While the FDA has already approved 11 novel drugs in 2026, some of the year's most anticipated decisions are still ahead. PDUFA (Prescription Drug User Fee Act) dates represent the FDA's target action date for each pending drug application — essentially the deadline by which the agency must approve, reject, or issue a Complete Response Letter for a new drug.
Below is our tracker of the most significant remaining PDUFA dates in 2026. We focus on drugs with the broadest patient impact, the most commercial interest, or the most innovative mechanisms of action.
Last updated: April 9, 2026. PDUFA dates are subject to change if the FDA extends its review timeline.
2026 PDUFA Dates at a Glance
| Drug / Candidate | Generic Name | PDUFA Date | Manufacturer | Indication | Why It Matters |
|---|---|---|---|---|---|
| CagriSema | cagrilintide + semaglutide | Q2 2026 (est.) | Novo Nordisk | Obesity / Weight management | Dual GLP-1/amylin could set new weight-loss record |
| Survodutide | survodutide | Q3 2026 (est.) | Boehringer Ingelheim | Obesity / MASH | Dual GLP-1/glucagon agonist for weight + liver |
| Retatrutide | retatrutide | Late 2026 / Early 2027 (est.) | Eli Lilly | Obesity / Type 2 diabetes | Triple agonist (GIP/GLP-1/glucagon) with ~24% weight loss |
| Pivlicaftor triple | vanzacaftor/tezacaftor/pivlicaftor | Q3 2026 (est.) | Vertex Pharmaceuticals | Cystic fibrosis | Next-gen CFTR modulator, potential Trikafta successor |
| Relutrigine | relutrigine | Sep 27, 2026 | Xenon Pharmaceuticals / Neurocrine | Epilepsy (focal seizures) | First selective Nav1.6 sodium channel inhibitor |
CagriSema (Cagrilintide + Semaglutide)
Overview
Manufacturer: Novo Nordisk
Indication: Chronic weight management in adults with obesity or overweight with comorbidities
Estimated PDUFA: Q2 2026
CagriSema combines two mechanisms in a single injection: cagrilintide (a long-acting amylin analog) and semaglutide 2.4 mg (the same GLP-1 used in Wegovy). The theory is that dual-pathway appetite suppression will produce greater weight loss than either component alone.
Clinical Data
The REDEFINE Phase 3 program demonstrated approximately 22–25% body weight loss in completers at 68 weeks — making CagriSema potentially the most effective anti-obesity medication ever approved. In head-to-head comparisons with semaglutide 2.4 mg alone, CagriSema produced statistically superior weight loss.
Why It Matters
If approved, CagriSema would become the benchmark for obesity pharmacotherapy. It also represents Novo Nordisk's strategy to maintain dominance in the weight-loss market as competition from tirzepatide (Zepbound) and oral GLP-1s intensifies. The main question is whether the added complexity and cost of a dual-mechanism injection justify the incremental efficacy over semaglutide alone.
Survodutide
Overview
Manufacturer: Boehringer Ingelheim (in collaboration with Zealand Pharma)
Indication: Obesity and metabolic dysfunction-associated steatohepatitis (MASH, formerly NASH)
Estimated PDUFA: Q3 2026
Survodutide is a dual GLP-1 and glucagon receptor agonist. While GLP-1 agonism reduces appetite and food intake, the glucagon component increases energy expenditure and promotes hepatic fat mobilization — making survodutide particularly attractive for patients with both obesity and fatty liver disease.
Clinical Data
In the ACHIEVE Phase 3 program for MASH, survodutide demonstrated significant reductions in liver fat content and histological improvement in fibrosis scores. For obesity, weight loss of approximately 18–20% was observed in completers, placing it competitively between semaglutide 2.4 mg and CagriSema.
Why It Matters
Survodutide addresses a massive unmet need: the intersection of obesity and liver disease. MASH affects an estimated 6–8 million Americans and currently has only one FDA-approved treatment (resmetirom/Rezdiffra). An obesity drug that simultaneously treats liver disease could simplify regimens for millions of patients.
Retatrutide
Overview
Manufacturer: Eli Lilly
Indication: Obesity and type 2 diabetes
Estimated PDUFA: Late 2026 or early 2027 (NDA filing expected mid-2026)
Retatrutide is a triple-hormone receptor agonist targeting GIP, GLP-1, and glucagon receptors simultaneously. It is Eli Lilly's next-generation anti-obesity candidate, designed to succeed tirzepatide (Zepbound/Mounjaro) by adding glucagon receptor agonism for enhanced energy expenditure and fat oxidation.
Clinical Data
The Phase 2 trial data for retatrutide was jaw-dropping: approximately 24% body weight loss at the highest dose at 48 weeks — the most weight loss ever seen in a clinical trial for an anti-obesity medication. Phase 3 data from the TRIUMPH program is expected in mid-2026.
Why It Matters
If Phase 3 confirms Phase 2 results, retatrutide would be the most efficacious anti-obesity drug available, potentially rivaling bariatric surgery outcomes in a weekly injection. Eli Lilly is positioning it as the next evolution beyond Zepbound, though the approval timeline may push into 2027.
Vanzacaftor/Tezacaftor/Pivlicaftor (Vertex Triple)
Overview
Manufacturer: Vertex Pharmaceuticals
Indication: Cystic fibrosis (CF) in patients aged 6 years and older with at least one F508del allele
Estimated PDUFA: Q3 2026
This next-generation CFTR modulator triple combination is designed as a successor to Trikafta (elexacaftor/tezacaftor/ivacaftor), the current standard of care for most CF patients. The new combination replaces elexacaftor with vanzacaftor and adds pivlicaftor, aiming for improved CFTR protein correction and once-daily dosing.
Clinical Data
In Phase 3 trials, the vanzacaftor triple demonstrated improvements in lung function (ppFEV1) that were non-inferior to Trikafta, with the advantage of once-daily dosing (vs. Trikafta's twice-daily regimen). Additionally, the new combination expanded the proportion of CF genotypes responsive to CFTR modulator therapy.
Why It Matters
While Trikafta was a transformative drug for CF, compliance with twice-daily dosing remains a challenge, particularly for pediatric patients. A once-daily option that matches or exceeds Trikafta's efficacy would meaningfully improve quality of life. Vertex essentially competing against itself to maintain the CF franchise demonstrates how rapidly CF therapeutics are advancing.
Relutrigine
Overview
Manufacturer: Xenon Pharmaceuticals / Neurocrine Biosciences
Indication: Focal onset seizures in adults with epilepsy
PDUFA Date: September 27, 2026
Relutrigine is a first-in-class selective Nav1.6 sodium channel inhibitor. Unlike older sodium channel blockers (carbamazepine, lacosamide, phenytoin) which broadly inhibit multiple sodium channel subtypes — including Nav1.5 in the heart — relutrigine selectively targets Nav1.6, the primary excitatory sodium channel in the brain. This selectivity is designed to preserve anti-seizure efficacy while reducing cardiac, sedative, and cognitive side effects.
Clinical Data
In the Phase 3 X-TOLE trial, relutrigine demonstrated a statistically significant reduction in focal seizure frequency compared to placebo when added to existing anti-seizure medications. The drug was well tolerated, with the most common side effects being dizziness and somnolence at rates comparable to or lower than existing sodium channel blockers.
Why It Matters
Epilepsy affects approximately 3.4 million Americans, and roughly one-third of patients have drug-resistant seizures. Relutrigine's selective mechanism represents the first truly novel approach to sodium channel modulation in decades. If approved, it would be the first new mechanism-of-action anti-seizure medication since cenobamate (Xcopri) in 2019.
Other Notable Decisions Expected in 2026
Beyond the five candidates highlighted above, several other drugs are expected to reach PDUFA decisions in 2026:
- Duvakitug — anti-TL1A antibody for inflammatory bowel disease (Merck/Dr. Reddy's)
- Cobenfy (xanomeline/trospium) — already approved for schizophrenia, supplemental application for bipolar I disorder
- Pirtobrutinib — BTK inhibitor for previously treated chronic lymphocytic leukemia (Eli Lilly)
- Lunresertib — ATR inhibitor for ovarian cancer (AstraZeneca)
We will add PDUFA dates for these candidates as they are confirmed by the FDA.
How PDUFA Dates Work
For those unfamiliar with the process:
- A PDUFA date is the FDA's self-imposed deadline to act on a New Drug Application (NDA) or Biologics License Application (BLA)
- Standard reviews have a 10-month PDUFA date from filing; Priority Reviews have a 6-month PDUFA date
- The FDA can take action before the PDUFA date (early approval) or extend the review by 3 months if it requests additional information
- On the PDUFA date, the FDA may approve, issue a Complete Response Letter (CRL) requesting more data, or, rarely, refuse to file the application
PDUFA dates are not guarantees of approval, but they represent the FDA's commitment to timely review. Historically, drugs that reach PDUFA dates after completing Phase 3 programs are approved the majority of the time.
The Bottom Line
2026 has the potential to be a banner year for drug approvals. The remaining PDUFA calendar includes several potentially transformative therapies — from CagriSema's unprecedented weight-loss efficacy to relutrigine's novel approach to seizure control. Patients and prescribers alike should follow these decisions closely.
Bookmark this page for regular updates. See also our complete tracker of 2026 FDA approvals for drugs already approved this year.
Sources
- FDA PDUFA date tracking databases and manufacturer SEC filings.
- REDEFINE (CagriSema), ACHIEVE (survodutide), TRIUMPH (retatrutide) clinical trial registrations.
- Vertex Pharmaceuticals investor presentations, 2026.
- Xenon Pharmaceuticals X-TOLE Phase 3 trial results.
- MedSwitcher editorial analysis, April 2026.