Drugs / IP2018
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | UK (MHRA) | — | sexual dysfunction in major depressive disorder | 2020-03-31 | “it has filed a Phase 2a Clinical Trial Application (CTA) to the Medicines and Healthcare products Regulatory Agency, MHRA, UK, for its candidate drug IP2018.” initiatorpharma.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT04686916 | Dec 2020 → Jul 2023 | erectile dysfunction | Initiator Pharma | Unknown | Met primary |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2023-09-19 | Initiator Pharma | Results Initiator Pharma meddelar indikationsutvidgning av båda sina kliniska läkemedelskandidater till kvinnor med sexuell dysfunktion initiatorpharma.com ↗
Signifikant effekt har nu även visats för både pudafensin och IP2018 i de djurmodeller som testats för FSD. |
| 2023-09-19 | Initiator Pharma | Results Initiator Pharma announces indication expansion – clinical drug candidates active in models of female sexual dysfunction initiatorpharma.com ↗
Significant efficacy has been shown for both pudafensine and IP2018 in the animal models tested for FSD. |
| 2023-08-09 | Initiator Pharma | Regulatory Initiator Pharma obtains IP2018 patent in Europe for treatment of Erectile Dysfunction and Depression initiatorpharma.com ↗
The granted patent confers protection in Europe until 2040. |
| 2023-08-09 | Initiator Pharma | Regulatory Initiator Pharma erhåller patent i Europa för IP2018 mot erektil dysfunktion och depression initiatorpharma.com ↗ |
| 2023-06-05 | Initiator Pharma | Results Initiator Pharma reports dose-dependent significant efficacy of IP2018 in the placebo-controlled Phase IIa clinical trial of Erectile Dysfunction initiatorpharma.com ↗
I am excited that we have observed a significant effect linked to administration, including a clear dose-response effect, of our product IP2018. |
| 2023-06-05 | Initiator Pharma | Results Initiator Pharma rapporterar positiva dosberoende och signifikanta effektdata i den kliniska fas IIa-studien med IP2018 initiatorpharma.com ↗
Jag är glad över att vi har observerat en tydlig effekt kopplad till administrering, inklusive en tydlig dosresponseffekt, av vår produkt IP2018. |
| 2021-06-02 | Initiator Pharma | Regulatory Initiator Pharma – Phase 2a study with IP2018 update initiatorpharma.com ↗
Initiator Pharma A/S, a clinical-stage Life Science company today announced that it has received approval from the Medicines and Healthcare products Regulatory Agency, MHRA, UK and the Ethics Committee for optimizing the study execution of its Phase 2a study with IP2018. |
| 2021-06-02 | Initiator Pharma | Regulatory Initiator Pharma ger uppdatering om bolagets fas 2a-studie med IP2018 initiatorpharma.com ↗
Initiator Pharma A/S, ett bioteknikbolag i klinisk fas, meddelade idag att bolaget erhållit godkännande av brittiska läkemedelsverket, MHRA, och brittiska etikkommittén, EC, att optimera genomförandet av bolagets fas 2a-studie med IP2018. |
| 2020-06-29 | Initiator Pharma | Regulatory Initiator Pharma obtains approval to start Phase 2a trial for IP2018 initiatorpharma.com ↗
Initiator Pharma A/S, a clinical-stage biotech company today announced that it has obtained approval from the Medicines and Healthcare products Regulatory Agency, MHRA, and the Ethical committee (EC) UK, for a Phase 2a clinical trial with its candidate drug IP2018. |
| 2020-06-29 | Initiator Pharma | Regulatory Initiator Pharma får godkänt att starta klinisk fas 2a-studie med IP2018 initiatorpharma.com ↗
Initiator Pharma A/S, ett bioteknikbolag i klinisk fas, meddelade idag att bolaget erhållit godkännande av brittiska läkemedelsverket, MHRA, och brittiska etikkommittén, EC, att starta en klinisk fas 2a-studie med bolagets läkemedelskandidat IP2018. |
| 2020-03-31 | Initiator Pharma | Regulatory Initiator Pharma lämnar in ansökan för start av klinisk fas 2a-studie med IP2018 och utnyttjar optionsavtal med Saniona initiatorpharma.com ↗
Genom inlämnandet av ansökan utnyttjar Initiator Pharma också sitt optionsavtal med Saniona för IP2018. |
| 2020-03-31 | Initiator Pharma | Regulatory Initiator Pharma files CTA for IP2018 Phase 2a and exercises option agreement with Saniona initiatorpharma.com ↗
Initiator Pharma A/S, a clinical-stage biotech company today announced that it has filed a Phase 2a Clinical Trial Application (CTA) to the Medicines and Healthcare products Regulatory Agency, MHRA, UK, for its candidate drug IP2018. |
All press releases naming this drug 24 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | IP2018 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04686916 ↗ |
| Modality | Small molecule | — CHEMBL4650310 ↗ |
| Route | Oral | “single oral dose levels” NCT04686916 ↗ |