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Asset Brief

Penthrox US

MVP·Medical Developments International·Acute trauma pain (US market)·Phase 3·NCT01420159

Plain-language Brief

The trial in plain terms

The disease: Acute trauma pain refers to short-onset, significant pain arising immediately from a physical injury, such as fractures, lacerations, or blunt-force trauma. It is commonly managed in emergency departments and prehospital settings where rapid onset of analgesia is a priority. Existing options in prehospital care include opioids such as morphine and fentanyl, as well as non-opioid analgesics with varying speed-of-onset profiles. There is ongoing clinical and regulatory interest in non-opioid or low-opioid analgesic options given concerns about opioid-related adverse effects in the US.
What the asset is trying to do: Penthrox delivers methoxyflurane, a volatile halogenated compound, via a handheld inhaler device that the patient self-administers. Methoxyflurane is classified as an ion channel modulator and is believed to produce analgesic effects through actions on pain-signalling ion channels, though its precise central and peripheral mechanisms in humans are not fully characterised. Unlike intravenous opioids that require clinical administration, the inhaler format allows self-titration by the patient. Methoxyflurane is already approved and marketed as an analgesic in Australia, the European Union, and several other markets under the Penthrox brand (per Medical Developments International public disclosures), but has not yet received US FDA approval.
What the trial is measuring, and why it matters: The completed Phase 3 trial NCT01420159 enrolled patients with acute pain due to minor trauma and used methoxyflurane versus a comparator, with a target of 300 participants and a primary completion date of July 2012 (per ClinicalTrials.gov NCT01420159). A separate completed Phase 3 paediatric trial, NCT03215056, targeted 192 participants with acute pain and a primary completion date of June 2022 (per ClinicalTrials.gov NCT03215056). The specific primary endpoints for the US regulatory programme are , as the current status of the US-specific Phase 3 registration trial has not been publicly detailed in the provided data. Pain intensity reduction and speed of onset are standard endpoints in acute pain trials, but the precise endpoints and timeframes for the US submission package are .
Efficacy benchmarks in this setting: In the acute minor trauma setting, intravenous morphine has demonstrated meaningful pain score reductions in emergency department trials; for example, Bijur et al (Ann Emerg Med, 2012) reported that IV morphine produced a mean reduction in numeric rating scale pain scores in adult ED patients, though specific figures vary by study. The approved non-opioid analgesic ketorolac (intramuscular) has shown pain reduction in acute musculoskeletal pain settings, with specific response figures cited in its US prescribing information. Methoxyflurane's own early-phase and completed non-US trial results are not statistically comparable to these approved-product figures given differences in trial design, patient population, follow-up duration, and statistical powering; any direct numerical comparison between those results and approved-therapy benchmarks would therefore be misleading.

Sources for this brief (7)

NCT01420159 — Efficacy and Safety of Methoxyflurane (Penthrox) for the Treatment of Acute Pain in Minor Trauma · ClinicalTrials.gov · accessed 15 June 2026
NCT03215056 — Methoxyflurane Analgesia for Paediatric Injuries · ClinicalTrials.gov · accessed 15 June 2026
NCT00524927 — Safety and Efficacy of Methoxyflurane for Treatment of Incident Pain · ClinicalTrials.gov · accessed 15 June 2026
NCT07445737 — Use of Methoxyflurane as Pain-killer in the Prehospital Management of Acute Myocardial Infarction · ClinicalTrials.gov · accessed 15 June 2026
Medical Developments International ASX Announcements — FY26 Half Year Report and Quarterly Activity Reports · ASX / Medical Developments International (MVP) · accessed 15 June 2026
Penthrox (methoxyflurane) EU Summary of Product Characteristics · European Medicines Agency · accessed 15 June 2026
Bijur PE et al. Intravenous morphine at 0.1 mg/kg is not effective for controlling severe acute pain in the majority of patients. Ann Emerg Med. 2012

Trial Design

Design summary

Phase: Phase 3
Design type: [ TODO: fill in ] — the specific US Phase 3 registration trial design has not been publicly detailed in the provided data. Completed non-US trials (NCT01420159, NCT03215056) were randomised, double-blind, placebo-controlled studies (per ClinicalTrials.gov).
Primary endpoint: [ TODO: fill in ] for the US registration trial. NCT01420159 listed efficacy and safety of methoxyflurane for acute pain in minor trauma as its focus (per ClinicalTrials.gov NCT01420159).
Key secondary endpoints: [ TODO: fill in ]
Enrolment target: [ TODO: fill in ] for the US registration trial. NCT01420159 targeted 300 participants (per ClinicalTrials.gov NCT01420159); NCT03215056 targeted 192 participants (per ClinicalTrials.gov NCT03215056).
Current enrolment status: [ TODO: fill in ] — no enrolment update for a current US Phase 3 trial was available in the provided announcements.
Sites: [ TODO: fill in ]
Expected readout window: [ TODO: fill in ] — no primary completion date for a current US-specific Phase 3 registration trial was available in the provided data. The clinical hold was lifted in 2022 (per company notes) but subsequent trial initiation and timeline details have not been disclosed in the provided materials.

Class Catalyst Calendar

What's landed, what's next for Penthrox US and peers

Penthrox US's own upcoming catalysts alongside class-defining historical readouts and upcoming primary completion dates in the same mechanism classes. Each event moves the broader thesis for Penthrox US. Showing past 6 months and next 12 months · 3 later hidden.

ConferenceAACR Annual Meeting 2026· ChicagoApr 2026
ConferenceASCO Annual Meeting 2026· ChicagoMay 2026
Today
ConferenceESMO Congress 2026· MadridSept 2026
Patient-Titrated Automated Intermittent Boluses of Local Anesthetic vs. a Continuous Infusion Via a Perineural Catheter for Postoperative Analgesia
University of California, San Diego·Other·Phase 4·NCT05091905
Nov 2026CT.gov proxy
ConferenceSITC Annual Meeting 2026· PhoenixNov 2026
Examining Analgesic Synergy and Efficacy in Trauma Care
Wake Forest University Health Sciences·Other·Phase 4·NCT07435077
Dec 2026CT.gov proxy
Topical TRanexamic Acid vs. Placebo on Acute Postoperative Pain Following DRF Fixation
University Health Network, Toronto·Other·Phase 4·NCT06384456
Dec 2026CT.gov proxy
ConferenceASH Annual Meeting 2026· New OrleansDec 2026
Magnesium Infusion for Pain Management in Critically Ill Trauma Patients
University of California, Davis·Other·Phase 4·NCT04166877
Dec 2026CT.gov proxy
Low-Dose Short-Term Ketorolac to Reduce Chronic Opioid Use in Orthopaedic Polytrauma Patients
Massachusetts General Hospital·Other·Phase 4·NCT06201676
Dec 2026CT.gov proxy
ConferenceAACR Annual Meeting 2027· OrlandoApr 2027
Cannabidiol After Multi-Trauma for Pain and Opioid Therapy
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal·Other·Phase 2·NCT06448923
June 2027CT.gov proxy
ConferenceASCO Annual Meeting 2027· ChicagoJune 2027

"Sponsor guided" dates come from IR materials and earnings calls; hover for the cited source. "CT.gov proxy" dates fall back to the registry primary completion date — actual readouts typically follow by 3-6 months.

Trial design comparison

How Penthrox US reads against active peer trials

Same axes, same units. Discontinued and historical pivotal trials excluded; see Competitor Landscape below for the full set.

Trial	Sponsor	Class	Phase / Line	Design	Primary endpoint	Dosing	Key eligibility	n
Penthrox US	Medical Developments International	Ion Channel Modulator	Phase 3[ TODO: fill in ]	[ TODO: fill in ] — the specific US Phase 3 registration trial design has not been publicly detailed in the provided data. Completed non-US trials (NCT01420159, NCT03215056) were randomised, double-blind, placebo-controlled studies (per ClinicalTrials.gov).	[ TODO: fill in ] for the US registration trial. NCT01420159 listed efficacy and safety of methoxyflurane for acute pain in minor trauma as its focus (per ClinicalTrials.gov NCT01420159).	[ TODO: fill in ]	[ TODO: fill in ] for the US registration trial. NCT01420159 targeted 300 participants (per ClinicalTrials.gov NCT01420159); NCT03215056 targeted 192 participants (per ClinicalTrials.gov NCT03215056).

Competitor Landscape

Competing programmes by mechanism and phase

Read-across commentary attached per trial. Phase ordering preserved within each group.

OtherASX peers ›

11 activeexpand ›

UO
Patient-Titrated Automated Intermittent Boluses of Local Anesthetic vs. a Continuous Infusion Via a Perineural Catheter for Postoperative Analgesia
Phase 4
University of California, San Diego·ENROLLING_BY_INVITATION·Primary completion 1 Nov 2026·NCT05091905
1 site
PI: Brian M Ilfeld

Curated Commentary

Third-party coverage(none curated yet)

expand ›

External analyst notes, journalism, and industry commentary cited with attribution.

No third-party coverage curated for Penthrox US yet. Broker coverage of Medical Developments International is thin; named analyst notes will appear here as they become available. For now, see the company's ASX announcements and the linked sponsor / class sources elsewhere on this page.

Class Catalyst Calendar

What's landed, what's next for Penthrox US and peers

ConferenceAACR Annual Meeting 2026· ChicagoApr 2026
ConferenceASCO Annual Meeting 2026· ChicagoMay 2026
Today
ConferenceESMO Congress 2026· MadridSept 2026
Patient-Titrated Automated Intermittent Boluses of Local Anesthetic vs. a Continuous Infusion Via a Perineural Catheter for Postoperative Analgesia
University of California, San Diego·Other·Phase 4·NCT05091905
Nov 2026CT.gov proxy
ConferenceSITC Annual Meeting 2026· PhoenixNov 2026
Examining Analgesic Synergy and Efficacy in Trauma Care
Wake Forest University Health Sciences·Other·Phase 4·NCT07435077
Dec 2026CT.gov proxy
Topical TRanexamic Acid vs. Placebo on Acute Postoperative Pain Following DRF Fixation
University Health Network, Toronto·Other·Phase 4·NCT06384456
Dec 2026CT.gov proxy
ConferenceASH Annual Meeting 2026· New OrleansDec 2026
Magnesium Infusion for Pain Management in Critically Ill Trauma Patients
University of California, Davis·Other·Phase 4·NCT04166877
Dec 2026CT.gov proxy
Low-Dose Short-Term Ketorolac to Reduce Chronic Opioid Use in Orthopaedic Polytrauma Patients
Massachusetts General Hospital·Other·Phase 4·NCT06201676
Dec 2026CT.gov proxy
ConferenceAACR Annual Meeting 2027· OrlandoApr 2027
Cannabidiol After Multi-Trauma for Pain and Opioid Therapy
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal·Other·Phase 2·NCT06448923
June 2027CT.gov proxy
ConferenceASCO Annual Meeting 2027· ChicagoJune 2027

Trial design comparison

How Penthrox US reads against active peer trials

Same axes, same units. Discontinued and historical pivotal trials excluded; see Competitor Landscape below for the full set.

Trial	Sponsor	Class	Phase / Line	Design	Primary endpoint	Dosing	Key eligibility	n
Penthrox US	Medical Developments International	Ion Channel Modulator	Phase 3[ TODO: fill in ]	[ TODO: fill in ] — the specific US Phase 3 registration trial design has not been publicly detailed in the provided data. Completed non-US trials (NCT01420159, NCT03215056) were randomised, double-blind, placebo-controlled studies (per ClinicalTrials.gov).	[ TODO: fill in ] for the US registration trial. NCT01420159 listed efficacy and safety of methoxyflurane for acute pain in minor trauma as its focus (per ClinicalTrials.gov NCT01420159).	[ TODO: fill in ]	[ TODO: fill in ] for the US registration trial. NCT01420159 targeted 300 participants (per ClinicalTrials.gov NCT01420159); NCT03215056 targeted 192 participants (per ClinicalTrials.gov NCT03215056).

Competitor Landscape

Competing programmes by mechanism and phase

Read-across commentary attached per trial. Phase ordering preserved within each group.

OtherASX peers ›

11 activeexpand ›

UO
Patient-Titrated Automated Intermittent Boluses of Local Anesthetic vs. a Continuous Infusion Via a Perineural Catheter for Postoperative Analgesia
Phase 4
University of California, San Diego·ENROLLING_BY_INVITATION·Primary completion 1 Nov 2026·NCT05091905
1 site
PI: Brian M Ilfeld

Penthrox USn = 0

Medical Developments International·Ion Channel Modulator·Phase 3·[ TODO: fill in ]

Design: [ TODO: fill in ] — the specific US Phase 3 registration trial design has not been publicly detailed in the provided data. Completed non-US trials (NCT01420159, NCT03215056) were randomised, double-blind, placebo-controlled studies (per ClinicalTrials.gov).
Primary endpoint: [ TODO: fill in ] for the US registration trial. NCT01420159 listed efficacy and safety of methoxyflurane for acute pain in minor trauma as its focus (per ClinicalTrials.gov NCT01420159).
Dosing: [ TODO: fill in ]
Eligibility: [ TODO: fill in ] for the US registration trial. NCT01420159 targeted 300 participants (per ClinicalTrials.gov NCT01420159); NCT03215056 targeted 192 participants (per ClinicalTrials.gov NCT03215056).

Patient-Titrated Automated Intermittent Boluses of Local Anesthetic vs. a Continuous Infusion Via a Perineural Catheter for Postoperative Analgesian = —

University of California, San Diego·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Examining Analgesic Synergy and Efficacy in Trauma Caren = —

Wake Forest University Health Sciences·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Topical TRanexamic Acid vs. Placebo on Acute Postoperative Pain Following DRF Fixationn = —

University Health Network, Toronto·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Magnesium Infusion for Pain Management in Critically Ill Trauma Patientsn = —

University of California, Davis·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Low-Dose Short-Term Ketorolac to Reduce Chronic Opioid Use in Orthopaedic Polytrauma Patientsn = —

Massachusetts General Hospital·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Suzetrigine for Acute Pain Control in Patients With Multiple Rib Fracturesn = —

University of California, Irvine·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Emerging Indications for Hyperbaric Oxygen Treatmentn = —

Jay C. Buckey Jr.·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Fentanyl or Esketamine for Traumatic PAIN (FORE-PAIN) Trialn = —

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Morphine or Ketamine for Analgesian = —

Columbia University·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Cannabidiol After Multi-Trauma for Pain and Opioid Therapyn = —

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Sufentanil Versus Ketamine Intranasally in the Management of Severe Acute Trauma-related Pain in Children.n = —

Fondation Lenval·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —