Schizophrenia
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Sign up freeTop drugs studied for this disease
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EMA withdrawal · 2023-07-07EMA Application withdrawn: Asimtufii (aripiprazole monohydrate) — Otsuka Pharmaceutical Netherlands B.V.
The EMA has withdrawn the application for Asimtufii (aripiprazole monohydrate) by Otsuka Pharmaceutical Netherlands B.V. for schizophrenia.
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FDA approval · 2023-06-29FDA Approved: ARIPIPRAZOLE — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal Pharmaceuticals LLC's supplemental application for ARIPIPRAZOLE, granting approval of the generic ARIPIPRAZOLE product.
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CLINICAL_TRIALS research · 2023-06-22Clinical Trial Update: Novel Pharmacotherapy Approaches in Smokers With Serious Mental Illness [Phase 4]
Phase 4 trial update on novel pharmacotherapy approaches for nicotine dependence in smokers with serious mental illness, completed with post…
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CLINICAL_TRIALS trial_result · 2023-06-18Clinical Trial Update: Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia [Phase 3]
Phase 3 trial assessing dexmedetomidine for agitation in schizophrenia completed with results posted.
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CLINICAL_TRIALS trial_result · 2023-06-18Clinical Trial Update: Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia [Phase 3]
Phase 3 clinical trial evaluating dexmedetomidine for agitation in schizophrenia completed with posted results.
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FDA approval · 2023-06-15FDA Approved: ARIPIPRAZOLE — Supplemental Application (Quallent Pharmaceuticals Health LLC)
The FDA approved a supplemental application for aripiprazole from Quallent Pharmaceuticals Health LLC.
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CLINICAL_TRIALS trial_result · 2023-06-15Clinical Trial Update: Trial to Investigate the Safety and Efficacy of GWP42003-P Versus Placebo as Adjunctive Therapy in Participants With Schizophrenia Experiencing Inadequate Response to Ongoing Antipsychotic Treatment [Phase 2]
Phase 2 trial investigating GWP42003-P as adjunctive therapy in schizophrenia with inadequate response to antipsychotics; study terminated w…
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CLINICAL_TRIALS trial_result · 2023-06-15Clinical Trial Update: Prebiotic Treatment in People With Schizophrenia - Pilot Study [Phase 4]
Phase 4 pilot trial evaluating prebiotic treatment in people with schizophrenia and schizoaffective disorder; completed with results posted …
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FDA approval · 2023-06-12FDA Approved: ARIPIPRAZOLE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)
FDA approved a supplemental application for ARIPIPRAZOLE submitted by Unichem Pharmaceuticals (USA), Inc., enabling the generic product to b…
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FDA approval · 2023-06-09FDA Approved: LURASIDONE HYDROCHLORIDE — Original Application (Macleods Pharmaceuticals Limited)
FDA approves a generic Lurasidone hydrochloride tablet (ANDA 212124) from Macleods Pharmaceuticals Limited. The product is indicated for sch…
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FDA approval · 2023-06-07FDA Approved: OLANZAPINE — Supplemental Application (Macleods Pharmaceuticals Limited)
FDA approves a supplemental application for olanzapine from Macleods Pharmaceuticals Limited, granting approval of a generic version of the …
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FDA approval · 2023-06-07FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Macleods Pharmaceuticals Limited)
FDA approved a supplemental application for Quetiapine Fumarate by Macleods Pharmaceuticals Limited under ANDA203359.
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FDA approval · 2023-06-07FDA Approved: ZIPRASIDONE HYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)
FDA approved a supplemental application for ziprasidone hydrochloride filed by Macleods Pharmaceuticals Limited under an ANDA, indicating a …
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FDA approval · 2023-06-07FDA Approved: OLANZAPINE — Supplemental Application (Macleods Pharmaceuticals Limited)
FDA approved a supplemental application for Olanzapine submitted by Macleods Pharmaceuticals Limited (ANDA 203044). This is a regulatory upd…
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FDA approval · 2023-06-07FDA Approved: QUETIAPINE — Supplemental Application (Macleods Pharmaceuticals Limited)
FDA approved a supplemental application for a generic quetiapine product from Macleods Pharmaceuticals Limited.
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FDA approval · 2023-06-05FDA Approved: QUETIAPINE — Supplemental Application (Accord Healthcare Inc.)
The FDA approved Accord Healthcare Inc.'s supplemental application for quetiapine (ANDA 202152), granting approval of a generic quetiapine p…
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CLINICAL_TRIALS trial_result · 2023-05-31Clinical Trial Update: A Study of Paliperidone Palmitate 6-Month Formulation [Phase 3]
Phase 3 study evaluating paliperidone palmitate for schizophrenia has completed and posted results for the 6-month formulation.
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FDA approval · 2023-05-30FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)
FDA approves a supplemental application for quetiapine fumarate submitted by Unichem Pharmaceuticals (USA), Inc.
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CLINICAL_TRIALS trial_result · 2023-05-25Clinical Trial Update: Models of Auditory Hallucination [NA]
A clinical trial studying models of auditory hallucination in individuals with schizophrenia or schizoaffective disorder was terminated, and…
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FDA approval · 2023-05-23FDA Approved: HALOPERIDOL DECANOATE — Original Application (NorthStar RxLLC)
The FDA approved NorthStar RxLLC's HALOPERIDOL DECANOATE as an original ANDA for a long-acting injectable antipsychotic indicated for schizo…
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FDA approval · 2023-05-19FDA Approved: CLOZARIL — Supplemental Application (HLS Therapeutics (USA), Inc.)
FDA approved a supplemental application for Clozaril (clozapine) submitted by HLS Therapeutics (USA), Inc.
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CLINICAL_TRIALS trial_result · 2023-05-15Clinical Trial Update: Treatment of Cognitive and Negative Symptoms in Schizophrenia With N-acetylcysteine [Phase 4]
Phase 4 trial update evaluating N-acetylcysteine for cognitive and negative symptoms in schizophrenia has completed recruitment.
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FDA approval · 2023-05-11FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (BluePoint Laboratories)
FDA approved a supplemental application for quetiapine fumarate submitted by BluePoint Laboratories. This action approves a modification to …
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FDA approval · 2023-05-11FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for quetiapine fumarate filed by Sun Pharmaceutical Industries.
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FDA approval · 2023-05-11FDA Approved: QUETIAPINE EXTENDED RELEASE — Supplemental Application (ACI Healthcare USA, Inc.)
FDA approves a supplemental application for a generic Quetiapine Extended Release product from ACI Healthcare USA, expanding access to the e…