nirogacestat
Ogsiveo · ATC code L01XX81
Also known as: Nirogasestat
- Key facts
- Active substance
- nirogacestat
- ATC code
- L01XX81
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Ogsiveo 50 mg film‑coated tablets / Ogsiveo 100 mg film‑coated tablets / Ogsiveo 150 mg film‑coated tablets
- Marketing authorisation holder
- Merck Europe B.V.
- Information as of
- 2026-10-29
Key facts
Nirogacestat (Ogsiveo) is an oral gamma secretase inhibitor used to treat progressing desmoid tumours in adults.
What it is used for
- Monotherapy of progressing desmoid tumours in adults who require systemic treatment.
Dosing
- 150 mg twice daily (morning and evening); this dose should not be exceeded. Continue until progression or unacceptable toxicity.
- For certain severe adverse reactions (e.g. persistent Grade 3 diarrhoea, Grade 3 skin reactions, hypophosphataemia, hypokalaemia, ALT/AST ≥ 3 to 5 x ULN), withhold until resolved, then restart at 100 mg twice daily; permanently discontinue for ALT or AST > 5 x ULN.
- A missed dose should not be made up.
- With or without food; tablets should not be broken, chewed or crushed; avoid grapefruit and grapefruit juice.
- Mild to moderate renal or hepatic impairment: no adjustment; not recommended in severe impairment.
Contraindications
- Hypersensitivity to the active substance or any excipient.
- Pregnancy.
- Women of childbearing potential not using highly effective contraception.
- Breast-feeding.
Important warnings
- Diarrhoea: manage with anti-diarrhoeals; withhold and reduce the dose for persistent Grade 3.
- Dermatologic reactions (maculopapular rash, folliculitis, hidradenitis).
- Ovarian toxicity with abnormal reproductive hormones or peri-menopausal symptoms in 75% of women of childbearing potential.
- Non-melanoma skin cancers (basal cell and squamous cell carcinoma): skin examinations before and routinely during treatment.
- May cause foetal harm: negative pregnancy test before starting; highly effective contraception for women and men until 1 week after the last dose.
Side effects
- Most common: diarrhoea (85%), rash (65%), ovarian toxicity in women of childbearing potential (60%), nausea (59%), fatigue (50%), hypophosphataemia (50%), headache (40%) and stomatitis (40%).
- Most frequent serious adverse reaction: ovarian toxicity (premature menopause, 3%); most common severe reactions: diarrhoea (16%) and hypophosphataemia (13%).
Interactions
- Itraconazole increased AUC 8.2-fold; strong and moderate CYP3A4 inhibitors (e.g. clarithromycin, ketoconazole, erythromycin, fluconazole) should be avoided.
- CYP3A4 inducers may lower levels.
- Proton pump inhibitors and H2 blockers are not recommended, as they may reduce bioavailability.
Pregnancy and breastfeeding
- Contraindicated in pregnancy; stop immediately if pregnancy occurs.
- Contraindicated during breast-feeding.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- OgsiveoMerck Europe B.V. · EMEA/H/C/006071
Source: European Medicines Agency (EMA), product information
Brand names in 3 more European countries
- Iceland
- Ogsiveo
- Liechtenstein
- Ogsiveo
- Norway
- Ogsiveo
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Ogsiveo – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/ogsiveo-epar-product-information_en.pdf
Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.