Direclidine clinical trials
Also written NBI-1117568 and HTL0016878.
How each study uses direclidine is sorted by a rule, right about nine times in ten. Readers can ask us to read every study one by one.Ask us to read each study
Get an email when these change. Save the direclidine studies recruiting or about to start — once a week, free: studies that open, close, add sites or post results.
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Example · made-up studies
Breast cancer · Recruiting: 2 came in, 3 changed
What changed in your saved searches, Oct 31 – Nov 6:
A study of drug A after surgery for early breast cancer
Came in · now Recruiting
Drug B with hormone therapy in advanced breast cancer
Changed
· Sites: 4 added, including Seoul and Busan
· Enrollment: 300 → 450 participants
Exercise during chemotherapy
Now Active, not recruiting
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Approvals
The first approval found in each region, with its record
- United States
- Not in FDA's approval records
- European Union
- Not in EMA's list of EU-wide authorisations
From FDA's Drugs@FDA and Purple Book (through openFDA) and the European Medicines Agency, files of Sept 2026 and 27 Oct 2026. National approvals in Europe and other countries are not included. How this is worked out
Studies by the year they started
8 studies that test it; most in 2025 (5)
| Year | Studies |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2022 | 1 |
| 2025 | 5 |
By phase
A phase 1/2 study counts in both.
What it is tested for
Each study’s main condition, where its own words name it, so a study counts once.
Who runs them
Industry 8 · Other 0
Neurocrine Biosciences (6) · Nxera Pharma UK Limited (2)
Coming up
From the study records. Dates are the sponsors’ own estimates and often move.
Reaching primary completion within a year · 2, 2 in phase 3
Studies that test direclidine, phase 3 first.
- Oct 2027NBI-1117568-SCZ3029: Evaluation of NBI-1117568 in Inpatient Adults With SchizophreniaPhase 3 · Neurocrine Biosciences
- Nov 2027NBI-1117568-SCZ3030: Evaluation of NBI-1117568 in Inpatient Adults With SchizophreniaPhase 3 · Neurocrine Biosciences
Studies
Open first, then newest update. How each study uses direclidine is read from its arms, and is right about nine times in ten. Ask us to read each study. These are the studies that list it as an intervention; a search of ClinicalTrials.gov also finds studies that mention it only in a description, such as earlier treatment.
Testing it · 8
- An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current ManiaRecruitingPhase 2Neurocrine BiosciencesNCT07288320Written as NBI-1117568
- NBI-1117568-SCZ3030: Evaluation of NBI-1117568 in Inpatient Adults With SchizophreniaRecruitingPhase 3Neurocrine BiosciencesNCT07105098Written as NBI-1117568
- Efficacy of NBI-1117568 in Preventing Relapse in Adults With SchizophreniaRecruitingPhase 3Neurocrine BiosciencesNCT07227818Written as NBI-1117568
- NBI-1117568-SCZ3032: Long-Term Evaluation of NBI-1117568 in Adults With SchizophreniaRecruitingPhase 3Neurocrine BiosciencesNCT07114874Written as NBI-1117568
- NBI-1117568-SCZ3029: Evaluation of NBI-1117568 in Inpatient Adults With SchizophreniaRecruitingPhase 3Neurocrine BiosciencesNCT06963034Written as NBI-1117568
- Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With SchizophreniaCompletedPhase 2Neurocrine BiosciencesNCT05545111Written as NBI-1117568
- Measurement of HTL0016878 in Cerebrospinal FluidCompletedPhase 1Nxera Pharma UK LimitedNCT04849286Written as HTL0016878
- A Two Part Study to Assess Safety, PK, PD, and Food Effect of Oral HTL0016878CompletedPhase 1Nxera Pharma UK LimitedNCT03244228Written as HTL0016878
Codes
What other systems call direclidine · ClinicalTrials.gg INT018059
- UNII (FDA) TXB4V44U24DIRECLIDINEConfirmed FDA, Wikidata
- Wikidata Q130343832direclidineConfirmed FDA, Wikidata
- NCI Thesaurus C211808DireclidineOne source FDA
| System | Code | Name there | Checked by |
|---|---|---|---|
| UNII (FDA) | TXB4V44U24 | DIRECLIDINE | Confirmed FDA, Wikidata |
| Wikidata | Q130343832 | direclidine | Confirmed FDA, Wikidata |
| NCI Thesaurus | C211808 | Direclidine | One source FDA |
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.