Medicines in development

Every medicine for schizophrenia now being tested in people, from first trials to approval.

Last updated 5 November 2026 · Next review February 2027

Most medicines tested in people never reach approval. Names link to their entry in Treatments A–Z.

Under review

1 medicine
MedicineTarget · forLatest resultNextIn Europe
Olanzapine monthly injectionWeltruza, TV-44749 · Teva
Dopamine and serotoninLong-term treatment
Approved in the US in October 2026. In 675 people, symptoms improved about 10 points more than on placebo over 8 weeks; no observation period is needed after each injection.1,2,3
EU decision; no date published
Under review by the EMA since May 2026

Phase 3

9 medicines
MedicineTarget · forLatest resultNextIn Europe
Brexpiprazole once a weekOtsuka
Dopamine and serotoninAcute illness
No results yet.4,5
Results expected September 2027
Recruiting in Romania
BrilaroxazineReviva
Dopamine and serotoninAcute illness
In phase 3, symptoms fell 24 points, against 14 on placebo, in 4 weeks. The FDA asked for a second phase 3 trial in 2025.6,7,8
Second phase 3 trial from 2027, if funded
None
CannabidiolSTEP-ENHANCE · University of Oxford
EndocannabinoidsFirst episode, poor response
Small trials gave mixed results; pooled, no clear effect.9,10,11
Recruiting
Authorised in Austria, Germany, Greece, Italy, the Netherlands and Spain; UK
DireclidineNBI-1117568 · Neurocrine
Acetylcholine (M4)Acute illness; relapse
In phase 2, the lowest dose improved symptoms 7.5 points more than placebo (2024).12,13
Phase 3 results; no date given
Recruiting in Bulgaria, Hungary and Romania
EvenamideNewron
Glutamate releaseTreatment-resistant illness, added on
Over 4 weeks, 2.5 points better than placebo. New enrolment at US sites is on hold over a heart-rhythm question.14,15,16,17
First phase 3 results, early 2027
Enrolment complete; trial authorised in 9 EU countries
LB-102N-methyl amisulpride · LB Pharmaceuticals
Dopamine and serotoninAcute illness
In phase 2, 359 people: symptoms fell 14 points, against 9 on placebo, in 4 weeks.18,19
Phase 3 results, first half of 2027
None
RoluperidoneMinerva
Serotonin, sigma-2Negative symptoms
In 2024, the FDA asked for another positive trial before approval.20,21,22
Results, second half of 2027
Authorised in Bulgaria and Romania
Sodium benzoate, with clozapineNaBen · SyneuRx
Glutamate (D-serine)Clozapine-resistant illness
Small trials in Taiwan were positive; larger company trials stopped without results.23,24,25
Estimated end, 2029
Recruiting in Poland
UlotarontOtsuka
TAAR1Acute illness
Two phase 3 trials found no benefit (2023).26,27
Results of a third phase 3 trial, after October 2026
None

Phase 2

13 medicines
MedicineTarget · forLatest resultNextIn Europe
AlofropodectCPL'36 · Celon Pharma
PDE10AAcute illness
In 189 people, the higher dose eased hallucinations and delusions 6 points more than placebo over 4 weeks.28,29
Phase 3 cleared by the FDA; start not yet confirmed
–
Betovumeline–fesoterodineML-007C-MA · MapLight
Acetylcholine (M1, M4)Acute illness
In 307 people, the twice-daily dose improved symptoms 4.5 points more than placebo in 5 weeks; the once-daily dose did not.30,31
Phase 3 results expected 2028
None
Clemastine with exerciseOligoTreat · LMU Munich
Myelin repairMemory and functioning
Recruiting since April 2024.32
Estimated end, June 2028
Recruiting in Germany
EmraclidineAbbVie
Acetylcholine (M4)Acute illness
Two phase 2 trials found no benefit (2024).33,34
A new trial; completion expected February 2028
None
GXV813Novartis
Not disclosedAcute illness
A trial of 142 people began in March 2026.35,36
Primary completion, July 2027
Recruiting in Bulgaria
KYN-5356Kynexis
Glutamate (kynurenic acid)Memory and attention
Enrolment of about 150 people is complete.37,38
Results by the end of 2026
None
N-acetylcysteine or omega-3PsyCARE · Centre Hospitalier Sainte-Anne
Oxidative stress, inflammationEarly psychosis
Earlier trials of each gave mixed results.39,40
Primary completion, December 2026
Recruiting at 12 hospitals in France
NBI-1117570Neurocrine
Acetylcholine (M1, M4)Acute illness
A trial of about 120 people began in February 2026.41,42
Primary completion, August 2027
Recruiting in Bulgaria, Romania and the UK; authorised in Croatia and Poland
OxytocinOXY-APS · Central Institute of Mental Health, Mannheim
Hormone, as a nasal spraySocial skills
Restarted in September 2026 after a temporary halt.43
Estimated end, March 2028
Recruiting in Germany
PomaglumetadDB103 · Orygen, with Denovo
Glutamate (mGlu2/3)Early psychosis, ages 18 to 25
Phase 3 trials found no benefit in 2012; a small open trial began in Melbourne in 2026.44,45
No date given
None
RituximabRegion Örebro County, Uppsala University Hospital
Immune system (B cells)Psychosis, added on
In a first study, symptoms fell by at least 40% in 7 of 9 people, without a comparison group.46,47,48
Results of a 123-person placebo-controlled trial
Sweden; a second, long-term trial authorised in June 2026
TazbentetolSPG302 · Spinogenix
Growth of new synapsesOverall symptoms
Interim results in 16 of 32 people: symptoms fell 11.9 points, against 5.6 on placebo.49,50
–
None
VafidemstatOryzon
LSD1, an enzyme that controls gene activityNegative symptoms
Trial still enrolling.51,52
Estimated end, August 2027
Recruiting in Bulgaria, Poland, Romania, Slovakia and Spain

Phase 1

4 medicines
MedicineTarget · forLatest resultNextIn Europe
NMRA-898Neumora
Acetylcholine (M4)Schizophrenia
Well tolerated so far; it lasts long enough in the body for once-a-day dosing.53,54
Data, second half of 2026
–
NTX-253Neurosterix
Acetylcholine (M4)Schizophrenia
Phase 1 completed in October 2026.55
Phase 2 planned; no date given
–
ST-905Syremis
Acetylcholine (M1, M4)Schizophrenia
A first study in healthy volunteers ended in December 2025.56,57
Second study, estimated end June 2027
France
Xanomeline–trospium injectionBristol Myers Squibb
Acetylcholine (M1, M4)Long-term treatment
Dose-finding study of about 131 people.58
Primary completion, June 2027
None

Approved

2 medicines
MedicineTarget · forLatest resultNextIn Europe
MilsaperidoneBysanti · Vanda
Dopamine and serotoninAdults
Approved in the US in February 2026, because it gives the same blood levels as iloperidone.59,60,61
–
Iloperidone, which it turns into in the body, was refused in the EU in 2026
Xanomeline–trospiumCobenfy · Bristol Myers Squibb
Acetylcholine (M1, M4)Adults
Approved in the US in September 2024. Added to another antipsychotic, it did no better than placebo (2025).62,63,64,65,66
UK: NICE appraisal, July 2027
Not approved in the EU; trials authorised in Bulgaria, Denmark, Poland, Romania and Spain

Stopped

8 medicines since 2023

Medicines leave the pipeline when trials fall short, or when the developer stops.

MedicineTarget · forReachedWhy it stoppedWhen
ALTO-101Alto Neuroscience
PDE4Memory and attention
Phase 2
Missed its main goals; not developed further alone67
April 2026
IclepertinBoehringer Ingelheim
Glutamate (glycine)Thinking
Phase 3
Thinking did not improve, in 1,835 people68,69
January 2025
Iloperidone, in the EUVanda
Dopamine and serotoninAdults
EU review
Refused: an uncertain benefit against a risk to heart rhythm61
February 2026
LuvadaxistatTakeda, Neurocrine
Glutamate (D-serine)Negative symptoms, thinking
Phase 2
No benefit in two trials70,71
By 2026
MK-8189Merck
PDE10AAcute illness
Phase 2b
No better than placebo; no longer in Merck’s pipeline72,73
By 2026
PimavanserinAcadia
Serotonin (5-HT2A)Negative symptoms
Phase 3
No better than placebo74
March 2024
Valbenazine, added onNeurocrine
Dopamine release (VMAT2)Persistent symptoms
Phase 3
Missed its main goal, in 442 people75,76
July 2025
Weekly risperidoneLYN-005 · Lyndra
DopamineLong-term treatment
Phase 3
The company stopped operating before the safety study77,78
April 2025

Sources

  1. Teva Pharmaceuticals. Teva Announces U.S. Food and Drug Administration (FDA) Approval of WELTRUZA (Olanzapine) For Extended-Release Injectable Suspension, as the First and Only Once-Monthly Subcutaneous Injectable Olanzapine for Adults with Schizophrenia. 9 October 2026.
    ir.tevapharm.com (opens in a new tab)
  2. Teva Pharmaceuticals, Medincell. Teva and Medincell Announce Positive Phase 3 Efficacy Results from SOLARIS Trial Evaluating TEV-'749 (olanzapine) as a Once-Monthly Subcutaneous Long-Acting Injectable in Adults with Schizophrenia. 8 May 2024.
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  3. European Medicines Agency. Applications for new human medicines under evaluation by the CHMP: October 2026. October 2026.
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  4. Otsuka Pharmaceutical. A phase 3 trial of brexpiprazole once-weekly (QW) formulation in patients with acute schizophrenia (EU CT 2022-500583-36-00). 4 September 2026.
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  5. Otsuka Pharmaceutical. Trial of Brexpiprazole Once-weekly (QW) Formulation in Patients With Acute Schizophrenia (NCT05325645). 16 September 2026.
    clinicaltrials.gov (opens in a new tab)
  6. Reviva Pharmaceuticals. Reviva Announces Positive Topline Results from Global Pivotal Phase 3 RECOVER Trial of Brilaroxazine in Schizophrenia. 30 October 2023.
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  7. Reviva Pharmaceuticals. Reviva Announces Regulatory Update Regarding the Development of Brilaroxazine for the Treatment of Schizophrenia. 23 December 2025.
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  8. Reviva Pharmaceuticals. Reviva Reports Second Quarter 2026 Financial Results and Recent Business Highlights. 12 August 2026.
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  9. Marchi M, Rachedi K, Bof A, et al. Cannabidiol for psychotic disorders: A meta-analysis of randomized controlled trials. Journal of Psychopharmacology. 2026:02698811261430501.
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  11. University of Oxford. Augmentation with cannabidiol in first episode psychosis: a double blind randomised controlled trial (STEP-ENHANCE; EU CT 2025-521929-32-01). 2026.
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  12. Neurocrine Biosciences. Neurocrine Biosciences initiates Phase 3 registrational program for NBI-1117568 as potential treatment for adults with schizophrenia. 30 April 2025.
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  13. Neurocrine Biosciences. Evaluation of NBI-1117568 in inpatient adults with schizophrenia (EU CT 2025-521215-39-00). 2026.
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  15. Newron Pharmaceuticals. Newron provides update on FDA clinical hold and Phase 3 ENIGMA-TRS development program. 8 October 2026.
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  16. Newron Pharmaceuticals. Newron completes enrollment in pivotal Phase 3 ENIGMA-TRS 1 study. 22 October 2026.
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  17. Newron Pharmaceuticals. Evenamide in patients with treatment-resistant schizophrenia not responding to antipsychotics (EU CT 2024-519836-18-00). 2026.
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  18. Eramo A, Correll CU, Walling DP, et al. Antipsychotic Efficacy and Safety of LB-102 in the Treatment of Adults With Acute Schizophrenia: A Randomized Clinical Trial. JAMA Psychiatry. 2026;83(7):682–693.
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  19. LB Pharmaceuticals. LB Pharmaceuticals Announces Accelerated Timing of Topline Results from the Phase 3 NOVA-2 Trial of LB-102 in Schizophrenia. 22 July 2026.
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  20. Minerva Neurosciences. Minerva Neurosciences receives complete response letter from FDA for new drug application for roluperidone for the treatment of negative symptoms in patients with schizophrenia. 27 February 2024.
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  21. Minerva Neurosciences. Minerva Neurosciences provides second quarter 2026 financial results and business updates. 7 August 2026.
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  22. Minerva Neurosciences. Trial to evaluate efficacy and safety of roluperidone in adults with negative symptoms of schizophrenia (EU CT 2026-525925-19-00). 2026.
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  23. Lin CH, Lin CH, Chang YC, et al. Sodium Benzoate, a D-Amino Acid Oxidase Inhibitor, Added to Clozapine for the Treatment of Schizophrenia: A Randomized, Double-Blind, Placebo-Controlled Trial. Biological Psychiatry. 2018;84(6):422–432.
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  24. SyneuRx International (Taiwan) Corp. Study to evaluate safety and efficacy of NaBen as add-on treatment for schizophrenia in adults (NCT02261519). 2026.
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  25. SyneuRx International (Taiwan) Corp. NaBen, a D-amino acid oxidase inhibitor, as an add-on therapy with clozapine, for residual symptoms of refractory schizophrenia in adults (EU CT 2024-519237-34-00). 2026.
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  26. Sumitomo Pharma, Otsuka Pharmaceutical. Sumitomo Pharma and Otsuka announce topline results from Phase 3 DIAMOND 1 and DIAMOND 2 clinical studies evaluating ulotaront in schizophrenia. 31 July 2023.
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  27. Otsuka Pharmaceutical Development & Commercialization. A trial of the efficacy and safety of SEP-363856 in acutely psychotic participants with schizophrenia (NCT06894212). 2026.
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  28. Wieczorek M, Waszkiewicz N, Gromniak-Haniecka E, et al. PDE10A Inhibition in Schizophrenia: A Randomised, Placebo-Controlled Phase 2 Study of Alofropodect (CPL'36) in Patients Experiencing Acute Schizophrenia. CNS Drugs. 2026;40(9):1295–1305.
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  29. Celon Pharma. FDA Clears Celon Pharma's Schizophrenia Drug for Phase 3 Trial. 8 October 2025.
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  30. MapLight Therapeutics. MapLight Therapeutics Announces Positive Topline Results from Phase 2 ZEPHYR Trial of ML-007C-MA in Schizophrenia. 27 July 2026.
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  31. MapLight Therapeutics. MapLight Therapeutics Reports Second Quarter 2026 Financial Results and Provides Business Update. 14 August 2026.
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  32. Klinikum der Universität München. Combining Clemastine and Aerobic Exercise to Treat Cognitive Dysfunction in Schizophrenia by Targeting Myelin Plasticity (OligoTreat) (EU CT 2024-514457-30-00). 8 October 2026.
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  33. AbbVie. AbbVie provides update on Phase 2 results for emraclidine in schizophrenia. 11 November 2024.
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  34. AbbVie. A study to assess adverse events, change in disease activity, and how oral emraclidine moves through the body in adult participants with schizophrenia (NCT07145918). 2026.
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  35. Novartis. Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia (STAR-1) (NCT07467993). 29 July 2026.
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  36. Novartis Pharma AG. A Phase 2 Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults with Schizophrenia (STAR-1) (EU CT 2025-524058-32-00). 29 April 2026.
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  37. Kynexis. Kynexis Announces First Patient Dosed in Phase 2 Clinical Trial of KYN-5356 for Cognitive Impairment Associated With Schizophrenia. 30 September 2025.
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  38. Kynexis. Kynexis Extends Series A to €97 Million to Advance Potential First-in-Class Investigational Medicine for Cognitive Disorders. 19 August 2026.
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  39. Zhang Q, Liu Z, Wang T, et al. Efficacy and acceptability of adjunctive n‐acetylcysteine for psychotic disorders: Systematic review and meta‐analysis. Human Psychopharmacology: Clinical and Experimental. 2024;39(2):e2880.
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  40. Centre Hospitalier Sainte-Anne. Efficiency of a composite personalised care on functional outcome in early psychosis (PsyCARE) (NCT05796401). 2026.
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  41. Nxera Pharma. Nxera Pharma's Partner Neurocrine Biosciences Doses First Patient in Phase 2 Trial of NBI-1117570 for Adults with Schizophrenia. 13 April 2026.
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  42. Neurocrine Biosciences. Evaluation of NBI-1117570 in Inpatient Adults With Schizophrenia (EU CT 2025-521868-35-00). 19 October 2026.
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  43. Zentralinstitut für Seelische Gesundheit. Enhancing social skills in schizophrenia spectrum disorders – two-arm, double-blind, randomized clinical trial investigating oxytocin vs. placebo as an add-on to an individualized psychosocial treatment (OXY-APS) (EU CT 2023-509433-40-00). 7 August 2026.
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  44. Eli Lilly and Company. Lilly stops Phase III development of pomaglumetad methionil for the treatment of schizophrenia based on efficacy results. 29 August 2012.
    prnewswire.com (opens in a new tab)
  45. Denovo Biopharma. Denovo Biopharma announces partnership with Orygen on Phase 2 study evaluating DB103 (pomaglumetad methionil) in treating psychosis. 11 February 2026.
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  46. Bejerot S, Sigra Stein S, Welin E, et al. Rituximab as an adjunctive treatment for schizophrenia spectrum disorder or obsessive-compulsive disorder: Two open-label pilot studies on treatment-resistant patients. Journal of Psychiatric Research. 2023;158:319–329.
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  47. Region Örebro County. A randomized controlled trial with rituximab for psychotic disorder in adults (RCT-Rits) (NCT05622201). 2026.
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  48. Region Örebro County. Long-term outcomes and safety of repeated rituximab treatment in psychotic disorders – RITS-LONG (EU CT 2026-525324-26-00). 2026.
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  49. Spinogenix. Spinogenix Reports Early Improvements in Phase 2 Trial of Tazbentetol in Patients with Schizophrenia at the Schizophrenia International Research Society (SIRS) 2026 Annual Congress. 26 March 2026.
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  50. Spinogenix. Study of SPG302 in Adults With Schizophrenia (NCT06442462). 6 February 2026.
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  51. Oryzon Genomics. ORYZON reports financial results and corporate update for half year ended June 30th, 2026. 27 July 2026.
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  52. Oryzon Genomics S.A. A Clinical trial to evaluate the efficacy of vafidemstat in negative symptoms and cognitive impairment associated with schizophrenia (EVOLUTION study) (EU CT 2023-507372-42-00). 3 September 2026.
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  53. Neumora Therapeutics. Neumora Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update. 30 March 2026.
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  54. Neumora Therapeutics. Neumora Therapeutics Reports Second Quarter 2026 Financial Results and Provides Business Update. 14 August 2026.
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  55. Addex Therapeutics. Addex Spin-Out Neurosterix Completes Phase 1 Clinical Studies of NTX-253 for Schizophrenia. 8 October 2026.
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  56. Clexio Biosciences. A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Adaptive Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CLE-905-AG, a M1/M4 Muscarinic Agonist when administered alone or in conjunction with a Peripheral Muscarinic antagonist, in Healthy Participants (EU CT 2025-521914-25-00). 7 August 2025.
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  57. Syremis Therapeutics. A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ST-905-AG1 in Healthy Volunteers (EU CT 2026-525700-10-00). 8 June 2026.
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  58. Bristol-Myers Squibb. A Study to Evaluate the Safety, Tolerability, and PK of an Injectable Form of KarXT (NCT07061288). 2 September 2026.
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  59. Vanda Pharmaceuticals. Vanda Pharmaceuticals Announces FDA Approval of BYSANTI (milsaperidone) for the treatment of Bipolar I Disorder and Schizophrenia - A New Chemical Entity Opening New Horizons in Psychiatric Innovation. 20 February 2026.
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  64. National Institute for Health and Care Excellence. Xanomeline tartrate–trospium chloride for treating schizophrenia [ID6716]. 2026.
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  67. Alto Neuroscience. Alto Neuroscience Reports Topline Data from Phase 2 Proof-of-Concept Study of ALTO-101 and Highlights Pipeline Advancements. 2 April 2026.
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  68. Keefe RSE, Harvey PD, Correll CU, et al. Efficacy and safety of iclepertin for cognitive impairment associated with schizophrenia (CONNEX programme): results from three phase 3 randomised controlled trials. The Lancet Psychiatry. 2025;12(12):906–920.
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  69. Boehringer Ingelheim. Boehringer provides update on iclepertin Phase III program in schizophrenia. 16 January 2025.
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  70. Murthy V, Hanson E, DeMartinis N, et al. INTERACT: a randomized phase 2 study of the DAAO inhibitor luvadaxistat in adults with schizophrenia. Schizophrenia Research. 2024;270:249–257.
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  71. Khin NA, Fan RH, Ge T, et al. A phase 2 randomized controlled trial of luvadaxistat in treatment of adults with cognitive impairment associated with schizophrenia: results from the ERUDITE study. Neuropsychopharmacology. 2026;51(11):2065–2073.
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  72. Mukai Y, Kost J, Snow-Adami L, et al. Phase 2b Trial of the PDE10A Inhibitor MK-8189 in People With an Acute Episode of Schizophrenia. Journal of Clinical Psychopharmacology. 2026;46(3):311–319.
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  73. Merck & Co. Product pipeline. 5 November 2026.
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  74. Acadia Pharmaceuticals. Acadia Pharmaceuticals announces top-line results from Phase 3 ADVANCE-2 trial of pimavanserin in negative symptoms of schizophrenia. 11 March 2024.
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  75. Neurocrine Biosciences. Neurocrine Biosciences Reports Second Quarter 2025 Financial Results. 30 July 2025.
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  76. Neurocrine Biosciences. Journey Study: Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment for Schizophrenia (NCT05110157). 10 February 2026.
    clinicaltrials.gov (opens in a new tab)
  77. Citrome L, Nagaraj N, Traverso G, et al. Long-acting oral weekly risperidone (LYN-005) for schizophrenia in the USA (STARLYNG-1): a multicentre, open-label, non-randomised phase 3 trial. The Lancet Psychiatry. 2025;12(7):504–512.
    DOI (opens in a new tab)PubMed (opens in a new tab)
  78. Lyndra Inc. A Study to Evaluate the Safety and Tolerability of Long-Acting Oral Risperidone (LYN-005) in Participants With Schizophrenia or Schizoaffective Disorder (Starlyng-2) (NCT06878833). 8 April 2025.
    clinicaltrials.gov (opens in a new tab)

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