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topline; full data 'at an upcoming scientific conference' (date unknown) sponsor press release (topline only, not peer-reviewed) |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 |