Drugs / Resomelagon
Resomelagon
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Other | — | psoriatic arthritis | — | “SynAct submitted an application to the French Medicines Agency, ANSM, and the local Ethics Committee to initiate a Clinical Phase I study with AP1189.” synactpharma.com ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT07633288 | May 2026 → Aug 2027 expected | viral respiratory tract infection | SynAct Pharma Aps | Recruiting | No outcome recorded |
| Phase 2 | NCT06917001 | Feb 2026 → Jun 2027 expected | dengue disease | Federal University of Minas Gerais | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06671054 | Oct 2024 → Dec 2025 overdue | rheumatoid arthritis | SynAct Pharma Aps | Recruiting | No outcome recorded |
| Phase 2 | NCT05604885 | Nov 2022 → Aug 2023 | rheumatoid arthritis | SynAct Pharma Aps | Completed | No outcome recorded |
| Phase 2 | NCT05516979 | Sep 2022 → Jul 2023 | rheumatoid arthritis | SynAct Pharma Aps | Completed | Missed primary |
| Phase 2 | NCT04456816 | Aug 2020 → Jun 2026 overdue | idiopathic membranous glomerulonephritis | SynAct Pharma Aps | Recruiting | No outcome recorded |
| Phase 2 | NCT04004429 | Aug 2019 → Nov 2021 | rheumatoid arthritis | SynAct Pharma Aps | Completed | Met primary |
News releases announcing trial results or a regulatory action · 48
| Date | Issuer | Release |
|---|---|---|
| 2026-09-07 | SynAct Pharma Aps | Results Further analysis of the Phase 2b ADVANCE study reinforces Phase 2b EXPAND results and supports Phase 3 development – FDA discussions on trial design planned for Q4 2026 synactpharma.com ↗
SynAct Pharma AB (publ) (“SynAct”) (Nasdaq Stockholm: SYNACT), a clinical-stage biotechnology company focused on treating inflammation through a novel therapeutic approach known as “pro-resolution”, today announced results from a post-hoc analysis of the Phase 2b ADVANCE study evaluating resomelagon in treatment-naïve patients with highly active rheumatoid arthritis (“RA”). |
| 2026-08-28 | SynAct Pharma Aps | Results SynAct Pharma to present new resomelagon preclinical data on Phase 3-ready RA therapeutic candidate at the 17th World Congress of Inflammation 2026 synactpharma.com ↗
The data further reinforce growing evidence on the role of pro-resolution mechanisms in treating inflammatory and infectious diseases, including osteoarthritis (OA) and hard-to-treat bacterial infections. |
| 2026-07-09 | SynAct Pharma Aps | Results Resomelagon shows reduced inflammation and joint damage in osteoarthritis model synactpharma.com ↗
Preliminary findings indicate that resomelagon modulates early inflammatory responses following DMM surgery. |
| 2026-06-15 | SynAct Pharma Aps | Results Phase 2b ADVANCE study demonstrates positive effects of resomelagon in Rheumatoid Arthritis – supports phase 3 design, regulatory interactions, and partnering synactpharma.com ↗
The treatment potential was further supported by a significant reduction of CRP (p=0,0037) which was not present in the placebo treated control group. |
| 2026-06-12 | SynAct Pharma Aps | Regulatory SynAct obtains key US patent for resomelagon securing exclusivity until 2044 synactpharma.com ↗
SynAct Pharma AB (publ) (“SynAct”) announced today that the United States Patent and Trademark Office (USPTO) have provided the issue notification of US patent 12,661,336 with issue date 23 June 2026 and more than 2 years of Patent Term Adjustment added to the patent’s expiry date. |
| 2025-05-12 | SynAct Pharma Aps | Regulatory SynAct receives Issue Notification and Patent Term Adjustment for US patent covering resomelagon (AP1189) combination therapy synactpharma.com ↗
SynAct Pharma AB (publ) (“SynAct”) announced today that the Unites States Patent and Trademark Office (USPTO) has provided the issue notification of US patent 12,303,489 with issue date 20 May 2025 and more than 2 years of Patent Term Adjustment added to the patent’s expiry date. |
| 2024-11-27 | SynAct Pharma Aps | Regulatory SynAct Pharma receives EU trial approval for the Phase 2b ADVANCE study with resomelagon (AP1189) synactpharma.com ↗
SynAct Pharma AB (“SynAct”) (Nasdaq Stockholm: SYNACT), a clinical-stage biotechnology company focused on resolving inflammation through selective activation of the melanocortin system, today announces that the company has received clinical trial approval in the EU for the Phase 2b ADVANCE study in newly diagnosed severe rheumatoid arthritis (RA) patients with the lead compound resomelagon (AP1189). |
| 2024-11-14 | SynAct Pharma Aps | Results SynAct Pharma presents positive clinical data on resomelagon (AP1189) supporting development for the treatment of RA at ACR Convergence synactpharma.com ↗
“The results of the EXPAND-study in early rheumatoid arthritis patients with very active disease are very encouraging,” says co-author of the abstract, rheumatology Professor Philip Conaghan, MD PhD, University of Leeds, UK. |
| 2024-08-30 | SynAct Pharma Aps | Results First scientific publication showing treatment potential of a pro-resolving compound in human virus infection synactpharma.com ↗
Resomelagon significantly reduced disease activity in an animal model of betacoronavirus (MHV-A59 virus) induced pulmonary infection and in an animal model of SARS-CoV-2 virus induced pulmonary infection. |
| 2024-07-01 | SynAct Pharma Aps | Regulatory SynAct initiates filing process for Phase 2b ADVANCE study with resomelagon synactpharma.com ↗
SynAct initiates filing process for Phase 2b ADVANCE study with resomelagon |
| 2024-03-10 | SynAct Pharma Aps | Results SynAct Pharma announces outcomes of the independent audit of the 4-week RESOLVE P2a clinical trial in Rheumatoid Arthritis synactpharma.com ↗
The analyses of the study identified a large degree of heterogeneity in the recruited patient population. |
| 2024-02-22 | SynAct Pharma Aps | Results SynAct Pharma announces additional data from the EXPAND P2b clinical trial supporting continued development of the compound in rheumatoid arthritis synactpharma.com ↗
In this subpopulation of patients, 100mg of daily resomelagon demonstrated a consistent and statistically significant response to therapy over placebo across assessed outcome measures. |
| 2023-10-03 | SynAct Pharma Aps | Results SynAct Pharma announces additional data from the EXPAND P2b clinical trial further supporting efficacy and activity seen in patients with elevated CRP synactpharma.com ↗
SynAct Pharma AB (Nasdaq Stockholm: SYNACT) , a clinical stage biotechnology company focused on the resolution of inflammation through the selective activation of the melanocortin system, today reported additional results from the 12-week Phase 2b EXPAND study of 100mg once-daily oral resomelagon (AP1189) in newly diagnosed rheumatoid arthritis (RA) patients experiencing severe disease activity. |
| 2023-09-12 | SynAct Pharma Aps | Results SynAct Pharma announces additional data from the EXPAND P2b clinical trial and identifies population with responsiveness to resomelagon synactpharma.com ↗
A sub-population of patients with a baseline marker of systemic inflammation (CRP > 3mg/L) demonstrated a consistent response to therapy over placebo across all assessed outcome measures |
| 2023-09-04 | SynAct Pharma Aps | Results SynAct Pharma announces top line data from the 12-week EXPAND P2b clinical trial in severely active newly diagnosed rheumatoid arthritis patients synactpharma.com ↗
The study did not meet its primary endpoint of significance over placebo with the ACR20 outcome. |
| 2022-11-01 | SynAct Pharma Aps | Regulatory SynAct Pharma receives IND clearance from the FDA for Phase 2a/b trial of AP1189 in RA synactpharma.com ↗
SynAct Pharma AB (publ) (“SynAct”), a clinical stage biotech company with a unique portfolio of melanocortin receptor agonists, today announced it has received clearance from the US Food and Drug Administration (FDA) of its Investigational New Drug (IND) application for a Phase 2a/b study in Rheumatoid Arthritis (RA) with the company’s lead compound AP1189. |
| 2022-09-30 | SynAct Pharma Aps | Regulatory SynAct Pharma submits IND for US Phase 2a/b clinical trial synactpharma.com ↗
SynAct Pharma AB (publ) (“SynAct”) today announced that the company has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA), with the aim to commence its Phase 2a/b clinical trial RESOLVE with AP1189 in the United States. |
| 2022-09-14 | SynAct Pharma Aps | Regulatory Approval of amended study protocol for the Phase 2a study in iMN synactpharma.com ↗
Therefore, and as previously communicated, the Company submitted a major amendment to the study protocol in July 2022, which has now been approved by the Danish Medicines Agency and is being assessed in Sweden and Norway. |
| 2022-08-25 | SynAct Pharma Aps | Regulatory CTA approved for the Phase 2b study EXPAND synactpharma.com ↗ |
| 2022-06-29 | SynAct Pharma Aps | Regulatory SynAct Pharma recieves pre-IND response from the US FDA synactpharma.com ↗ |
| 2022-06-21 | SynAct Pharma Aps | Regulatory SynAct Pharma submits CTA for Clinical Phase 2b Study in RA synactpharma.com ↗
SynAct Pharma AB (“SynAct”) today announced that it has submitted a Clinical Trial Application (CTA) to initiate the clinical Phase 2b study, EXPAND, with the Company’s candidate drug, AP1189, in patients with newly diagnosed rheumatoid arthritis (RA). |
| 2022-05-04 | SynAct Pharma Aps | Results SynAct Pharma completes clinical pharmacokinetic test of AP1189 tablet synactpharma.com ↗
The data confirms the tablet formulation as superior to, the until now used, AP1189 suspension. |
| 2021-12-02 | SynAct Pharma Aps | Results SynAct Pharma announces additional data from the BEGIN study synactpharma.com ↗
SynAct Pharma AB (“SynAct”) today announced additional results on the secondary endpoints ACR50 and ACR70 from the Phase 2a study of AP1189 (BEGIN) in early rheumatoid arthritis (RA) patients experiencing severe disease activity. |
| 2021-11-30 | SynAct Pharma Aps | Results SynAct Pharma’s AP1189 meets primary endpoint and demonstrates favorable safety profile in Rheumatoid Arthritis patients with active joint disease in the Phase 2a BEGIN study synactpharma.com ↗
SynAct Pharma AB (“SynAct”) today announced top-line results from the Phase 2a study of AP1189 in early rheumatoid arthritis (RA) patients experiencing severe disease activity. |
| 2021-11-23 | SynAct Pharma Aps | Results SynAct Pharma reports positive PK data on AP1189 tablets synactpharma.com ↗
SynAct Pharma AB (“SynAct”) today announced that it has received positive data from the first part of the ongoing pharmacokinetic (PK) study of AP1189 following oral administration of AP1189 tablets to healthy volunteers. |
| 2021-08-25 | SynAct Pharma Aps | Regulatory SynAct strengthens IP portfolio – Grant of key European patent covering AP1189 synactpharma.com ↗
SynAct Pharma AB (“SynAct”) today announced that a European patent was granted covering the company’s leading drug candidate AP1189 in methods of treating kidney diseases. |
| 2021-07-07 | SynAct Pharma Aps | Results SynAct Pharma AB Announces Additional Data from the Phase 2a Trial of AP1189 in Covid-19 Infected Patients and Reminds of Management Call to Discuss Results synactpharma.com ↗
SynAct Pharma AB (“SynAct”) today announced additional results from all treated patients in the Phase 2a clinical trial of AP1189 in Covid-19 infected patients with pulmonary insufficiency. |
| 2021-06-30 | SynAct Pharma Aps | Results SynAct Pharma AB Announces Positive Data from a Phase 2a Trial of AP1189 in Covid-19 Infected Patients synactpharma.com ↗
SynAct Pharma AB (“SynAct”) today announced topline results from the Phase 2a clinical trial of AP1189 in Covid-19 infected patients with pulmonary insufficiency. |
| 2021-03-18 | SynAct Pharma Aps | Results SynAct has initiated dosing in part 2 of the clinical Phase II study with AP1189 in Covid-19 infected patients UK version synactpharma.com ↗
The compound was found to be safe and well tolerated, and the patients were discharged between day 3 and 9 of treatment as none of them developed a need for more intensive pulmonary support. |
| 2020-11-09 | SynAct Pharma Aps | Results SynAct Pharma Announces Positive Interim Phase 2 Data of AP1189 in Rheumatoid Arthritis synactpharma.com ↗
The Data Safety Monitoring Board (DSMB) finds no safety concerns in the 50 mg and 100 mg dose cohorts Signs of efficacy against rheumatoid arthritis was observed. |
| 2020-10-12 | SynAct Pharma Aps | Results English version of PR published 20201012 at 07.33AM SynAct Pharma completes part 1 of clinical phase II study with AP1189 in Rheumatoid Arthritis synactpharma.com ↗
The median CDAI for these patients was 14.5. |
| 2020-06-02 | SynAct Pharma Aps | Regulatory SynAct Pharma´s clinical trial application for AP1189 in Nephrotic Syndrome approved by the Danish Medical Agency synactpharma.com ↗
SynAct Pharma AB (“SynAct”) today announced that the Danish Medical Agency has approved the company’s clinical trial application (CTA) for a Phase IIa study in idiopathic membranous nephropathy patients with Nephrotic Syndrome. |
| 2020-05-05 | SynAct Pharma Aps | Results SynAct presents initial data from the first part of the Phase II study within RA and gives an update on its progression synactpharma.com ↗
The first of two tested doses (50 mg) identified to be safe and well-tolerated. |
| 2020-04-03 | SynAct Pharma Aps | Regulatory SynAct Pharma applies for patent for AP1189 within COVID-19 synactpharma.com ↗
The company today announces that the patent application has been submitted to the European Patent Office, which covers the use of AP1189 for the treatment of COVID-19 infection, including ARDS and SIRS. |
| 2020-03-31 | SynAct Pharma Aps | Regulatory SynAct Pharma submits clinical trial application for AP1189 in Nephrotic Syndrome synactpharma.com ↗
SynAct Pharma AB (“SynAct”) today announced that the company has submitted a clinical trial application (CTA) to the Danish Medicines Agency to initiate a Phase IIa study with its lead candidate drug AP1189 in Idiopathic Membranous Nephropathy (IMN). |
| 2019-11-11 | SynAct Pharma Aps | Regulatory SynAct receives approval from the Swedish Medical Product Agency and the Swedish Ethical Review Authority regarding the clinical Phase IIa study with AP1189 synactpharma.com ↗
SynAct (“SynAct”) announces that the company has received approval from the Swedish Medical Product Agency and the Swedish Ethical Review Authority to conduct the company’s Phase IIa study with the drug candidate AP1189. |
| 2019-03-29 | SynAct Pharma Aps | Regulatory SynAct applies for start of phase IIa clinical study in patients with active arthritis synactpharma.com ↗ |
| 2019-02-11 | SynAct Pharma Aps | Results SynAct reported positive phase I results for candidate drug AP1189 and prepared funding for broadened phase II programmes synactpharma.com ↗
The study shows that AP1189 is safe and up to 100 mg once daily for 14 days is well tolerated. |
| 2018-12-10 | SynAct Pharma Aps | Results SynAct’s candidate drug AP1189 exhibits continued favourable safety and plasma profiles in the multiple-dose part of the Phase I study synactpharma.com ↗
SynAct Pharma AB (“SynAct”) today announced that the candidate drug AP1189 exhibits a continued favourable safety profile and a very promising plasma profile in the second cohort, where healthy subjects have been dosed for 14 days. |
| 2018-10-22 | SynAct Pharma Aps | Results SynAct Pharma announced that AP1189 exhibits a favourable plasma profile in the Phase I study’s initial multiple-dose part synactpharma.com ↗
SynAct Pharma AB (“SynAct”) today announced that candidate drug AP1189 exhibited a promising plasma profile in the first cohort of healthy subjects after 14 days of repeated dosing. |
| 2018-08-20 | SynAct Pharma Aps | Results SynAct Pharma announced positive data from preclinical study in nephrotic syndrome with candidate drug AP1189 synactpharma.com ↗
The study shows that daily dosing for four weeks with candidate drug AP1189 (currently in clinical phase I) provided a significant reduction in proteinuria (protein loss via the kidneys) in a trial model for nephrotic syndrome. |
| 2018-07-23 | SynAct Pharma Aps | Regulatory SynAct Pharma obtains regulatory approval for the implementation of the multiple-dose part in Phase I study with candidate drug AP1189 synactpharma.com ↗
SynAct Pharma AB (“SynAct”) announced today, 23rd July 2018, that the Belgian Medicines Agency, the Federal Agency for Medicine and Health Product (FAMHP), and the local Ethics Committee have approved the company’s application to complete the multiple-dose part of the ongoing Phase I study with a suspension formulation of candidate drug AP1189. |
| 2018-06-12 | SynAct Pharma Aps | Results SynAct Pharma adapts the continued clinical development programme for AP1189 based on new results from the Phase I study synactpharma.com ↗
SynAct Pharma AB (“SynAct Pharma”) today announced that the company has decided to adapt the clinical development programme for the candidate drug AP1189 based on new results from the first multiple-dose cohort in the ongoing Phase I study. |
| 2017-10-03 | SynAct Pharma Aps | Results The first part of the clinical Phase I study with SynAct Pharma’s drug candidate AP1189 successfully completed synactpharma.com ↗
Preliminary data showed that AP1189 exhibited a good safety profile and is well tolerated at doses that exceed the expected therapeutic effect by a good margin. |
| 2017-05-10 | SynAct Pharma Aps | Regulatory SynAct Pharma AB receives approval to start Clinical Phase I study with AP1189 – a new potential treatment for psoriatic arthritis synactpharma.com ↗
SynAct Pharma AB (“SynAct”) today announced that the company has received all the regulatory approvals necessary to start the first clinical study with the candidate drug AP1189. |
| 2017-04-25 | SynAct Pharma Aps | Regulatory SynAct Pharma AB provides an update on the clinical development plan for AP1189 synactpharma.com ↗
SynAct has submitted applications to the Belgian Medicines Agency and a local Ethics Committee, and the company considers that these will be processed by the authorities by the beginning of June 2017. |
| 2017-02-22 | SynAct Pharma Aps | Regulatory SynAct Pharma AB has received approval from the Ethics Committee and continues its dialogue with the French Medicines Agency synactpharma.com ↗
The Ethics Committee has given its approval to initiate the clinical study. |
| 2016-12-09 | SynAct Pharma Aps | Regulatory SynAct Pharma submits application for start of Phase I clinical study synactpharma.com ↗ |
All press releases naming this drug 95 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Resomelagon | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06917001 ↗ |
| Known as | AP-1189 FREE BASE | ChEMBL registry synonym — accepted as the source's own label CHEMBL5315047 ↗ |
| Known as | AP1189 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04456816 ↗ |
| Known as | RESOMELAGON ACETATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL5315047 ↗ |
| Modality | Small molecule | — CHEMBL5315047 ↗ |
| Route | Oral | “AP1189 tablets for oral use” NCT05516979 ↗ |