FDA Events for GH Research (GHRS)
This section highlights FDA-related milestones and regulatory updates for drugs developed by GH Research (GHRS).
Over the past two years, GH Research has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
GH001. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
GH001 - FDA Regulatory Timeline and Events
GH001 is a drug developed by GH Research for the following indication: Resistant Depression.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- GH001
- Announced Date:
- May 15, 2025
- Indication:
- Resistant Depression
Announcement
GH Research PLC announced the acceptance of a Pharmaceutical Pipeline Presentation at the American Society of Clinical Psychopharmacology Annual Meeting (ASCP) in Arizona, United States from May 27 – 30, where Professor Michael E. Thase, MD, Professor of Psychiatry, Perelman School of Medicine, University of Pennsylvania will present clinical data from a randomized, double-blind, placebo-controlled Phase 2b clinical trial with GH001 in patients with treatment-resistant depression (TRD) (GH001-TRD-201).
AI Summary
GH Research PLC has announced that its Pharmaceutical Pipeline Presentation has been accepted for the American Society of Clinical Psychopharmacology Annual Meeting in Arizona from May 27 to 30. At the event, Professor Michael E. Thase, MD, from the University of Pennsylvania’s Perelman School of Medicine, will present clinical data from a Phase 2b trial. This randomized, double-blind, placebo-controlled study focused on GH001 in patients with treatment-resistant depression (TRD), providing robust and encouraging evidence about the treatment’s safety and efficacy. The trial results suggest that, if replicated in larger studies, GH001 could mark a significant step forward in treating TRD. The data not only highlights the potential of GH001 as a transformative treatment option but also builds on earlier research efforts, offering new hope for patients who have not found relief with traditional therapies.
Read Announcement- Drug:
- GH001
- Announced Date:
- February 27, 2025
- Indication:
- Resistant Depression
Announcement
GH Research PLC provided updates on its business.
AI Summary
GH Research PLC provided key updates on its business progress. The company is testing its inhalable mebufotenin product candidate, GH001, in a Phase 2b trial for treatment-resistant depression. The trial has shown promising results, with a significant reduction in depression scores and a high remission rate by Day 8. The open-label extension study, which continues to monitor safety and effectiveness over time, is on track for completion in the first quarter of 2025.
Additionally, GH Research is conducting a Phase 1 trial in the United Kingdom that evaluates the performance of a proprietary aerosol delivery device, which will support global clinical programs for GH001. The company also reported strong financial health with cash and marketable securities totaling $182.6 million as of December 31, 2024, along with additional net proceeds from a public offering in February 2025.
Read Announcement- Drug:
- GH001
- Announced Date:
- February 3, 2025
- Indication:
- Resistant Depression
Announcement
GH Research PLC reported the primary endpoint was met in a randomized, double-blind, placebo-controlled Phase 2b clinical trial with GH001, an inhalable mebufotenin product candidate, in patients with treatment-resistant depression (TRD) (GH001-TRD-201).
AI Summary
GH Research PLC announced that its randomized, double-blind, placebo-controlled Phase 2b clinical trial of GH001, an inhalable mebufotenin treatment for patients with treatment-resistant depression (TRD), met its primary endpoint. In the trial with 81 patients, those treated with GH001 experienced an ultra-rapid antidepressant effect. There was a significant placebo-adjusted reduction of 15.5 points in the Montgomery-Åsberg Depression Rating Scale (MADRS) by Day 8. In addition, a remission rate of 57.5% was achieved in the GH001 group compared to 0% in the placebo group. All secondary endpoints showed statistically and clinically significant improvements, and GH001 was well tolerated with no serious adverse events reported. This early success suggests that GH001 could offer a new, swift treatment option for patients struggling with severe depression.
Read Announcement- Drug:
- GH001
- Announced Date:
- January 31, 2025
- Indication:
- Resistant Depression
Announcement
GH Research PLC announced that it will host a conference call and live webcast on Monday, February 3, 2025, at 8.00 a.m. EST to provide an update on data from the randomized, double-blind, placebo-controlled Phase 2b trial of GH001 in treatment-resistant depression (TRD).
AI Summary
GH Research PLC announced that it will host a conference call and live webcast on Monday, February 3, 2025, at 8:00 a.m. EST. During the call, the company will provide an update on its ongoing randomized, double-blind, placebo-controlled Phase 2b trial of GH001 in treatment-resistant depression (TRD). The session will review new data about GH001, a novel mebufotenin therapy delivered through a proprietary inhalation method, which has shown promising results in previous trials. Investors and interested parties are encouraged to register in advance to join the live webcast available under the "Events & Presentations" section of the company’s website.
This update is a key event for GH Research PLC as it continues to advance its strategic focus on innovative treatments for psychiatric and neurological disorders, particularly targeting patients suffering from TRD.
Read Announcement- Drug:
- GH001
- Announced Date:
- January 10, 2025
- Estimated Event Date Range:
- January 1, 2025 - March 31, 2025
- Target Action Date:
- Q1 2025
- Indication:
- Resistant Depression
Announcement
GH Research PLC announced that Top-line data from our randomized, double-blind, placebo-controlled Phase 2b trial in TRD on track to be announced in Q1 2025
AI Summary
GH Research PLC announced that top-line data from their randomized, double-blind, placebo-controlled Phase 2b trial in treatment-resistant depression (TRD) is on track to be released in the first quarter of 2025. The trial enrolled 80 TRD patients and included a six-month open-label extension, with the final patient visit scheduled for early 2025. This milestone highlights the company’s commitment to transforming treatment options for patients with psychiatric disorders using their novel mebufotenin-based therapy, GH001. With the Phase 2b trial completed and data eagerly awaited, the company’s progress reinforces its focus on rigorous clinical research and development. This update is an important step forward for GH Research PLC as it continues to work through the necessary steps for regulatory approvals and prepares for further engagement with the FDA.
Read Announcement- Drug:
- GH001
- Announced Date:
- January 10, 2025
- Estimated Event Date Range:
- January 1, 2025 - June 30, 2025
- Target Action Date:
- H1 2025
- Indication:
- Resistant Depression
Announcement
GH Research PLC announced that Full response to the IND hold planned to be submitted in mid-2025
AI Summary
GH Research PLC announced that it plans to submit a full response to the IND hold in mid-2025. The company received this hold from the FDA, which requested additional information before GH001 can move forward in clinical trials. GH Research has completed an inhalation toxicology study in a non-rodent species (dogs), showing no adverse findings in the respiratory tracts, as well as another study in rats that confirmed previously observed effects are specific to this species. The company is now finalizing additional device design verification details required by the FDA. These steps, along with the completed studies, are expected to address the agency’s concerns and allow the IND hold to be lifted. GH Research is focused on resolving these regulatory issues so that its ongoing clinical programs for GH001 can proceed as planned.
Read Announcement- Drug:
- GH001
- Announced Date:
- January 10, 2025
- Indication:
- Resistant Depression
Announcement
GH Research PLC oday provided updates on its business and highlighted key upcoming milestones.
AI Summary
GH Research PLC provided a business update highlighting several key upcoming milestones. The company shared promising clinical progress with its lead candidate, GH001, which has shown rapid and robust antidepressant effects in its recent Phase 2a trials for both postpartum depression and bipolar II disorder.
Looking ahead, GH Research is preparing a full response to recent regulatory feedback, with its complete submission planned for mid‑2025. Additionally, the company expects the top‑line data from its Phase 2b trial in treatment-resistant depression to be announced in the first quarter of 2025, with the open‑label extension of the trial on track for early completion. These steps underline the company’s commitment to advancing its pipeline and meeting important clinical and regulatory milestones.
Read Announcement- Drug:
- GH001
- Announced Date:
- September 3, 2024
- Indication:
- Resistant Depression
Announcement
GH Research PLC provided updates on its business.
AI Summary
GH Research PLC provided key updates on its business activities in its Q2 2024 report. The company highlighted significant progress in its clinical development efforts for treatments targeting psychiatric and neurological disorders and announced the promotion of Dr. Velichka “Villy” Valcheva to Chief Executive Officer. This leadership change is set to steer the company into its next phase of growth.
The Phase 2b trial for GH001, designed to treat patients with treatment-resistant depression, is progressing as planned, with the double-blind phase expected to conclude in Q3 2024 and the six-month open-label extension completing in Q1 2025. In addition, a Phase 1 trial to assess a proprietary aerosol delivery device in healthy subjects has received regulatory approval in the UK and is actively recruiting. The company’s robust cash position supports these ongoing initiatives and future research efforts.
Read Announcement- Drug:
- GH001
- Announced Date:
- September 3, 2024
- Estimated Event Date Range:
- January 1, 2025 - March 31, 2025
- Target Action Date:
- Q1 2025
- Indication:
- Resistant Depression
Announcement
GH Research PLC announced that expected completion of 6-month open-label extension phase in Q1 2025
AI Summary
GH Research PLC announced positive progress in its Phase 2b clinical trial for GH001 in patients with treatment-resistant depression. The study, conducted at about 20 sites across seven European countries, is recruiting patients and is on schedule. The double-blind phase of the trial is expected to be completed in the third quarter of 2024. Following this, the 6-month open-label extension phase is slated for completion in the first quarter of 2025. In this trial, GH001, an inhaled mebufotenin product candidate, is given on a single initial dosing day using a commercial inhalation device, without extra required psychotherapy visits around the dosing day. This update highlights a key milestone for GH Research’s efforts to develop innovative treatments for treatment-resistant depression while reinforcing its commitment to advancing clinical-stage psychiatric therapies.
Read Announcement- Drug:
- GH001
- Announced Date:
- September 3, 2024
- Estimated Event Date Range:
- July 1, 2024 - September 30, 2024
- Target Action Date:
- Q3 2024
- Indication:
- Resistant Depression
Announcement
GH Research PLC announced that Phase 2b clinical trial of GH001 in patients with treatment-resistant depression on track for expected completion of double-blind phase in Q3 2024
AI Summary
GH Research PLC announced an update on its clinical development efforts for GH001, an inhaled mebufotenin product candidate for treatment-resistant depression. The company is conducting a multi-center, randomized, double-blind, placebo-controlled Phase 2b clinical trial in approximately 80 patients with treatment-resistant depression across around 20 sites in seven European countries. Recruitment is proceeding as planned, with the double-blind phase expected to be completed by the third quarter of 2024. Following that, a 6‑month open‑label extension phase is anticipated to finish in the first quarter of 2025. Top-line data for the double‑blind phase may be available in late 2024 or early 2025. This trial marks a key step in the company’s goal to offer a new, rapid-acting treatment option for patients who have not benefited from existing therapies.
Read Announcement
GH Research FDA Events - Frequently Asked Questions
As of now, GH Research (GHRS) has not received any FDA approvals for its therapy in the last two years.
In the past two years, GH Research (GHRS) has reported FDA regulatory activity for GH001.
The most recent FDA-related event for GH Research occurred on May 15, 2025, involving GH001. The update was categorized as "Presentation Update," with the company reporting: "GH Research PLC announced the acceptance of a Pharmaceutical Pipeline Presentation at the American Society of Clinical Psychopharmacology Annual Meeting (ASCP) in Arizona, United States from May 27 – 30, where Professor Michael E. Thase, MD, Professor of Psychiatry, Perelman School of Medicine, University of Pennsylvania will present clinical data from a randomized, double-blind, placebo-controlled Phase 2b clinical trial with GH001 in patients with treatment-resistant depression (TRD) (GH001-TRD-201)."
Currently, GH Research has one therapy (GH001) targeting the following condition: Resistant Depression.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:GHRS) was last updated on 7/12/2025 by MarketBeat.com Staff
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