolerability concern ahead of the FDA decision. (BioSpace / GoodRx, 2026-06-01)

regulatory: TB-500 is among peptides slated for FDA Compounding Advisory Committee review on July 23–24, 2026. HHS indicated it may return to Category 1, reopening a legal compounding pathway. A pharmacist commentary notes TB-500 still has no completed human RCTs; reclassification restores access but does not validate efficacy. (PharmacyTimes, 2026-06-07)

regulatory: FDA's Pharmacy Compounding Advisory Committee is formally scheduled for July 23–24, 2026 to evaluate whether BPC-157, KPV, TB-500, and MOTS-C meet criteria for the 503A Bulk Drug Substances List, following HHS Secretary RFK Jr.'s Feb 2026 announcement to ease compounding restrictions on ~14 peptides. (DrugTopics, 2026-06-03)

regulatory: FDA removed BPC-157 from Category 2 effective April 23, 2026, with the Pharmacy Compounding Advisory Committee (PCAC) scheduled to formally review it for 503A Bulk Drug Substances List inclusion on July 23–24, 2026. PCAC recommendation is non-binding; notice-and-comment rulemaking still required before compounding is officially permitted. (Pharmacy Times, 2026-06-05)

regulatory: Injectable GHK-Cu was included in the April 15, 2026 FDA Category 2 removal announcement; non-injectable GHK-Cu singled out for a separate PCAC review by February 2027. FDA noted the PCAC will also evaluate GHK-Cu, Melanotan II, LL-37, Dihexa, and PEG-MGF at a second meeting before end of Feb 2027. (FDA Law Blog / SSRP Institute, 2026-04-16)

regulatory: TB-500 (Thymosin Beta-4) was among 12 peptides removed from FDA Category 2 effective April 23, 2026, per a Federal Register notice. PCAC will review at July 23–24, 2026 meeting. Melanotan II, GHRP-2, GHRP-6, LL-37, and PEG-MGF are expected to remain restricted due to ongoing safety concerns. Full rulemaking still required. (Pharmacy Times, 2026-06-05)

regulatory: FDA approved orforglipron (brand: Foundayo) on April 1, 2026 — an oral GLP-1 receptor partial agonist for chronic weight management in adults with obesity or overweight with comorbidities. Starting dose 0.8 mg daily, titrated up to 17.2 mg. First NME approved under the CNPV pilot program; fastest NME approval since 2002. Granted to Eli Lilly. (FDA.gov, 2026-04-01)

evidence: Medscape reports ADA 2026 will feature phase 3 ACHIEVE trial data comparing orforglipron head-to-head with oral semaglutide in T2D (ACHIEVE-3), and CagriSema phase 3 data showing CagriSema outperformed semaglutide alone for glucose and weight but underperformed vs. tirzepatide. Sessions scheduled for June 2026 ADA meeting. (Medscape, 2026-06-01)

regulatory: FDA's Pharmacy Compounding Advisory Committee (PCAC) announced it will convene before end of Feb 2027 to review GHK-Cu, Melanotan II, LL-37, Dihexa, and PEG-MGF for the 503A Bulk Drug Substances List. FDA also updated Category 2 status to allow removal within 7 days pending review. Formal rulemaking still required after PCAC recommendation. (TheFDALawBlog, 2026-04-21)

evidence: ADA 2026 agenda includes three new phase 3 CagriSema trials in T2D: monotherapy in drug-naive patients, comparison vs. semaglutide or cagrilintide on metformin, and add-on to basal insulin. REDEFINE 1 phase 3 data previously showed 22.7% weight loss. (Medscape, 2026-06-01)

regulatory: FDA approved orforglipron (branded Foundayo, Eli Lilly) as an oral GLP-1 receptor agonist tablet for weight management in adults with obesity or overweight — the first oral GLP-1 pill with no food or water timing restrictions. Starting dose is 0.8 mg daily, titrating to 5.5 mg. Approval dated April 1, 2026. (Drugs.com / FDA.gov, 2026-04-01)

regulatory: ADA 2026 (June 5) will present REIMAGINE-1/2/3 — first data for CagriSema (cagrilintide+semaglutide) as monotherapy, vs. components, and as add-on to basal insulin in T2D. FDA NDA for weight loss was submitted end of 2025; approval expected Q4 2026–Q1 2027. (HCPLive, 2026-06-03)

trial_dose: SYNCHRONIZE-1 data on survodutide (GLP-1/glucagon dual agonist, Breakthrough Therapy designation) to be presented at ADA 2026 Scientific Sessions starting June 5, showing substantial placebo-adjusted weight loss and waist-circumference reductions in non-diabetic obesity. (HCPLive, 2026-06-03)

evidence: EASO updated its 2026 obesity algorithm (published Nature Medicine, ECO 2026) expanding evidence base from 56 to 62 trials. Framework now shows clearer separation between tirzepatide and semaglutide for weight loss based on SURMOUNT-5 head-to-head data. (Medscape/Nature Medicine, 2026-05-20)

trial_dose: ADA 2026 Scientific Sessions (June 5, New Orleans) set to feature TRANSCEND-T2D-1 data showing retatrutide superior to placebo on HbA1c and weight in T2D. Eli Lilly's Q4 2026 NDA submission target confirmed on Q1 earnings call; TRIUMPH-4 previously reported 28.7% weight loss in obesity+osteoarthritis patients. (HCPLive, 2026-06-03)

regulatory: FDA approved once-daily oral semaglutide 25mg (Wegovy pill) for weight loss and MACE risk reduction — the first oral GLP-1 agonist approved for obesity. Novo Nordisk launched in the US in January 2026. Approval based on OASIS trials; OASIS 4 showed 13.6% mean weight loss at 64 weeks. (AJMC, 2026-01)

regulatory: Novo Nordisk's NDA for CagriSema (cagrilintide 2.4mg + semaglutide 2.4mg, once-weekly injection) remains under FDA review in 2026. REDEFINE 1 Phase 3 (3,400+ adults, no diabetes) showed 20.4% mean weight loss vs 3.0% placebo at 68 weeks. FDA decision expected later in 2026. (BioSpace / GoodRx, 2026)

regulatory: FDA announced it will remove BPC-157, TB-500, LL-37, DSIP, Epitalon, GHK-Cu (injectable), KPV, PEG-MGF, Melanotan II, MOTS-C, and Semax from Category 2 bulk drug substances, easing compounding restrictions. FDA's Pharmacy Compounding Advisory Committee July 2026 meeting will explore further status. (SSRP Institute, 2026-04-15)

regulatory: FDA approved Foundayo (orforglipron) on April 1, 2026 as an oral GLP-1 receptor agonist for weight management in adults with obesity or overweight with related conditions — notable as the only GLP-1 pill with no food or water restrictions at dosing. (Drugs.com, 2026-04-01)

regulatory: FDA reportedly delayed its decision on Eli Lilly's oral GLP-1 pill orforglipron, according to a Biospace report flagged in GoodRx's upcoming-approvals tracker. No new PDUFA date confirmed publicly as of filing. (GoodRx/Biospace, 2026-05-29)

regulatory: FDA's April 23, 2026 reclassification moved BPC-157 and ~11 other peptides off the Category 2 restricted list; PCAC will formally review compounding eligibility at its July 23–24, 2026 meeting. Non-injectable GHK-Cu flagged separately for February 2027 review. (BioPharma Dive, 2026-04-16)

regulatory: Wegovy (semaglutide) flagged as a 2026 candidate for FDA approval in heart failure with preserved ejection fraction (HFpEF) in obese adults, per GoodRx upcoming-approvals tracker. Ozempic PAD indication decision also still pending. (GoodRx, 2026-04-13)

regulatory: Non-injectable GHK-Cu singled out by FDA for a separate compounding-eligibility review, targeted for February 2027, following the April 23, 2026 reclassification that removed it from the Category 2 bulk-substances ban. PCAC July 2026 meeting will cover the broader peptide group. (SSRP Institute, 2026-04-15)

regulatory: FDA announced a second PCAC meeting before end of February 2027 to review injectable GHK-Cu, Melanotan II, LL-37, Dihexa acetate, and PEG-MGF for 503A Bulks List addition. Non-injectable GHK-Cu is under separate consideration. No public docket has yet been opened for this later meeting. (RAPS / FDA Law Blog, 2026-04-16)

regulatory: FDA's Pharmacy Compounding Advisory Committee (PCAC) confirmed for July 23, 2026 to review BPC-157 (free base & acetate) for potential inclusion on the 503A Bulks List for ulcerative colitis. Public comment docket FDA-2025-N-6895 closes July 22. PCAC recommendation is non-binding; formal notice-and-comment rulemaking still required. (FDA.gov / RAPS, 2026-04-16)