Drugs / CT001
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Refused (EMA) | EU (EMA) | KemSu | acute pain in children | 2026-07-24 | “CHMP has adopted a negative opinion on the Paediatric Use Marketing Authorisation (PUMA) application for CT001/KemSu” cessatech.com ↗ |
| Filed | EU (EMA) | — | acute pain in children | 2025-08-14 | “Proveca has submitted a Paediatric Use Marketing Authorisation (PUMA) application for CT001 (ketamine/sufentanil nasal spray) to the EMA” cessatech.com ↗ “Proveca and Cessatech announce MAA submission for CT001 to EMA on 14 August 2025.” proveca.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04807335 | Mar → Jun 2021 | — | Cessatech A/S | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05508594 | Sep 2022 → Oct 2023 | — | Cessatech A/S | Completed | Mixed |
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2026-09-27 | Cessatech A/S | Results EUSEM Press release: Nasal spray brings pain relief for children treated in the emergency department cessatech.com ↗
A treatment for pain, that is delivered via a nasal spray, offers an effective, needle-free option for children being seen in the emergency department for a range of injuries |
| 2026-07-24 | Cessatech A/S | Regulatory Proveca intends to request a re-examination of CHMP opinion for CT001/KemSu cessatech.com ↗
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion on the Paediatric Use Marketing Authorisation (PUMA) application for CT001/KemSu (intranasal sufentanil/ketamine). |
| 2026-03-12 | Cessatech A/S | Results Poster session: comparing the results of Study 0202 in children with simulated data from adults. cessatech.com ↗
Showing an almost identical match between simulated and clinical evidence, and this presentation is a strong reminder that Study 0202 demonstrates how well CT001 works in paediatric acute pain management. |
| 2025-08-21 | Proveca Pharma Limited | Regulatory This press release is intended for investors only – The Marketing Authorisation Application (MAA) for CT001 is submitted to the European Medicines Agency (EMA) for acute pain management in children proveca.com ↗
Proveca and Cessatech announce MAA submission for CT001 to EMA on 14 August 2025. |
| 2025-08-14 | Cessatech A/S | Regulatory Marketing Authorisation Application (MAA) for CT001 has been submitted to the European Medicines Agency (EMA) for acute pain management in children cessatech.com ↗
The Marketing Authorisation Application (MAA) for CT001 is submitted to the European Medicines Agency (EMA) for acute pain management in children |
| 2025-05-28 | Cessatech A/S | Results Positive top-line results from its final CT001 Study 0202 cessatech.com ↗
The primary endpoint of responder analysis, of pain relief (pain score ≤4/10), was met and reported by 54% of patients after 15 minutes and by 88% after 30 minutes. |
| 2025-02-04 | Cessatech A/S | Regulatory Positive Notified Body opinion under MDR for CT001 cessatech.com ↗
On 4 February – Cessatech A/S (“Cessatech” or “the Company”) announces that the Company has received a positive Notified Body Opinion under Article 117 of the Medical Devices Regulation (EU) 2017/745 (MDR) for its lead asset CT001. |
| 2024-06-28 | Cessatech A/S | Results New data on paediatric pain relief at the PAGE conference in Rome favouring its lead candidate CT001 cessatech.com ↗
The new significant findings revealed that relative drug exposure is much higher in young children, with bioavailability decreasing with age. |
| 2024-06-03 | Cessatech A/S | Results Cessatech announces superior simulated pain efficacy in children cessatech.com ↗
The simulated pain reduction in NRS in children using CT001 was -87%, compared to -52%, -32% and +10% for sufentanil, ketamine and placebo respectively. |
| 2023-12-22 | Cessatech A/S | Results Positive topline data from study 0205 with its lead candidate CT001 for the treatment of pain in children supporting further advancement of CT001 cessatech.com ↗
Cessatech A/S (“Cessatech” or “the Company”) today announced topline results from the double-blind, randomised, placebo-controlled 0205 study that investigated efficacy, safety, and tolerability of CT001 as postoperative analgesic treatment in adults, following impacted mandibular third molar extraction. |
| 2023-10-25 | Cessatech A/S | Regulatory Cessatech announces that the Paediatric Committee has agreed to a 50% reduction of the required number of patients in the final study of its nasal spray for the treatment of acute pain in children cessatech.com ↗
The European Paediatric Committee (PDCO) has agreed to a 50% reduction in the number of children required in the final safety study (0202) of CT001 for the treatment of acute and procedural pain in children |
| 2022-09-23 | Cessatech A/S | Results Successful outcome of pharmacokinetic trial in children of lead candidate cessatech.com ↗
Cessatech A/S announces positive topline outcome of its Phase 2 pharmacokinetics trial with CT001 in children, which met the primary endpoint of the trial. |
| 2022-06-30 | Cessatech A/S | Regulatory Regulatory Green Light for trial 0205, the pivotal trial for CT001 – first patient expected shortly cessatech.com ↗
Cessatech A/S announces that the pivotal trial 0205 has obtained regulatory approval and thereby green light by the authorities and is now ready to initiate patient recruitment. |
| 2022-03-08 | Cessatech A/S | Results Successful outcome from trial 0204 cessatech.com ↗
Topline results of clinical trial 0204 investigating the absolute bioavailability of CT001 showed clinical relevant exposures following nasal administration. |
| 2021-03-04 | Cessatech A/S | Results Favourable data from the Registry Safety Study cessatech.com ↗
The Registry Safety Study indicates a favourable safety profile for the CT001, containing a ‘fixed and ready to use’ combination of sufentanil and ketamine. |
All press releases naming this drug 24 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CT001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04807335 ↗ |
| Route | Intranasal | “intranasal dosage of CT001” NCT04807335 ↗ |