Acromegaly
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS research · 2024-05-16Clinical Trial Update: Acromegaly: Balance, Falls and Fracture Risk
The clinical trial investigating balance, falls, and fracture risk in acromegaly has completed.
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CLINICAL_TRIALS trial_result · 2024-04-25Clinical Trial Update: A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly [Phase 3]
A Phase 3 trial evaluating the efficacy and safety of Octreotide Subcutaneous Depot for Acromegaly has completed.
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FDA approval · 2023-12-05FDA Approved: OCTREOTIDE ACETATE — Original Application (Teva Pharmaceuticals, Inc.)
FDA approved OCTREOTIDE ACETATE as an original application, enabling a Teva-manufactured generic octreotide acetate.
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FDA approval · 2023-07-27FDA Approved: SOMAVERT — Supplemental Application (Pharmacia & Upjohn Company LLC)
The FDA approved a supplemental application for Somavert (pegvisomant) submitted by Pharmacia & Upjohn Company LLC.
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FDA approval · 2023-06-30FDA Approved: OCTREOTIDE — Supplemental Application (Fresenius Kabi USA, LLC)
The FDA approved a supplemental application for octreotide acetate filed by Fresenius Kabi USA, LLC.
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FDA approval · 2023-06-22FDA Approved: OCTREOTIDE ACETATE — Original Application (Gland Pharma Limited)
FDA approved OCTREOTIDE ACETATE from Gland Pharma Limited via an Original Application (ANDA 216839), establishing a generic version of octre…
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FDA approval · 2023-06-13FDA Approved: OCTREOTIDE ACETATE — Original Application (Gland Pharma Limited)
FDA approved the original application for octreotide acetate, a generic product from Gland Pharma Limited. Octreotide acetate is indicated f…
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CLINICAL_TRIALS trial_result · 2023-03-22Clinical Trial Update: Extension Study of IONIS-GHR-LRx Administered to Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands [Phase 2]
Extension study update for Ionis-GHR-LRx in acromegaly patients on long-acting somatostatin receptor ligands; Phase 2 completed.
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FDA approval · 2023-02-21FDA Approved: OCTREOTIDE ACETATE — Supplemental Application (Mylan Institutional LLC)
FDA approved a supplemental application for octreotide acetate by Mylan Institutional LLC under ANDA 079198, granting a supplemental approva…
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FDA approval · 2023-02-21FDA Approved: OCTREOTIDE ACETATE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)
FDA approved a supplemental application to Heritage Pharmaceuticals (Avet) for octreotide acetate, a generic product, under an ANDA.
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CLINICAL_TRIALS trial_result · 2023-01-04Clinical Trial Update: Acromegaly Combination Treatment Study [NA]
A terminated clinical trial update for an acromegaly combination treatment study; results posted in 2023.
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CLINICAL_TRIALS trial_result · 2022-11-14Clinical Trial Update: Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands [Phase 2]
Phase 2 clinical trial assessing safety, tolerability, and efficacy of IONIS-GHR-LRx in acromegaly patients on long-acting somatostatin rece…
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FDA approval · 2022-11-08FDA Approved: BROMOCRIPTINE MESYLATE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for bromocriptine mesylate from Sandoz Inc, approving a modification to an existing generic product'…
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FDA approval · 2022-04-27FDA Approved: BROMOCRIPTINE MESYLATE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
FDA approved a supplemental application for bromocriptine mesylate submitted by Zydus Pharmaceuticals USA Inc.
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CLINICAL_TRIALS trial_result · 2022-04-22Clinical Trial Update: Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly [Phase 3]
A Phase 3 trial comparing oral octreotide capsules with injectable somatostatin analogs in acromegaly has completed with results posted.
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FDA approval · 2021-12-17FDA Approved: LANREOTIDE ACETATE — Original Application (Cipla USA Inc.)
The FDA approved lanreotide acetate from Cipla USA Inc. as an original application, providing a generic option for the somatostatin analog u…
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CLINICAL_TRIALS trial_result · 2021-11-22Clinical Trial Update: Strict IGF-1 Control in Acromegaly [Phase 3]
Phase 3 clinical trial evaluating strict IGF-1 control in acromegaly has completed.
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CLINICAL_TRIALS trial_result · 2021-09-30Clinical Trial Update: A Pilot Study of Pre- and Post-operative Use of Somatuline Depot. [Phase 4]
A Phase 4 pilot trial evaluating pre- and post-operative use of Somatuline Depot was terminated; results posted in 2021 for acromegaly.
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FDA approval · 2021-08-20FDA Approved: SOMAVERT — Supplemental Application (Pharmacia & Upjohn Company LLC)
The FDA approves a supplemental application for Somavert (pegvisomant) submitted by Pharmacia & Upjohn Company LLC. Somavert is used for tre…
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CLINICAL_TRIALS trial_result · 2021-06-02Clinical Trial Update: An Extension Study to Assess the Long-Term Safety and Efficacy of Pasireotide in Participants With Acromegaly [Phase 2]
An extension study reports long-term safety and efficacy data for pasireotide in acromegaly participants (Phase 2), completed with results p…
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CLINICAL_TRIALS trial_result · 2021-04-28Clinical Trial Update: Programme of Acromegaly Screening in Patients With Associated Somatic Disorders
Completed clinical trial evaluating acromegaly screening in patients with associated somatic disorders; results posted in 2021.
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FDA label_change · 2021-01-19FDA Approved: BROMOCRIPTINE MESYLATE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for bromocriptine mesylate from Zydus Pharmaceuticals USA Inc., resulting in labeling changes fo…
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CLINICAL_TRIALS trial_result · 2020-10-19Clinical Trial Update: Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly [Phase 3]
Phase 3 clinical trial update evaluating efficacy and safety of Octreotide capsules (MYCAPSSA) for acromegaly.
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FDA approval · 2020-08-21FDA Approved: BROMOCRIPTINE MESYLATE — Supplemental Application (Padagis US LLC)
FDA approved a supplemental application for Bromocriptine Mesylate submitted by Padagis US LLC.
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FDA label_change · 2020-07-09FDA Approved: SIGNIFOR LAR — Supplemental Application (Recordati Rare Diseases, Inc.)
FDA approved a supplemental application for SIGNIFOR LAR (pasireotide) submitted by Recordati Rare Diseases, Inc., to modify the product lab…