A small ring-shaped peptide, taken as a daily pill, that blocks the receptor for IL-23, an immune signal that drives psoriasis. Injected antibody drugs act on the same pathway.
Evidence. FDA-approved in March 2026 as Icotyde, then in Japan and the EU in September 2026, for moderate-to-severe plaque psoriasis in adults and in teens 12 and older weighing at least 40 kg; the first IL-23 pathway drug taken as a pill. In ICONIC-LEAD (684 people), 50% vs 4% on placebo reached PASI 90, a 90% improvement, at week 16. Phase 3 trials in psoriatic arthritis, ulcerative colitis and Crohn’s disease are under way.
What it’s used for
Approved uses first, then uses tested in people, then claims that rest on animal studies or user reports.
Plaque psoriasis
LabelApproved in 2026 (US, Japan, EU) for moderate-to-severe plaque psoriasis. In ICONIC-LEAD (684 people), 65% vs 8% on placebo had clear or almost clear skin at week 16.
Psoriasis of the scalp, genitals, hands, feet
LabelCovered by the approval. In ICONIC-TOTAL (311 people), the scalp cleared or nearly cleared in 65.9% vs 10.6% and the genitals in 76.5% vs 21.4%; hands and feet didn’t differ significantly.
Compared with deucravacitinib, another psoriasis pill
LabelIn two trials of 1,505 adults, more reached PASI 90 at week 24 on icotrokinra (65–66%) than on deucravacitinib (41–44%).
Pustular or erythrodermic psoriasis
LabelApproved in Japan only (September 2026) for these rare severe forms when other treatments fall short, after a small Japanese study of 19 people; not part of the US or EU approval.
Ulcerative colitis
TrialPromising, not approved: in a 12-week phase 2b trial of 252 adults, clinical response was 54.7–63.5% vs 27.0% on placebo, and remission 30.2% vs 11.1% at 400 mg. Reported only as an abstract.
Psoriatic arthritis
TrialUnproven so far: two phase 3 trials in about 1,300 adults are under way, and no results had been reported by October 2026.
Crohn’s disease
TrialUnproven: a phase 2b/3 trial in about 1,100 adults began in October 2025, with first results expected around 2028.
Label: an approved use. Trial: tested in people, with the result.
Approved in the US as Icotyde tablets (March 17, 2026) for moderate-to-severe plaque psoriasis in adults, and in children 12 and older weighing at least 40 kg, who are candidates for systemic therapy or phototherapy.
Approval history
2026US FDA: Icotyde: moderate-to-severe plaque psoriasis in adults and teens 12 and older
2026Japan (PMDA): Icotyde: plaque, pustular and erythrodermic psoriasis
2026EU (EMA): Icotyde: moderate-to-severe plaque psoriasis in adults and teens
European Union
Prescription only. Icotyde was authorized on September 18, 2026 for moderate-to-severe plaque psoriasis in adults and in teens 12 and older weighing at least 40 kg.
United Kingdom
No UK marketing authorization found: no Icotyde product information was listed as of October 8, 2026.
Canada
No marketing authorization yet: not in Health Canada’s drug database or approval notices (October 2026); a 2026 review reported it under review.
Australia
No marketing authorization: no TGA product information and no Poisons Standard entry (October 2026).
Sport (WADA 2026)
Not banned in sportNot named on the 2026 list, and S0 doesn’t apply to an approved drug. IL-23 blockers aren’t hormones, growth factors or metabolic modulators, so no prohibited class covers them.
Sport status follows the WADA Prohibited List in force since January 1, 2026; athletes should confirm with their anti-doping organization. Checked October 5, 2026. Status outside the US checked October 7, 2026 against EMA, MHRA, Health Canada and TGA records. By country: EU, UK, Canada, Australia. Status of every compound.
How it works
Icotrokinra binds the receptor for IL-23, an immune signaling protein, very tightly and stops IL-23 from attaching. IL-23 keeps a type of inflammatory T cell (Th17) active; blocking it lowered IL-17A, IL-17F, IL-22 and other signals that drive thick, scaly psoriasis plaques. Injected antibody drugs block the same pathway. Its ring shape and unusual building blocks help it survive digestion, yet under 1% of a dose is absorbed.
LabelBased on the product label.
Not known
The label says how these signal changes lead to clearer skin isn’t fully understood. Safety beyond about 2 years, including rare infections and cancer, is unknown.
Protocol
Label
Icotyde
Adults: 200 mg by mouth once a day on waking, on an empty stomach with water, at least 30 minutes before food. The EU label suggests stopping if there’s no benefit after 24 weeks.
Trial
FRONTIER 1, Bissonnette 2024
Phase 2 doses ran from 25 mg once daily to 100 mg twice daily; responses rose with dose (PASI 75 in 37–79% vs 9% on placebo at week 16).
Trial
ANTHEM-UC
Ulcerative colitis: 100, 200 or 400 mg once daily for 12 weeks in a phase 2b trial; not an approved use.
Frequency
Once daily
Route
Oral tablet (label)
Timing
On waking, on an empty stomach with water; no food for at least 30 minutes (a high-fat meal cut absorption by 43%).
Cycle
Continuous. The EU label suggests stopping if there’s no benefit by week 24. When responders stopped at week 24, most lost their response within months.
Week 15913172125
Continuous, shown over 26 weeks
Common protocols
The ways Icotrokinra is most often run, each tagged with where it comes from.
Label dose (Icotyde)
Label
Dose
200 mg
How often
Once daily, on waking, before food
How long
Long-term; the EU label reviews it at 24 weeks
Adults with moderate-to-severe plaque psoriasis who are candidates for whole-body treatment or light therapy. Can be dispersed in water if tablets are hard to swallow.
Phase 2 dose-finding (FRONTIER 1 and 2)
Trial
Dose
25 mg once daily to 100 mg twice daily
How often
Once or twice daily
How long
16 weeks, extended to 52
PASI 75 in 37–79% vs 9% on placebo at week 16, rising with dose; at week 52, 76% on 100 mg twice daily had PASI 75.
Ulcerative colitis (phase 2b, ANTHEM-UC)
Trial
Dose
100, 200 or 400 mg
How often
Once daily
How long
12 weeks, extended to 28
Clinical response 54.7–63.5% vs 27.0% on placebo; remission 30.2% vs 11.1% at 400 mg. Not approved for this; a phase 3 trial began in 2025.
Taking it
Where it goes
By mouth on waking, swallowed whole with water (not crushed, split or chewed), with no food for 30 minutes. Or dispersed in at least 120 mL of water and drunk within 15 minutes, then the cup refilled and drunk (label).
If you miss a dose
Icotyde label: take the missed dose as soon as possible that day, then return to the usual schedule the next day.
Itch improved by 4 points or more in about 1 in 5 (19–22% vs 5–7% on placebo).
Label
Week 16
In ICONIC-LEAD, 65% vs 8% on placebo had clear or almost clear skin, and 50% vs 4% reached PASI 90.
Label
Week 24
In ICONIC-ADVANCE 1, 74% had clear or almost clear skin vs 52% on deucravacitinib, another psoriasis pill; PASI 90 66% vs 41%.
Label
After stopping
Among week-24 responders switched to placebo, 21% kept PASI 90 at week 52 vs 84% who stayed on it; PASI 90 was lost after a median of about 10 weeks.
Label
Side effects and what to do
Headache (label: 4.1% vs 3.3% on placebo)
Usually mild.
Fungal infections such as athlete’s foot or thrush (label: 1.1% vs 0%)
Report itchy rashes, white patches in the mouth or other signs of a yeast infection.
Nausea 1.2% vs 0.5%, cough 1.2% vs 0.2%, fatigue 1.0% vs 0.5% (label)
Uncommon and usually mild in the trials.
Infections (serious: 0.2% vs 0.4% on placebo through week 16)
Report fever, cough or other signs of infection; the label says to stop it during a serious infection.
Antibodies to the drug (EU label: 12.2% by week 52, none neutralizing)
No effect on blood levels, safety or response was found through week 52.
Stop and get medical help
Fever, chills, a lasting cough or other signs of a serious infection, or symptoms of TB such as unexplained fever or trouble breathing: stop and contact the prescriber (label). Vomiting blood or black stools need emergency care.
Can it cause …?
The side effects people ask about most, answered one by one. Each answer says where it comes from.
Tiredness
LabelFatigue: 1.0% vs 0.5% on placebo in the 16-week trials of 1,864 people.
Headache
LabelHeadache: 4.1% vs 3.3% on placebo through week 16, the most common reaction in the US label.
Nausea or vomiting
LabelNausea: 1.2% vs 0.5% on placebo through week 16; gastritis and stomach discomfort occurred in under 1%.
Diarrhea or constipation
LabelDiarrhea and constipation aren’t listed. Gastritis and belly discomfort occurred in under 1%, and the EU label lists diverticulitis as uncommon.
Dizziness
Not reportedDizziness isn’t listed in the US or EU labels; 1,296 people took it in 16-week placebo-controlled trials, and 648 for a year or more.
Trouble sleeping
Not reportedTrouble sleeping isn’t listed in the US or EU labels, based on 1,296 people in 16-week placebo-controlled trials.
Hair loss
Not reportedHair loss isn’t listed in either label; 2,367 people took it in trials, 648 of them for at least a year.
Acne, rash or skin changes
LabelFungal infections, including athlete’s foot and tinea versicolor on the skin, were more common: 1.1% vs 0% overall. Its main effect on skin is clearing psoriasis.
Water retention or swelling
Not reportedSwelling isn’t listed in the US or EU labels, based on 16-week placebo-controlled trials in 1,296 people.
Joint or muscle pain
Not reportedJoint pain isn’t a listed side effect. Whether it helps psoriatic arthritis is being tested in phase 3 trials.
Anxiety, low mood or irritability
Not reportedMood changes aren’t listed in the US or EU labels, based on 16-week placebo-controlled trials in 1,296 people.
Low or high blood sugar
Not reportedBlood sugar changes aren’t listed in either label, based on 16-week placebo-controlled trials in 1,296 people.
Fast heartbeat or blood pressure changes
Not reportedHeart rate and blood pressure changes aren’t listed; at 5 times the dose it didn’t prolong the QT interval, a measure of heart rhythm.
More hunger
Not reportedAppetite changes aren’t listed in the US or EU labels, based on 16-week placebo-controlled trials in 1,296 people.
Liver strain
LabelNo liver effects are listed. The liver doesn’t break it down, and the EU label needs no dose change in liver impairment; severe impairment wasn’t studied.
Kidney problems
LabelNo kidney harm is listed. Blood levels rose about 2.5–2.8-fold in moderate or severe kidney impairment, so the US label advises watching for side effects.
Cancer risk
LabelNo tumors in a 2-year rat study or a 6-month mouse study. Trials have followed people for 1–2 years, too short to judge cancer risk.
Label: from the prescribing information. Not reported: studied in people and not reported. A side effect that hasn’t been reported can still happen, especially with long or high-dose use. Any of these across every compound: the side-effect finder.
Who should avoid it
What its label rules out or warns about, most important first.
Active serious infection
LabelThe EU label rules it out with clinically important active infections; the US label says not to start until an infection is treated and to stop during a serious one.
Active or latent tuberculosis
LabelThe US label advises considering TB testing first, treating latent TB when past treatment can’t be confirmed, and avoiding use with active TB.
Allergy to icotrokinra
LabelRuled out by the EU label (allergy to the drug or its ingredients); the US label lists no contraindications.
Anyone due a live vaccine
LabelLive vaccines are avoided during treatment and, per the EU label, for 3 days after stopping; other vaccinations are completed first. Vaccine responses haven’t been studied.
Pregnancy or breastfeeding
LabelHuman data are insufficient; very high doses caused pregnancy loss in rabbits. The EU label prefers to avoid it in pregnancy and to delay live vaccines in exposed newborns.
Moderate or severe kidney impairment
LabelBlood levels rose about 2.5–2.8-fold, so the US label advises watching for side effects; it hasn’t been studied in kidney failure on dialysis.
Children under 12 or under 40 kg
LabelNot studied; the approval covers teens 12 and older who weigh at least 40 kg.
Interactions
Only interactions stated on a product label or measured in a human study are listed.
Live vaccines (such as measles-mumps-rubella, chickenpox or yellow fever vaccines)
LabelDrugs that act on the immune system may raise the risk of infection from a live vaccine; the labels say to avoid them during treatment, and the EU label for 3 days after.
Other medicines in general
LabelNo formal interaction studies were done. In lab tests it didn’t block or induce liver CYP enzymes or the main drug transporters, so the labels expect no interactions.
Caffeine
LabelDidn’t change icotrokinra blood levels in a study (US label).
Label: a product label rules it out, warns about it or lists the interaction. This isn’t a complete list: a pharmacist or doctor can check a specific medicine or condition. Every documented interaction, by medicine: drug interactions.
Special situations
What the label and studies say about pregnancy, breastfeeding, kidney and liver problems, age and surgery.
Pregnancy
LabelData are insufficient. Rats showed no harm; rabbits at 157 times the human exposure had pregnancy loss and fused ribs. The EU label prefers to avoid it, and a pregnancy study is collecting outcomes.
Breastfeeding
LabelNo human data; in rats it reached nursing pups. The US label weighs benefits against risks, and the EU label asks for a choice between breastfeeding and treatment.
Kidney problems
LabelLevels rose 2.5–2.8-fold with moderate or severe kidney impairment. The US label advises watching for side effects when eGFR is under 60; the EU label lacks data in kidney failure on dialysis.
Liver problems
LabelNot studied in severe liver impairment. Because the liver doesn’t break it down, the labels expect little effect, and the EU label calls for no dose change.
Older adults
Label240 trial participants (10.1%) were 65 or older and 36 were 75 or older; no overall differences in safety or effect were seen.
Children and teens
LabelApproved for teens 12 and older who weigh at least 40 kg (US, EU); not studied in younger or lighter children. Vial Guide doesn’t show children’s doses.
Surgery and anesthesia
PrecautionNo label advice. It dampens one immune pathway, so tell the surgical team; whether to pause it around surgery hasn’t been studied.
Label: what the prescribing information says. Precaution: not studied, so the caution follows from how it works or from a related drug. Ages are given as approved or studied; this site never gives doses for children. Across every compound: pregnancy, breastfeeding, kidney disease, liver disease, older adults and surgery.
Tracking and pairing
Worth tracking
Signs of infection
TB screening before starting, by clinical judgment (US label)
Vaccinations completed before starting
Skin response by week 24 (EU label)
Often paired with
Usually run on its own.
Human studies
5 key published human studies, with how many people took part. Animal studies aren’t listed here.
2025684 people
Clear or almost clear skin in 65% vs 8%; PASI 90 in 50% vs 4%; completely clear skin (PASI 100) 27% vs under 1%; adverse events 49% in each group.
Design
Randomized double-blind placebo-controlled phase 3 trial (ICONIC-LEAD) in adults and teens 12 and older with moderate-to-severe plaque psoriasis
Dose
200 mg once daily
Length
16 weeks vs placebo, treatment through week 24
Bissonnette et al., N Engl J Med 2025, PMID 41191940
20251,505 people
PASI 90 at week 16 in 55% and 57% vs 4% and 1% on placebo; better than deucravacitinib in both trials (week 24 PASI 90 66% vs 41% in ADVANCE 1).
Design
Two randomized double-blind phase 3 trials vs placebo and deucravacitinib (ICONIC-ADVANCE 1 and 2)
Dose
200 mg once daily vs deucravacitinib 6 mg once daily
Length
16 weeks vs placebo, 24 weeks vs deucravacitinib
Stein Gold et al., Lancet 2025, PMID 40976249
2025311 people
Clear or almost clear overall in 56.7% vs 5.8%; scalp 65.9% vs 10.6%; genitals 76.5% vs 21.4%; hands and feet 41.7% vs 26.1% (not significant).
Design
Randomized double-blind placebo-controlled phase 3 trial (ICONIC-TOTAL) in psoriasis of the scalp, genitals, hands or feet
Dose
200 mg once daily
Length
16 weeks
Gooderham et al., NEJM Evid 2025, PMID 41191932
2024255 people
PASI 75 in 37–79% across doses vs 9% on placebo, rising with dose; adverse events 52% vs 51%.
Bissonnette et al., N Engl J Med 2024, PMID 38324484
20262,400 people
Through week 16, rates of adverse events, serious events and infections were similar to placebo; rates stayed steady through week 52 (serious events 4.6 per 100 person-years).
Design
Pooled safety analysis of the four phase 3 psoriasis trials
Dose
200 mg once daily
Length
Up to 52 weeks (1,840 person-years)
Lebwohl et al., Dermatol Ther (Heidelb) 2026, PMID 42663861
Registered trials that are still running, or that finished without published results, most important first. Checked on ClinicalTrials.gov, October 7, 2026.
Phase 3NCT06878404
ICONIC-PsA 1: daily icotrokinra vs placebo in 552 adults with active psoriatic arthritis who haven’t had biologic drugs: joint improvement (ACR 20) at week 16
Active, not recruiting; main data collected May 2026, no results reported
Phase 3NCT06807424
ICONIC-PsA 2: daily icotrokinra vs placebo in about 750 adults with active psoriatic arthritis, including people already treated with biologics: ACR 20 at week 16
Recruiting; primary completion expected February 2027
Phase 3NCT07196748
ICONIC-UC: induction and maintenance vs placebo in about 882 adults with moderate-to-severe ulcerative colitis (plus an open-label teen study): remission at weeks 12 and 40
Recruiting; primary completion expected January 2028
Phase 2b/3NCT07196722
ICONIC-CD: icotrokinra vs placebo in about 1,092 adults with moderate-to-severe Crohn’s disease: clinical response and remission at week 12
Recruiting; primary completion expected September 2028
Phase 3NCT06934226
ICONIC-ASCEND: icotrokinra vs placebo and ustekinumab, an injected IL-12/23 antibody, in 752 people with moderate-to-severe plaque psoriasis
Active, not recruiting; main data collected November 2025, no journal paper yet
Approval rests on four phase 3 trials in about 2,500 people with plaque psoriasis, placebo-controlled for 16 weeks and followed for about a year (2 years in one trial), plus a 255-person phase 2 trial. Long-term risks of blocking IL-23, such as rare infections or cancers, need longer follow-up. The ulcerative colitis evidence is one 12-week phase 2b trial reported only as an abstract, and psoriatic arthritis results haven’t been reported.
How it’s supplied
Film-coated tablets, swallowed whole or dispersed in water, once a day on an empty stomach, in 200 mg strengths. Taken by mouth, so there’s nothing to mix or draw up, and the calculator and dose log don’t apply.
Datasheet
Half-life
about 12 hoursLabelMedian, after a 200 mg oral dose; steady state in about 3 days. Under 1% of a dose is absorbed (animal data), and 37–81% leaves unchanged in stool.
Type
Peptide, 13 amino acids
Molecular weight
1,898.2 g/mol
Formula
C90H120N20O22S2
Sequence
Ac-[Pen]-NT-[7-Me-Trp]-[Lys(Ac)]-[Pen]-[Tyr(O-2-aminoethyl)]-[2-Nal]-[Ahp]-EN-[3-Pal]-[Sar]-NH2Ring closed by a disulfide between the two penicillamines; Ahp = 4-aminotetrahydropyran-4-carboxylic acid
Storage before use
Tablets in a bottle with a desiccant. Store at 20–25 °C (15–30 °C allowed) in the original package to protect from moisture; don’t throw away the desiccant.
After mixing or opening
Keep the bottle tightly closed (EU label). A tablet dispersed in water is drunk within 15 minutes (US label).
Half-life: Icotyde prescribing information, section 12.3 (DailyMed, March 2026); EU summary of product characteristics, section 5.2
Molecule: Icotyde label section 11 (13 amino acids, formula, 1,898.17); Fourie et al. 2024 (structure); PubChem CID 162462321; FDA GSRS (UNII MUW8FP7HNZ). Tablets contain the hydrochloride (about 1,934.6).
Storage:Label Icotyde prescribing information, sections 2.3 and 16 (DailyMed, March 2026); EU summary of product characteristics, section 6.4
Icotyde tablets contain the hydrochloride salt: each holds 200 mg of icotrokinra (201.6–202.8 mg of the salt). Under 1% is absorbed, and a high-fat meal cut absorption by 43%, so tablets are taken before food.
Cautions
Can raise infection risk, like other drugs that act on the immune system: serious infections were 0.2% vs 0.4% on placebo through week 16. It isn’t started during an active infection and is stopped during a serious one.
Tuberculosis: the US label suggests considering TB testing before starting and avoiding use with active TB; the EU label rules out clinically important active infections.
Live vaccines are avoided during treatment (and for 3 days after, per the EU label); vaccinations are brought up to date first.
Fungal infections such as athlete’s foot and thrush were more common (1.1% vs 0%). One fatal stomach bleed occurred in a person with risk factors, not clearly linked to the drug.
Works only on an empty stomach: under 1% of a dose is absorbed, and food cuts that further.
Questions
What is icotrokinra?
A small ring-shaped peptide, taken as a daily pill, that blocks the receptor for IL-23, an immune signal that drives psoriasis. Injected antibody drugs act on the same pathway.
How does icotrokinra work?
Icotrokinra binds the receptor for IL-23, an immune signaling protein, very tightly and stops IL-23 from attaching. IL-23 keeps a type of inflammatory T cell (Th17) active; blocking it lowered IL-17A, IL-17F, IL-22 and other signals that drive thick, scaly psoriasis plaques. Injected antibody drugs block the same pathway. Its ring shape and unusual building blocks help it survive digestion, yet under 1% of a dose is absorbed. The label says how these signal changes lead to clearer skin isn’t fully understood. Safety beyond about 2 years, including rare infections and cancer, is unknown.
Is icotrokinra FDA-approved?
Approved in the US as Icotyde tablets (March 17, 2026) for moderate-to-severe plaque psoriasis in adults, and in children 12 and older weighing at least 40 kg, who are candidates for systemic therapy or phototherapy.
What is the usual icotrokinra dose?
From the label (Icotyde): Adults: 200 mg by mouth once a day on waking, on an empty stomach with water, at least 30 minutes before food. The EU label suggests stopping if there’s no benefit after 24 weeks. From human studies (FRONTIER 1, Bissonnette 2024): Phase 2 doses ran from 25 mg once daily to 100 mg twice daily; responses rose with dose (PASI 75 in 37–79% vs 9% on placebo at week 16). These are the amounts sources reference, not recommendations.
How is icotrokinra taken?
By mouth: film-coated tablets, swallowed whole or dispersed in water, once a day on an empty stomach. On waking, on an empty stomach with water; no food for at least 30 minutes (a high-fat meal cut absorption by 43%). There’s nothing to mix or measure with a syringe.
Who should avoid icotrokinra?
Active serious infection: The EU label rules it out with clinically important active infections; the US label says not to start until an infection is treated and to stop during a serious one. Active or latent tuberculosis: The US label advises considering TB testing first, treating latent TB when past treatment can’t be confirmed, and avoiding use with active TB. Allergy to icotrokinra: Ruled out by the EU label (allergy to the drug or its ingredients); the US label lists no contraindications. The “Who should avoid it” section lists 4 more groups and 3 interactions.
What is the half-life of icotrokinra?
About 12 hours, according to the prescribing information. Median, after a 200 mg oral dose; steady state in about 3 days. Under 1% of a dose is absorbed (animal data), and 37–81% leaves unchanged in stool.
How should icotrokinra be stored?
Before mixing: Tablets in a bottle with a desiccant. Store at 20–25 °C (15–30 °C allowed) in the original package to protect from moisture; don’t throw away the desiccant. After mixing: Keep the bottle tightly closed (EU label). A tablet dispersed in water is drunk within 15 minutes (US label).
Is icotrokinra banned in sport?
No. Not named on the 2026 list, and S0 doesn’t apply to an approved drug. IL-23 blockers aren’t hormones, growth factors or metabolic modulators, so no prohibited class covers them.
Has icotrokinra been studied in people?
Yes. The human studies section lists 5 published studies. The largest, from 2026, included 2,400 people. Through week 16, rates of adverse events, serious events and infections were similar to placebo; rates stayed steady through week 52 (serious events 4.6 per 100 person-years).
How long has icotrokinra been studied in people?
Trial Pooled phase 3 data cover 2,400 people for up to a year (1,840 person-years). The maker reports ICONIC-TOTAL results through week 112, about 2 years.
Does icotrokinra come in other forms, like a pill or nasal spray?
Label The only form is a daily tablet. Under 1% of a dose is absorbed and food cuts that further, so it’s taken on an empty stomach. Antibody drugs block the same pathway by injection.
Can you drink alcohol while taking icotrokinra?
Precaution The labels don’t mention alcohol, and no study has tested the combination. Icotrokinra isn’t processed by liver enzymes, so a drug interaction with alcohol is unlikely.
Can icotrokinra be taken with semaglutide or tirzepatide?
Precaution No study has combined them, and neither label lists an interaction. Icotrokinra is taken on an empty stomach; whether a GLP-1 drug’s slower stomach emptying changes its absorption is untested.
What happens if you take too much icotrokinra?
Label The US label has no overdose section. Per the EU label, single doses up to 1,000 mg caused no side effects in healthy volunteers. Call Poison Help (1-800-222-1222), or emergency services for severe symptoms.
Sources
Icotyde prescribing information (Janssen, DailyMed, March 2026)
Icotyde EU summary of product characteristics (EMA, September 2026)
Drugs@FDA: Icotyde, NDA 220149, approved March 17, 2026 (priority review)
EMA medicines data: Icotyde (CHMP opinion July 23, 2026; authorized September 18, 2026)
PMDA list of new drug approvals, September 2026: Icotyde tablets 200 mg (approved September 16, 2026)