DARWIN EU® - Drug utilisation study of intramuscular depot olanzapine

14/04/2026
14/04/2026
EU PAS number:
EUPAS1000000980
Study
Ongoing
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Study identification

EU PAS number

EUPAS1000000980

Study ID

1000000980

Official title and acronym

DARWIN EU® - Drug utilisation study of intramuscular depot olanzapine

DARWIN EU® study

Yes

Study countries

Croatia
Denmark
Germany
Hungary
Sweden

Study description

Since 2024, there has been a critical and prolonged shortage of intramuscular depot olanzapine preparation (brand name: Zypadhera®), with the shortage affecting all marketed strengths in the European Union (210 mg, 300 mg, and 405 mg).
Intramuscular depot olanzapine is indicated for the maintenance treatment of schizophrenia in patients stabilised on oral olanzapine, and its prolonged-release formulation results in sustained exposure that may persist for up to 6–8 months after injection. In the context of the ongoing shortage, patients previously treated with intramuscular depot olanzapine may need to discontinue treatment and switch to another antipsychotic medication.
Treatment switching options could be either alternative long-acting intramuscular antipsychotics or oral antipsychotics.
However, there is a lack of real-world evidence specifically addressing switching patterns following discontinuation of intramuscular depot olanzapine preparation.
Understanding the prescribing trend and switching patterns during this prolonged shortage period is essential to inform clinical decision-making, healthcare planning, and future regulatory guidance.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Amy Lam

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable