Drugs / Trofinetide
Trofinetide
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed Rett syndrome 3 milestones | |||||
| Filed | EU (EMA) | — | Rett syndrome | 2025-01-14 | “submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for trofinetide for the treatment of Rett syndrome” acadia.com ↗ |
| Filed | Other | — | Rett syndrome | 2024-04-22 | “Health Canada has accepted for review the New Drug Submission (NDS) of trofinetide for the treatment of Rett syndrome” neurenpharma.com ↗ “Health Canada has accepted its New Drug Submission (NDS) for trofinetide for the treatment of Rett syndrome” acadia.com ↗ |
| Filed | US (FDA) | — | Rett syndrome | 2022-07-18 | “New Drug Application (NDA) for trofinetide to treat Rett syndrome accepted by the US Food and Drug Administration (FDA)” neurenpharma.com ↗ “Acadia Pharmaceuticals Submits New Drug Application to the U.S. FDA for Trofinetide for the Treatment of Rett Syndrome” neurenpharma.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Label expansions (2) | US (FDA) | DAYBUE | — | 2024-09-30 – 2026-03-27 | fda.gov ↗ |
| Approved | US (FDA) | DAYBUE | — | 2023-03-10 | fda.gov ↗ |
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT01420042 | Feb → Aug 2012 | traumatic brain injury | Neuren Pharmaceuticals Limited | Completed | No outcome recorded |
| Phase 1 | NCT00961779 | Mar → Aug 2010 | traumatic brain injury | Neuren Pharmaceuticals Limited | Completed | No outcome recorded |
| Phase 26 trials · 2 met primary | ||||||
| Phase 2 | NCT02715115 | Mar 2016 → Jan 2017 | Rett syndrome | Neuren Pharmaceuticals Limited | Completed | Met primary |
| Phase 2 | NCT02100150 | Sep 2014 → Jun 2016 | traumatic encephalopathy | Neuren Pharmaceuticals Limited | Terminated | No outcome recorded |
| Phase 2 | NCT01894958 | Jan 2014 → Sep 2015 | fragile X syndrome | Neuren Pharmaceuticals Limited | Completed | Met primary |
| Phase 2 | NCT01703533 | Mar 2013 → Sep 2014 | Rett syndrome | Neuren Pharmaceuticals Limited | Completed | No outcome recorded |
| Phase 2 | NCT01366820 | Feb 2013 → Jan 2016 | brain injury | Neuren Pharmaceuticals Limited | Completed | No outcome recorded |
| Phase 2 | NCT00805818 | Apr 2010 → Jan 2016 | traumatic brain injury | Neuren Pharmaceuticals Limited | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04988867 | Sep 2021 → May 2023 | Rett syndrome | ACADIA Pharmaceuticals Inc. | Terminated | No outcome recorded |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT04776746 | Nov 2020 → Jun 2023 | Rett syndrome | ACADIA Pharmaceuticals Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT04279314 | Jan 2020 → Aug 2022 | Rett syndrome | ACADIA Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 3 | NCT04181723 | Nov 2019 → Oct 2021 | Rett syndrome | ACADIA Pharmaceuticals Inc. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 57
| Date | Issuer | Release |
|---|---|---|
| 2026-08-24 | Neuren Pharmaceuticals Limited | Regulatory European Commission grants marketing authorisation for DAYBU neurenpharma.com ↗
With this approval, DAYBU is authorized to be marketed in all 27 EU member states, as well as Iceland, Liechtenstein, and Norway. |
| 2026-08-24 | ACADIA Pharmaceuticals Inc. | Regulatory European Commission Approves DAYBU® (trofinetide) as the First and Only Treatment for Neurobehavioral Symptoms of Rett Syndrome in the European Union acadia.com ↗
Today's approval in the European Union is an important milestone that recognizes the significant unmet medical need in this rare disease. |
| 2026-06-28 | Neuren Pharmaceuticals Limited | Regulatory DAYBU recommended for approval in the European Union neurenpharma.com ↗ |
| 2026-06-26 | ACADIA Pharmaceuticals Inc. | Regulatory DAYBU® (trofinetide) Recommended for Approval in the European Union by CHMP acadia.com ↗
The CHMP’s positive opinion for DAYBU® is an important milestone in our mission to bring this innovative therapy to the EU, where there are no therapies specifically approved for the neurobehavioral symptoms of this devastating condition, |
| 2026-03-02 | Neuren Pharmaceuticals Limited | Regulatory Acadia confirms plan to request CHMP re-examination neurenpharma.com ↗ |
| 2026-03-02 | ACADIA Pharmaceuticals Inc. | Regulatory Acadia Pharmaceuticals Announces Plan to Request Re-Examination Following Negative CHMP Opinion for Trofinetide for the Treatment of Rett Syndrome acadia.com ↗
Acadia has reviewed the CHMP grounds for refusal in detail and intends to request a re-examination of the opinion. |
| 2026-02-02 | Neuren Pharmaceuticals Limited | Regulatory Acadia provides update on EU regulatory submission neurenpharma.com ↗
Subject to the outcome of the CHMP vote in February, Acadia intends to request a re-examination of the opinion by the CHMP upon its formal adoption. |
| 2026-02-02 | ACADIA Pharmaceuticals Inc. | Regulatory Acadia Pharmaceuticals Provides Update on Regulatory Submission for Trofinetide for the Treatment of Rett Syndrome in the European Union acadia.com ↗
Company expects to receive a negative opinion following oral explanation feedback and intends to request re‑examination upon review of formal adoption. |
| 2026-01-13 | ACADIA Pharmaceuticals Inc. | Regulatory Acadia Pharmaceuticals Provides Business and Pipeline Updates at 44th Annual J.P. Morgan Healthcare Conference acadia.com ↗
Ministry of Health in Israel recently approved DAYBUE oral solution for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older and weighing at least 9 kg, further expanding global access to this treatment. |
| 2025-12-14 | Neuren Pharmaceuticals Limited | Regulatory FDA approves DAYBUE STIX (trofinetide), powder formulation neurenpharma.com ↗
US FDA approves DAYBUE® STIX (trofinetide) for oral solution, a new powder formulation, for Rett syndrome |
| 2025-12-12 | ACADIA Pharmaceuticals Inc. | Regulatory Acadia Pharmaceuticals Announces FDA Approval of DAYBUE® STIX (trofinetide) for Oral Solution, a New Powder Formulation of Trofinetide for the Treatment of Rett Syndrome acadia.com ↗
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the U.S. Food and Drug Administration (FDA) has approved DAYBUE® STIX (trofinetide) for oral solution, a dye- and preservative-free powder formulation of trofinetide for the treatment of Rett syndrome in adult and pediatric patients two years of age and older. |
| 2025-09-12 | ACADIA Pharmaceuticals Inc. | Results Real World Data from LOTUS Study Evaluating Long-term Efficacy and Tolerability Outcomes of DAYBUE® (trofinetide) in Patients with Rett Syndrome Published in Developmental Medicine and Child Neurology acadia.com ↗
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the journal Developmental Medicine and Child Neurology published interim results from the caregiver-reported observational online, open-label, ongoing LOTUS study evaluating effectiveness and tolerability outcomes in patients with Rett syndrome who are prescribed DAYBUE® (trofinetide) under routine clinical care in the U.S. |
| 2025-03-05 | ACADIA Pharmaceuticals Inc. | Results Clinical Data from Open-Label DAFFODIL™ Study Evaluating Long-term Safety of DAYBUE® (trofinetide) in Patients with Rett Syndrome Published in Med acadia.com ↗ |
| 2025-01-14 | Neuren Pharmaceuticals Limited | Regulatory Trofinetide marketing application submitted in Europe neurenpharma.com ↗
Trofinetide marketing application submitted in Europe |
| 2025-01-14 | ACADIA Pharmaceuticals Inc. | Regulatory Acadia Pharmaceuticals Submits Marketing Authorization Application to the European Medicines Agency for Trofinetide for the Treatment of Rett Syndrome acadia.com ↗
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the company has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for trofinetide for the treatment of Rett syndrome in adults and pediatric patients two years of age and older. |
| 2025-01-14 | ACADIA Pharmaceuticals Inc. | Regulatory Acadia Pharmaceuticals Provides Business and Pipeline Updates at 43rd Annual J.P. Morgan Healthcare Conference acadia.com ↗
Announced today that the marketing authorization application for DAYBUE™ has been submitted to the European Medicines Agency (EMA) with expected approval in the first quarter of 2026. |
| 2024-10-16 | Neuren Pharmaceuticals Limited | Regulatory DAYBUE receives marketing authorization in Canada neurenpharma.com ↗
Neuren Pharmaceuticals (ASX: NEU) today announced that its partner Acadia Pharmaceuticals (NASDAQ: ACAD) received Health Canada approval of DAYBUE™ (trofinetide) for the treatment of Rett syndrome in adult and pediatric patients two years of age and older under the Priority Review process. |
| 2024-10-16 | ACADIA Pharmaceuticals Inc. | Regulatory Acadia Pharmaceuticals Announces Health Canada Approval of DAYBUE™ (trofinetide) for the Treatment of Rett Syndrome acadia.com ↗
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that Health Canada has granted marketing authorization of DAYBUE™ (trofinetide) for the treatment of Rett syndrome in adult and pediatric patients two years of age and older under the Priority Review process. |
| 2024-07-18 | ACADIA Pharmaceuticals Inc. | Results Clinical Data from Open-Label Extension LILAC-1™ and LILAC-2™ Studies Evaluating Long-Term Safety and Efficacy of DAYBUE™ (trofinetide) in Patients with Rett Syndrome Published in Med acadia.com ↗
today announced that the journal Med published results from two open-label extension studies, LILAC-1™ and LILAC-2™, which showed that patients treated with DAYBUE™ who completed these studies experienced improvement in Rett symptoms as measured by the Rett Syndrome Behaviour Questionnaire (RSBQ). |
| 2024-06-18 | ACADIA Pharmaceuticals Inc. | Results Acadia Pharmaceuticals Presents DAYBUE™ (trofinetide) Real-World Evidence and Additional Data in Rett Syndrome at the 2024 International Rett Syndrome Foundation (IRSF) Annual Scientific Meeting acadia.com ↗
Acadia Pharmaceuticals, Inc. (Nasdaq: ACAD) today announced that interim data from the open-label real-world LOTUS™ study will be presented at the 2024 International Rett Syndrome Foundation (IRSF) Annual Scientific Meeting, being held this week in Westminster, Colorado. |
| 2024-04-22 | Neuren Pharmaceuticals Limited | Regulatory Trofinetide accepted for Priority Review by Health Canada neurenpharma.com ↗
Health Canada has granted a Priority Review for the submission. |
| 2024-04-22 | ACADIA Pharmaceuticals Inc. | Regulatory Acadia Pharmaceuticals Announces Trofinetide New Drug Submission for Treatment of Rett Syndrome Has Been Accepted for Filing and Priority Review by Health Canada acadia.com ↗
Health Canada has accepted its New Drug Submission (NDS) for trofinetide for the treatment of Rett syndrome, a rare neurodevelopmental disorder. |
| 2023-06-08 | ACADIA Pharmaceuticals Inc. | Results Nature Medicine Publishes Results from Pivotal Phase 3 LAVENDER™ Study Evaluating DAYBUE™ (trofinetide) Efficacy and Safety in Patients with Rett Syndrome acadia.com ↗
In the study, treatment with DAYBUE (n=93) demonstrated statistically significant improvement compared to placebo (n=94) on both co-primary efficacy endpoints, with the following key findings: |
| 2023-04-20 | ACADIA Pharmaceuticals Inc. | Results Acadia Pharmaceuticals to Present DAYBUE™ (trofinetide) Clinical Data and Rett Syndrome Real World Evidence at the 2023 American Academy of Neurology (AAN) Annual Meeting acadia.com ↗
Treatment with Trofinetide Shows Benefit Compared with Placebo in the Ability to Communicate in Individuals with Rett syndrome. |
| 2023-03-12 | Neuren Pharmaceuticals Limited | Regulatory FDA approves Daybue - the first treatment for Rett syndrome neurenpharma.com ↗
On 10 March 2023, the US Food and Drug Administration (FDA) approved DAYBUE™ (trofinetide) for the treatment of Rett syndrome in adult and pediatric patients two years of age and older. |
| 2023-03-11 | ACADIA Pharmaceuticals Inc. | Regulatory Acadia Pharmaceuticals Announces U.S. FDA Approval of DAYBUE™ (trofinetide) for the Treatment of Rett Syndrome in Adult and Pediatric Patients Two Years of Age and Older acadia.com ↗
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the U.S. Food and Drug Administration (FDA) has approved DAYBUE™ (trofinetide) for the treatment of Rett syndrome in adult and pediatric patients two years of age and older. |
| 2022-11-17 | Neuren Pharmaceuticals Limited | Regulatory Jefferies London Healthcare Conference 2022 presentation neurenpharma.com ↗
NDA for trofinetide to treat Rett syndrome accepted by FDA for Priority Review with PDUFA date set for 12 March 2023 |
| 2022-10-19 | Neuren Pharmaceuticals Limited | Regulatory Neuren receives US$10 million milestone payment neurenpharma.com ↗
The payment was due following the US Food and Drug Administration (FDA) acceptance for review of Acadia’s New Drug Application (NDA) of trofinetide for the treatment of Rett syndrome. |
| 2022-09-14 | Neuren Pharmaceuticals Limited | Regulatory Investor presentation, 14 September 2022 neurenpharma.com ↗
NDA for trofinetide to treat Rett syndrome accepted by FDA for Priority Review with PDUFA date set for 12 March 2023 |
| 2022-09-12 | Neuren Pharmaceuticals Limited | Regulatory Rett Syndrome NDA accepted for Priority Review by FDA neurenpharma.com ↗
the US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) of trofinetide for the treatment of Rett syndrome, that was submitted by Neuren’s US partner Acadia Pharmaceuticals (Nasdaq: ACAD). |
| 2022-09-12 | ACADIA Pharmaceuticals Inc. | Regulatory Acadia Pharmaceuticals Announces Trofinetide New Drug Application for the Treatment of Rett Syndrome has been Accepted for Filing and Review by U.S. FDA acadia.com ↗
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) of trofinetide for the treatment of Rett syndrome. |
| 2022-08-07 | Neuren Pharmaceuticals Limited | Results Investor presentation, 8 August 2022 neurenpharma.com ↗
Robustly positive top-line results in pivotal Phase 3 trial |
| 2022-07-18 | Neuren Pharmaceuticals Limited | Regulatory Acadia submits Rett Syndrome New Drug Application to the FDA neurenpharma.com ↗
Melbourne, Australia: Neuren Pharmaceuticals (ASX: NEU) is pleased to report that its US partner Acadia Pharmaceuticals (Nasdaq: ACAD) has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for trofinetide for the treatment of Rett syndrome in adults and pediatric patients two years of age and older. |
| 2022-07-18 | ACADIA Pharmaceuticals Inc. | Regulatory Acadia Pharmaceuticals Submits New Drug Application to the U.S. FDA for Trofinetide for the Treatment of Rett Syndrome acadia.com ↗
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for trofinetide for the treatment of Rett syndrome in adults and pediatric patients two years of age and older. |
| 2022-02-24 | Neuren Pharmaceuticals Limited | Results Investor presentation 25 Feb 2022 neurenpharma.com ↗
Statistically significant improvement over placebo for both co-primary efficacy endpoints: RSBQ (p=0.0175) and CGI-I (p=0.0030), as well as key secondary endpoint: caregiver scale of ability to communicate (p=0.0064) |
| 2021-12-06 | Neuren Pharmaceuticals Limited | Results Positive topline results from Phase 3 trial in Rett syndrome neurenpharma.com ↗
Trofinetide met co-primary efficacy endpoints demonstrating statistically significant improvement over placebo in the Rett Syndrome Behaviour Questionnaire (RSBQ) (p=0.0175) and the Clinical Global Impression of Improvement (CGI-I) (p=0.0030) |
| 2021-12-06 | ACADIA Pharmaceuticals Inc. | Results Acadia Pharmaceuticals Announces Positive Top-line Results from the Pivotal Phase 3 Lavender Trial of Trofinetide in Rett Syndrome acadia.com ↗
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced positive top-line results from the pivotal, Phase 3 Lavender™ study evaluating the efficacy and safety of trofinetide in 187 girls and young women aged 5-20 years with Rett syndrome. |
| 2020-03-16 | Neuren Pharmaceuticals Limited | Regulatory Neuren to capture substantially greater value after Phase 3 neurenpharma.com ↗
Rare Pediatric Disease designation from FDA recently granted |
| 2020-03-03 | Neuren Pharmaceuticals Limited | Regulatory Commentary on potential benefit to Neuren of RPD designation neurenpharma.com ↗
Neuren Pharmaceuticals (ASX: NEU) and ACADIA Pharmaceuticals (Nasdaq: ACAD) earlier today reported that ACADIA’s program to develop trofinetide for Rett syndrome in the United States has received Rare Pediatric Disease designation from the US Food and Drug Administration (FDA). |
| 2020-03-03 | Neuren Pharmaceuticals Limited | Regulatory Rare Pediatric Disease designation received from FDA neurenpharma.com ↗ |
| 2020-03-03 | ACADIA Pharmaceuticals Inc. | Regulatory ACADIA Pharmaceuticals and Neuren Pharmaceuticals Announce Rare Pediatric Disease Designation for Trofinetide for the Treatment of Rett Syndrome acadia.com ↗ |
| 2019-03-27 | Neuren Pharmaceuticals Limited | Results Neuren's Rett syndrome Phase 2 trial published in Neurology neurenpharma.com ↗ |
| 2019-03-27 | ACADIA Pharmaceuticals Inc. | Results Positive Phase 2 Study Results of Trofinetide in Pediatric Rett Syndrome Published in Neurology, the Medical Journal of the American Academy of Neurology acadia.com ↗
Results of the study also showed trofinetide was well-tolerated at all dose levels (50 mg/kg BID, 100 mg/kg BID, and 200 mg/kg BID). |
| 2017-07-20 | Neuren Pharmaceuticals Limited | Regulatory Neuren granted Type B Meeting with FDA for Rett syndrome neurenpharma.com ↗ |
| 2017-03-21 | Neuren Pharmaceuticals Limited | Results Trofinetide significant clinical benefit in Rett syndrome neurenpharma.com ↗
Neuren Pharmaceuticals (ASX: NEU) today reported top-line results for its Phase 2 clinical trial in girls with Rett syndrome aged 5 to 15. |
| 2016-04-25 | Neuren Pharmaceuticals Limited | Results Results of Phase 2 trial in moderate to severe TBI neurenpharma.com ↗ |
| 2015-12-06 | Neuren Pharmaceuticals Limited | Results Trofinetide successful in Phase 2 trial in Fragile X neurenpharma.com ↗
Neuren Pharmaceuticals (ASX: NEU) today announced top-line results from its Phase 2 clinical trial in Fragile X syndrome. |
| 2015-10-11 | Neuren Pharmaceuticals Limited | Regulatory New US patent covering use of trofinetide for Rett syndrome neurenpharma.com ↗
Neuren Pharmaceuticals (ASX: NEU) today announced that, following examination, the US Patent and Trademark Office has issued a Notice of Allowance for a new patent concerning the use of trofinetide to treat Rett syndrome. |
| 2015-08-12 | Neuren Pharmaceuticals Limited | Regulatory Neuren confirms orphan drug designations in Europe neurenpharma.com ↗
Neuren Pharmaceuticals (ASX: NEU) today reported that the European Commission has formally adopted the decision to grant Orphan Designation to Neuren’s trofinetide for both Rett syndrome and Fragile X syndrome in the European Union (EU). |
| 2015-07-30 | Neuren Pharmaceuticals Limited | Results Investor presentation, 31 July 2015 neurenpharma.com ↗
Both dose levels were well tolerated and no safety concerns were identified |
| 2015-07-29 | Neuren Pharmaceuticals Limited | Regulatory Neuren reports progress in orphan drug programs neurenpharma.com ↗
The Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has recommended that Orphan designation be granted for trofinetide in both Rett syndrome and Fragile X syndrome. |
| 2015-03-01 | Neuren Pharmaceuticals Limited | Regulatory Neuren receives response to request for Breakthrough Therapy neurenpharma.com ↗
However, Breakthrough Therapy will not be granted at this time because the FDA considered that data from Neuren’s exploratory Phase 2 trial provide insufficient evidence to demonstrate substantial improvement over existing therapies using conventional statistical methods. |
| 2015-02-15 | Neuren Pharmaceuticals Limited | Regulatory FDA grants Neuren Orphan Drug designation for Rett syndrome neurenpharma.com ↗
Neuren Pharmaceuticals (ASX: NEU) today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug designation to Neuren’s drug trofinetide for treatment of Rett syndrome. |
| 2015-01-28 | Neuren Pharmaceuticals Limited | Regulatory Neuren announces trofinetide as proposed INN for NNZ-2566 neurenpharma.com ↗
The proposal is subject to a four-month period for comment before trofinetide can be confirmed as the INN. |
| 2014-12-30 | Neuren Pharmaceuticals Limited | Regulatory Neuren submits Orphan Drug/Breakthrough Therapy applications neurenpharma.com ↗
Neuren Pharmaceuticals (ASX: NEU) today announced that that it has submitted applications to the US Food and Drug Administration (FDA) for Orphan Drug designation and Breakthrough Therapy designation for NNZ-2566 in Rett syndrome. |
| 2014-11-11 | Neuren Pharmaceuticals Limited | Results Neuren successful in Rett syndrome Phase 2 trial neurenpharma.com ↗ |
| 2014-07-10 | Neuren Pharmaceuticals Limited | Regulatory Neuren receives ethics approval to start Concussion trial neurenpharma.com ↗
Neuren Pharmaceuticals (ASX: NEU) announced today that it has received approval from the Institutional Review Board at Womack Army Medical Centre to start the Phase 2 clinical trial of NNZ-2566 in concussion (also referred to as mild traumatic brain injury). |
All press releases naming this drug 92 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Trofinetide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04279314 ↗ |
| Known as | (2S)-2-{[(2S)-1-(2-aminoacetyl)-2-methylpyrrolidine-2-carbonyl]amino}pentanedioic acid | “Trofinetide ((2S)-2-{[(2S)-1-(2-aminoacetyl)-2-methylpyrrolidine-2-carbonyl]amino}pentanedioic acid) is derived from the tripeptide glycine-proline-glutamic acid (GPE), which...” PMID 37460385 ↗ Jul 2023 |
| Known as | ACP-2566 | ChEMBL registry synonym — accepted as the source's own label CHEMBL197084 ↗ |
| Known as | Daybue | ChEMBL registry synonym — accepted as the source's own label CHEMBL197084 ↗ |
| Known as | Experimental name: NNZ-2566 | “Experimental name: NNZ-2566” NCT00961779 ↗ |
| Known as | Glycyl-L-2-Methylprolyl-L-Glutamic Acid | “Glycyl-L-2-Methylprolyl-L-Glutamic Acid (NNZ-2566) supplied as a lyophilized powder (2g in 50mL vials) for reconstitution with lemon flavoured cordial and Water for Injection.” NCT01420042 ↗1“Glycyl-L-2-Methylprolyl-L-Glutamic Acid (NNZ-2566) supplied as a lyophilized powder (2g in 50mL vials) for reconstitution with bicarbonate buffer and normal saline.” NCT00961779 ↗ |
| Known as | Glycyl-L-2-Methylpropyl-L-Glutamic Acid | “Glycyl-L-2-Methylpropyl-L-Glutamic Acid (NNZ-2566) supplied as a lyophilized powder (2g in 50mL vials or 3g in 30mL bottles) for reconstitution with strawberry flavored...” NCT01894958 ↗2“Glycyl-L-2-Methylpropyl-L-Glutamic Acid (NNZ-2566) supplied as a lyophilized powder (3g in 30 milliliter vials) for reconstitution with strawberry flavored solution 0.5% v/v in...” NCT02100150 ↗ “Glycyl-L-2-Methylpropyl-L-Glutamic Acid (NNZ-2566) supplied as a lyophilized powder (2g in 50mL vials) for reconstitution with strawberry flavored solution 0.5% v/v in Water...” NCT01703533 ↗ |
| Known as | NNZ-2566 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00961779 ↗ |
| Known as | Trofinetida | ChEMBL registry synonym — accepted as the source's own label CHEMBL197084 ↗ |
| Modality | Peptide | “is derived from the tripeptide glycine-proline-glutamic acid (GPE)” PMID 37460385 ↗ Jul 2023 |
| Route | Intravenous | “Solution for intravenous infusion.” NCT00805818 ↗ |
| Target | IGF1R | “it acts through the IGF-1 receptor on both neurons and glia” PMID 37460385 ↗ Jul 2023 |