Evidence review: Open Peptide Project (verified against primary PubMed, ClinicalTrials.gov & FDA records) · Last checked 2026-10-27 · Jump to 40-Event Calendar ↓ · Jump to Trial Readout Entries ↓

Peptide News & Clinical Trial Readout Tracker

A sourced record of what is happening in peptide clinical research and regulation—covering Phase 2/3 trial results, FDA/EMA regulatory decisions, and upcoming readout dates. Written for both the general public and medical professionals. Zero sales, zero hype, zero dosing advice.

Level A Phase 3 RCT, peer-reviewed
Published in a peer-reviewed journal with full trial data.
Level B Phase 2 RCT (peer-reviewed) or Phase 3 abstract
Peer-reviewed mid-stage trial or late-breaking conference data.
Level C Sponsor topline announcement / Phase 1–2 abstract
Company press release prior to peer review; updated when the full paper lands.
Level D Post hoc / subgroup / observational
Exploratory or secondary analysis; hypothesis-generating.
Level R Regulatory action
FDA, EMA, or MFDS approval, filing, or complete response letter.

Recent Trial Readouts & Regulatory Updates

Every entry separates a plain-language summary (What happened) from trial methodology and effect-size estimands (For clinicians). Specific study doses appear only inside the collapsed Study details box. It is not medical or dosing advice.

Retatrutide lowered weight and blood sugar in a large trial of adults with type 2 diabetes (TRIUMPH-2)

What happened (Plain English)

Retatrutide is an experimental weekly shot that acts on three hormone signals affecting hunger and blood sugar (GIP, GLP-1, and glucagon). In a study called TRIUMPH-2, about 1,150 adults with type 2 diabetes and excess weight received either retatrutide or a placebo (a shot with no active drug) for about a year and a half (80 weeks).

People on the two higher dose arms lost about 17% to 19% of their body weight on average, compared with about 5% on placebo. Blood sugar also improved. Stomach side effects like diarrhea and nausea were common, and more people on the drug stopped treatment because of side effects than people on placebo. Results were published in The Lancet on September 29, 2026. Eli Lilly says it plans to ask the FDA for approval in early 2027.

For clinicians & researchers

  • Design: Phase 3, double-blind, placebo-controlled, parallel-group RCT across 92 sites in 8 countries (NCT05929079).
  • Population: n = 1,152 adults; BMI ≥27 kg/m² with T2D (HbA1c 6.5–10.5%) on diet/exercise alone or up to 3 oral glucose-lowering agents. Mean baseline BMI 38.2 kg/m², mean HbA1c 7.71%.
  • Primary endpoint: Percent body-weight change at week 80 for the middle and high maintenance arms vs. placebo (low maintenance arm vs. placebo was a key secondary endpoint).
  • Effect sizes (treatment-regimen estimand): −11.9% (low arm), −16.8% (middle arm), and −18.8% (high arm) vs. −5.1% placebo. Estimated treatment difference (ETD) vs. placebo: −6.9% (95% CI −8.7 to −5.1), −11.8% (−13.7 to −9.8), and −13.8% (−15.8 to −11.8); p < 0.0001 for all. Lilly’s press release highlights larger figures for the two higher arms (19.1% and 20.8%) from the efficacy estimand, which assumes full adherence. Use the treatment-regimen numbers when comparing across trials.
  • Safety: Diarrhea 27–34% vs. 13% placebo; nausea 14–28% vs. 8%; hypotension 1–6% vs. <1%; dysesthesia 4–7% vs. 1%. Discontinuation due to adverse events or death: 4% (low arm), 12% (middle arm), 8% (high arm) vs. 5% placebo. Deaths: 2 / 3 / 1 vs. 1 placebo, all judged unrelated by investigators.
  • Caveats: Funded by Eli Lilly and Company; comparator was placebo rather than an active incretin; 80 weeks does not establish cardiovascular or renal outcome benefit; dysesthesia mechanism remains under characterization. Related publications: TRIUMPH-1 in obesity without diabetes (NEJM, Sep 29) and TRIUMPH-1/2 OSA substudies (NEJM, Oct 21).
Study details (trial arms & schedule — not dosing advice)

Once-weekly subcutaneous retatrutide randomized 1:1:1:1 across 4 mg, 9 mg, or 12 mg maintenance arms vs. matched placebo for 80 weeks (self-administered). Reported strictly as published clinical trial methodology.

What we don’t know yet:
  • Whether weight loss holds past 80 weeks and the trajectory of weight regain after discontinuation.
  • Hard cardiovascular, kidney, or mortality outcomes (no dedicated outcomes readout yet).
  • Head-to-head comparison against tirzepatide (TRIUMPH-5, NCT06662383 has an estimated primary completion of Nov 2026).
  • What causes the nerve-sensation side effects (dysesthesia) and how quickly they resolve.
Primary sources:
  1. Bellido V, et al. Lancet 2026;408:1455–1472. PMID 42810372
  2. ClinicalTrials.gov NCT05929079
  3. Eli Lilly press release (Sep 29, 2026)

This summary reports research findings. It is not medical advice. Talk with a licensed clinician about any treatment decision.

Survodutide Phase 3 results in adults with obesity and type 2 diabetes published (SYNCHRONIZE-2)

What happened (Plain English)

Survodutide is an experimental weekly shot from Boehringer Ingelheim (licensed from Zealand Pharma) that acts on two hormone signals (GLP-1 and glucagon). In the SYNCHRONIZE-2 study, 755 adults with type 2 diabetes and excess weight took survodutide or a placebo for 76 weeks.

Counting everyone randomized—including people who stopped taking the drug early—the survodutide groups lost about 8% to 10% of their body weight, compared with about 4% on placebo. Blood sugar improved as well. However, stomach side effects were common, and nearly 1 in 5 people on survodutide (18%) stopped treatment because of gastrointestinal side effects (versus 1.2% on placebo). Results were presented at EASD in Milan and published in the New England Journal of Medicine on October 1, 2026.

For clinicians & researchers

  • Design: Phase 3, multinational, double-blind, placebo-controlled RCT (NCT06066528).
  • Population: n = 752 analyzed (755 randomized); T2D with BMI ≥27 kg/m². Mean age 55.7 years, mean BMI 36.5 kg/m², baseline HbA1c 7.4%.
  • Co-primary endpoints: Percent body-weight change and achievement of ≥5% weight loss at week 76.
  • Effect sizes (treatment-regimen estimand, NEJM): Weight change of −8.2% (95% CI −9.2 to −7.2; lower maintenance arm) and −9.8% (−10.8 to −8.8; higher maintenance arm) vs. −3.9% (−4.9 to −2.9) with placebo. Proportion achieving ≥5% weight loss: 57.6% and 64.5% vs. 35.1% (P < 0.001). HbA1c change: −0.9 and −0.8 vs. −0.2 percentage points.
  • Sponsor’s efficacy-estimand figures (press release, on-treatment): Weight change up to −13.1% vs. −3.1%; ≥5% weight loss in 79.3% vs. 32.7%; HbA1c −1.21 vs. −0.03 percentage points.
  • Safety & caveats: GI adverse events occurred in 72.8% and 77.7% vs. 38.6% placebo. Discontinuation due to GI AEs was 18% vs. 1.2% (mainly during rigid protocol dose escalation). Notice the 3.3-percentage-point gap between the efficacy and treatment-regimen estimands driven by early GI discontinuations, and that the higher arm did not reduce HbA1c more than the lower arm. Funded by Boehringer Ingelheim.
Study details (trial arms & schedule — not dosing advice)

Once-weekly subcutaneous survodutide randomized 1:1:1 to 3.6 mg or 6.0 mg maintenance arms vs. placebo for 76 weeks. Reported strictly as published clinical trial methodology.

What we don’t know yet:
  • Results of the cardiovascular outcomes trial SYNCHRONIZE-CVOT (NCT06077864, n = 5,531), guided by the sponsor for “later this year.”
  • Whether slower or more flexible dose-escalation schedules reduce the 18% GI dropout rate.
  • Regulatory filing timeline (no NDA/MAA submission announced yet).
Primary sources:
  1. Wharton S, et al. N Engl J Med 2026. doi:10.1056/NEJMoa2607219 (PMID 42820639)
  2. ClinicalTrials.gov NCT06066528
  3. Boehringer Ingelheim press release (Oct 1, 2026)

This summary reports research findings. It is not medical advice. Talk with a licensed clinician about any treatment decision.

Zealand Pharma reports Phase 2 petrelintide topline results in type 2 diabetes (ZUPREME-2)

What happened (Plain English)

Petrelintide is an experimental weekly shot that mimics amylin, a pancreatic hormone that slows stomach emptying and helps people feel full. On October 7, 2026, Zealand Pharma announced early (“topline”) results from ZUPREME-2, a 28-week mid-stage study in 220 adults in the U.S. with type 2 diabetes and excess weight.

In the company’s words, “Petrelintide achieved up to 9.2% mean body weight reduction at week 28 versus 2.0% with placebo.” The company also reported lower blood sugar and stated that discontinuation rates due to stomach side effects were “1.9% for petrelintide versus 1.7% in placebo group.” Zealand says full results will be presented at an upcoming scientific conference.

For clinicians & researchers

  • Design: Phase 2b, randomized, double-blind, placebo-controlled, U.S. multicenter trial (NCT06926842). Background therapy was metformin ± SGLT2 inhibitor plus a lifestyle program.
  • Population: n = 220 (registry enrollment: 221). Mean baseline BMI 36.3 kg/m², mean HbA1c 8.0%.
  • Primary endpoint: Percent body-weight change from baseline at week 28.
  • Effect sizes (sponsor’s words, efficacy estimand): Weight: “up to 9.2% mean weight loss from baseline using the efficacy estimand (range across treatment arms: 7.4–9.2%), compared to 2.0% with placebo, with results remaining largely consistent under the treatment regimen estimand.” Exact treatment-regimen point estimates and 95% confidence intervals were not disclosed in the release. HbA1c: “a placebo-adjusted HbA1c reduction of 0.61%–0.88%.”
  • Safety (sponsor’s words): “No unexpected safety signals were observed.” Discontinuation due to GI adverse events was “1.9% for participants treated with petrelintide versus 1.7% with placebo,” with GI AEs described as mostly mild during dose escalation.
  • Caveats & context: Sponsor topline release only (no confidence intervals, per-arm dose breakdown, or full AE tables yet; 28-week duration). For peer-reviewed context, ZUPREME-1 (obesity without diabetes, n = 485 dosed) was published September 29, 2026 in Lancet Diabetes & Endocrinology (PMID 42810355), reporting week-28 ETDs of −6.2% to −8.1% vs. placebo and nausea in 20% vs. 6%.
Study details (trial arms & schedule — not dosing advice)

Three once-weekly subcutaneous petrelintide dose arms (escalated every 4 weeks over up to 16 weeks, followed by maintenance through week 28) vs. placebo. Specific mg maintenance doses per arm were not disclosed in the topline announcement. Reported strictly as published clinical trial methodology.

What we don’t know yet:
  • Full peer-reviewed results, including treatment-regimen numbers, 95% confidence intervals, results by dose arm, and complete adverse-event tables.
  • Whether weight loss continues beyond 28 weeks in people with type 2 diabetes.
  • Phase 3 outcomes (ZUPREME-3, -4, and -5 enrolling ~7,000 participants total).
Primary sources:
  1. Zealand Pharma Company Announcement No. 54/2026 (Oct 7, 2026)
  2. ClinicalTrials.gov NCT06926842
  3. Garvey WT, et al. Lancet Diabetes Endocrinol 2026;14:914–926 (ZUPREME-1, PMID 42810355)

This summary reports research findings. It is not medical advice. Talk with a licensed clinician about any treatment decision.

Footnote: These results come from the sponsor’s announcement. The full paper hasn’t been released yet, so while the early data are encouraging, we’re holding some caution until we’ve reviewed it. We’ll update this entry when it’s published.

Trial Readout & Regulatory Decision Calendar (40 Tracked Events)

Covers 10 recent readouts (Sep–Oct 2026) and 30 upcoming regulatory decisions, sponsor-guided readouts, and ClinicalTrials.gov primary completion dates through April 2027.

Open Datasets (CC BY 4.0): Download CSV · Download JSON
How to read the date column: PDUFA date announced by sponsor = a specific FDA goal date the company has published. Sponsor guidance = the company’s own forecast (a quarter or half-year); it can slip. CT.gov registry estimate = the date the sponsor expects to finish collecting primary-endpoint data on ClinicalTrials.gov; public results are typically announced weeks to months later. Estimate = calculated from a regulator’s standard timeline (e.g., European Commission decision ~67 days after positive CHMP opinion). Unknown = no public date found (we never guess unannounced dates).

Showing all 40 tracked events.

ID Compound & Sponsor Trial / Program & Indication What’s Measured Date & Source Type Status Primary Sources
R01 Retatrutide
Eli Lilly · Phase: 3
NCT05929079 (TRIUMPH-2)
Obesity/overweight with type 2 diabetes
% body-weight change at week 80 (two higher dose arms vs placebo) Read entry ↓ 2026-09-29 (Lancet online + Lilly press release)
peer-reviewed + sponsor press release
Reported Lancet PMID 42810372 Source 3 NCT05929079
R02 Retatrutide
Eli Lilly · Phase: 3
NCT05929066 (TRIUMPH-1)
Obesity/overweight without diabetes
% body-weight change at week 80 Read entry ↓ 2026-09-29 (NEJM full publication; topline was announced earlier in 2026)
peer-reviewed
Reported PMID 42814954 NEJM NCT05929066
R03 Retatrutide
Eli Lilly · Phase: 3
NCT05929066, NCT05929079 (TRIUMPH-1-OSA / TRIUMPH-2-OSA substudies)
Moderate-to-severe obstructive sleep apnea with obesity/overweight
Change in apnea-hypopnea index (AHI) at week 80 Read entry ↓ 2026-10-21 (NEJM online)
peer-reviewed
Reported PMID 42904878 NEJM
R04 Survodutide
Boehringer Ingelheim (licensed from Zealand) · Phase: 3
NCT06066528 (SYNCHRONIZE-2)
Obesity/overweight with type 2 diabetes
Co-primary: % body-weight change and ≥5% weight loss at week 76 Read entry ↓ 2026-10-01 (EASD + NEJM)
peer-reviewed + sponsor press release
Reported PMID 42820639 NEJM Source 3 NCT06066528
R05 Petrelintide
Zealand Pharma / Roche · Phase: 2b
NCT06926842 (ZUPREME-2)
Overweight/obesity with type 2 diabetes
% body-weight change at week 28 Read entry ↓ 2026-10-07 topline; full data 'at an upcoming scientific conference' (date unknown)
sponsor press release (topline only, not peer-reviewed)
Reported (topline) Source 1 NCT06926842
R06 Petrelintide
Zealand Pharma · Phase: 2
NCT06662539 (ZUPREME-1)
Obesity/overweight without diabetes
% body-weight change at week 28 (42-week trial) Read entry ↓ 2026-09-29 (Lancet Diabetes Endocrinol online)
peer-reviewed
Reported PMID 42810355 Source 2
R07 Efpeglenatide
Hanmi Pharmaceutical · Phase: 3 → approval
Korean phase 3 (448 participants, 40-week interim topline per Hanmi); registry ID not confirmed in this pass
Chronic weight management (Korea)
Regulatory decision: Korea MFDS marketing authorisation 2026-10-07 (MFDS approval)
sponsor press release + KRX disclosure
Approved (Korea) Source 1 KRX Filing
R08 Icotrokinra
Johnson & Johnson · Phase: 3
NCT06878404 (ICONIC-PsA 1)
Active psoriatic arthritis, biologic-naive (not an approved use)
ACR20 at week 16 2026-10-20 abstract published; poster LB session 2026-11-10 (ACR Convergence)
conference abstract + sponsor press release
Reported (abstract); presentation upcoming ACR Abstract Source 2 NCT06878404
R09 CagriSema (cagrilintide + semaglutide)
Novo Nordisk · Phase: 3 (post hoc)
REDEFINE 1 (post hoc analyses in women)
Obesity/overweight, women by menopause stage
% body-weight change at week 68 (post hoc, efficacy estimand) 2026-10-20 (Menopause Society poster + Novo press release)
conference poster + sponsor press release
Reported (post hoc, hypothesis-generating) Source 1
R10 Enicepatide (CT-388)
Roche (Carmot) · Phase: 2
NCT06628362 (CT-388-104)
Type 2 diabetes with overweight/obesity
HbA1c and % body-weight change (Roche: week 48; registry lists week 36 — discrepancy) 2026-09-22 topline
sponsor press release (topline)
Reported (topline) Source 1 NCT06628362
U01 CagriSema (cagrilintide + semaglutide)
Novo Nordisk · Phase: NDA
REDEFINE program (NDA filed Dec 2025)
Chronic weight management
FDA decision on NDA Q4 2026 (exact PDUFA date not public)
sponsor guidance
Awaiting regulatory decision Source 1 Source 2 Source 3
U02 Glepaglutide (Zeydovio)
Zealand Pharma · Phase: MAA
EASE program (EU MAA)
Short bowel syndrome, adults (EU)
European Commission decision after positive CHMP opinion (17 Sep 2026) ~2026-11-23 (estimate: EC decisions are 'normally' issued 67 days after CHMP opinion)
estimate from EMA standard timeline
Awaiting regulatory decision EMA Source 2
U03 Semaglutide (higher-dose oral Ozempic tablets)
Novo Nordisk · Phase: sNDA
Supplemental application (T2D)
Type 2 diabetes (higher oral dose)
FDA decision on supplemental application By end of 2026 (no public PDUFA date)
sponsor guidance
Awaiting regulatory decision Source 1 Source 2
U04 Vosoritide (Voxzogo)
BioMarin · Phase: sNDA
Studies 111-205, 111-208, 111-302 (long-term data)
Achondroplasia — conversion from accelerated to full approval
FDA action on sNDA 2027-02-28 (PDUFA target action date)
PDUFA date announced by sponsor
Awaiting regulatory decision Source 1
U05 Vosoritide (Voxzogo)
BioMarin · Phase: sNDA
NCT06455059 (CANOPY-HCH-3)
Hypochondroplasia (not approved anywhere)
FDA review of sNDA submitted ~Sep 2026 unknown (no PDUFA date published by sponsor; sponsor cites 'potential 2027 launch')
unknown
Under review (filing acceptance not yet announced) Source 1 NCT06455059
U06 Avexitide
Amylyx · Phase: NDA planned
NCT06747468 (LUCIDITY)
Post-bariatric hypoglycemia
NDA submission to FDA By end of 2026
sponsor guidance
Filing planned Source 1 NCT06747468
U07 Dasiglucagon
Zealand Pharma · Phase: NDA resubmission planned
Phase 3 CHI program (NDA resubmission)
Congenital hyperinsulinism
NDA resubmission to FDA (3-week and >3-week use) H2 2026
sponsor guidance
Filing planned Source 1
U08 Retatrutide
Eli Lilly · Phase: BLA planned
TRIUMPH program
Obesity (incl. with T2D)
BLA submission to FDA Q1 2027
sponsor guidance
Filing planned Source 1
U09 Orforglipron (Foundayo)
Eli Lilly · Phase: NDA (new indication)
ACHIEVE program
Type 2 diabetes (approved in US for weight management only)
FDA decision unknown (filed Q2 2026 per Lilly Q2 update; no decision date public)
unknown
Under review Source 1
U10 Apitegromab (Isembyld)
Scholar Rock · Phase: MAA
SAPPHIRE (EU MAA resubmitted 2026-10-08)
Spinal muscular atrophy (EU)
CHMP opinion H1 2027
sponsor guidance
Awaiting regulatory decision Source 1 Source 2
U11 Survodutide
Boehringer Ingelheim · Phase: 3
NCT06077864 (SYNCHRONIZE-CVOT)
Overweight/obesity with CV disease, CKD or CV risk factors
Time to first adjudicated composite CV event (CV safety) 'Later this year' (2026); registry primary completion 2026-06-01 (actual)
sponsor guidance
Upcoming readout Source 1 NCT06077864
U12 Efruxifermin
Novo Nordisk (via Akero) · Phase: 3
NCT06161571 (SYNCHRONY Real-World)
MASH/MASLD F1–F4 (non-invasively diagnosed)
Safety and tolerability over 52 weeks Q4 2026
sponsor guidance
Upcoming readout Source 1 NCT06161571
U13 Taldefgrobep alfa
Biohaven · Phase: 2
NCT07281495
Overweight/obesity
% body-weight change at week 24 (plus body-composition goals per sponsor) 2H 2026
sponsor guidance
Upcoming readout SEC 8-K NCT07281495
U14 Efruxifermin
Novo Nordisk (via Akero) · Phase: 3
NCT06215716 (SYNCHRONY Histology)
MASH, fibrosis F2–F3
Week-52 fibrosis improvement + MASH resolution (cohort 1); event-free survival at 240 weeks unknown (pre-acquisition Akero guidance of 1H 2027 not reconfirmed by Novo; registry primary completion 2033-02 est.)
unknown
Ongoing NCT06215716 Source 2
U15 Retatrutide
Eli Lilly · Phase: 3
NCT06662383 (TRIUMPH-5)
Obesity — head-to-head vs tirzepatide
% body-weight change at week 80 2026-11 (est. primary completion)
CT.gov registry estimate
Upcoming primary completion NCT06662383
U16 Retatrutide
Eli Lilly · Phase: 3
NCT06297603 (TRANSCEND-T2D-3)
Type 2 diabetes with moderate/severe renal impairment
HbA1c change at week 52 2026-10 (est. primary completion)
CT.gov registry estimate
Upcoming primary completion (Registry status: Active, not recruiting; last updated 2026-07-20 — estimate not revised since July, so date may slip; no readout announced yet) NCT06297603
U17 Tirzepatide
Eli Lilly · Phase: 3
NCT06914895 (SURPASS-T1D-1)
Type 1 diabetes with obesity/overweight
HbA1c change at week 40 2026-11 (est. primary completion)
CT.gov registry estimate
Upcoming primary completion NCT06914895
U18 Tirzepatide
Eli Lilly · Phase: 3
NCT06962280 (SURPASS-T1D-2)
Type 1 diabetes with obesity/overweight (long-term)
HbA1c change at week 40 2026-11 (est. primary completion)
CT.gov registry estimate
Upcoming primary completion NCT06962280
U19 MariTide (maridebart cafraglutide)
Amgen · Phase: 3
NCT06858839 (MARITIME-1)
Obesity/overweight without T2D
% body-weight change at week 72 2027-01-21 (est. primary completion)
CT.gov registry estimate
Upcoming primary completion NCT06858839
U20 MariTide (maridebart cafraglutide)
Amgen · Phase: 3
NCT06858878 (MARITIME-2)
Obesity/overweight with T2D
% body-weight change at week 72 2027-01-21 (est. primary completion)
CT.gov registry estimate
Upcoming primary completion NCT06858878
U21 Mazdutide
Innovent Biologics · Phase: 3
NCT06884293
Overweight/obesity with MASLD (China), vs semaglutide
% body-weight change and liver-fat change at week 48 2026-12-31 (est. primary completion)
CT.gov registry estimate
Upcoming primary completion NCT06884293
U22 CagriSema (cagrilintide + semaglutide)
Novo Nordisk · Phase: 3
NCT07011667
Obesity — weight loss and maintenance
Relative body-weight change, week 0 to 80 2027-03-01 (est. primary completion)
CT.gov registry estimate
Upcoming primary completion NCT07011667
U23 Icotrokinra
Johnson & Johnson · Phase: 3
NCT06807424 (ICONIC-PsA 2)
Active psoriatic arthritis (biologic-experienced and naive)
ACR20 at week 16 2027-02-10 (est. primary completion)
CT.gov registry estimate
Upcoming primary completion NCT06807424
U24 Eloralintide
Eli Lilly · Phase: 2
NCT07215559
Obesity/overweight — eloralintide and macupatide alone or combined
% body-weight change at week 32 2027-03 (est. primary completion)
CT.gov registry estimate
Upcoming primary completion NCT07215559
U25 Setmelanotide
Rhythm Pharmaceuticals · Phase: 2
NCT06772597
Prader-Willi syndrome
Frequency/severity of adverse events to week 52 2026-10-31 (est. primary completion)
CT.gov registry estimate
Upcoming primary completion NCT06772597
U26 Setmelanotide
Rhythm Pharmaceuticals · Phase: 3
NCT06760546
Congenital hypothalamic obesity (substudy)
Mean % change in BMI after 26 weeks 2027-03-13 (est. primary completion)
CT.gov registry estimate
Upcoming primary completion NCT06760546
U27 Octreotide (subcutaneous depot, CAM2029)
Camurus · Phase: 3
NCT05050942 (SORENTO)
Gastroenteropancreatic neuroendocrine tumours
Progression-free survival (blinded central review) 2026-11 (est. primary completion; event-driven)
CT.gov registry estimate
Upcoming primary completion NCT05050942
U28 Pasireotide
Recordati · Phase: 2
NCT05928390 (PASIPHY)
Post-bariatric hypoglycaemia
Blood glucose during mixed-meal test at 12 weeks 2026-10-29 (est. primary completion)
CT.gov registry estimate
Upcoming primary completion (Registry status: Active, not recruiting; last updated 2026-09-17) NCT05928390
U29 Vosoritide (Voxzogo)
BioMarin · Phase: 2
NCT06668805
Noonan syndrome with inadequate growth after growth hormone
Change in annualized growth velocity at 6 months 2027-03 (est. primary completion)
CT.gov registry estimate
Upcoming primary completion NCT06668805
U30 Apitegromab (Isembyld)
Scholar Rock · Phase: 3 (extension)
NCT05626855 (ONYX)
SMA types 2 and 3, long-term extension
Long-term safety and tolerability (up to 6 years) 2026-11-01 (est. primary completion)
CT.gov registry estimate
Upcoming primary completion NCT05626855
Editorial Rules, Registry Integrity & Known Calendar Gaps

1. Primary source or it doesn’t run: Every number traces to a peer-reviewed paper, ClinicalTrials.gov/EU CTR record, FDA/EMA/MFDS document, SEC filing, or the sponsor’s official release. Third-party PDUFA aggregators are never cited as the source of a date.

2. Sponsor topline releases: Topline announcements are published at Evidence Level C using the company’s exact quoted figures, noting which estimand was reported, and carrying a footnote that the full peer-reviewed paper is not yet available. When the peer-reviewed paper appears, the same entry is updated in place with a dated What changed note.

3. Registry integrity: Known mock or unverified registry records are permanently excluded.

4. Known gaps in the current Oct 2026 – Apr 2027 window:

  • No public exact PDUFA date has been disclosed for CagriSema (guided Q4 2026), higher-dose oral semaglutide in T2D (guided by end of 2026), orforglipron in T2D, or vosoritide in hypochondroplasia.
  • For enicepatide (CT-388), Roche’s September 2026 release reports week-48 primary endpoints while ClinicalTrials.gov (NCT06628362) lists week 36; flagged until the full presentation resolves the discrepancy.
  • Major trials outside the April 2027 window (tracked on their compound pages): VK2735 VANQUISH Phase 3 (2H 2027), amycretin Phase 3 (2028), NNZ-2591 (Oct 2027), elamipretide (SS-31) ReNEW (Aug 2027), and pegozafermin (2028+).

5. Corrections log: Any factual correction is logged in place with a dated note. Found an error or a newer primary source? Email [email protected].